Post-Marketing Safety Surveillance: Detecting Adverse Events
•Download as PPTX, PDF•
0 likes•35 views
Post-marketing safety surveillance, also known as post-marketing pharmacovigilance, is a critical process in monitoring the safety of pharmaceutical products after they have been approved and are available in the market. It involves the systematic collection, analysis, and evaluation of real-world data to identify and assess adverse events and other safety-related issues associated with medications. Here's an overview of how post-marketing safety surveillance detects adverse events
Report
Share
Report
Share
Recommended
Adapting Clinical Trials During a Global Pandemic: Lessons Learned
The COVID-19 pandemic has had a significant impact on clinical trials worldwide, requiring rapid adaptations to ensure patient safety, data integrity, and the continuity of research efforts. Several key lessons have been learned during this challenging time:
Flexibility and Adaptability: The pandemic highlighted the importance of flexibility in clinical trial design and operations. Researchers and regulatory bodies had to quickly adapt protocols to accommodate remote visits, decentralized approaches, and virtual assessments. Being able to modify protocols and implement alternative strategies allowed trials to continue while minimizing disruptions.
Remote Monitoring and Data Collection: Remote monitoring and data collection became crucial during the pandemic to ensure patient safety and collect data without in-person visits. Technologies such as wearable devices, telemedicine platforms, and electronic patient-reported outcomes (ePROs) played a significant role in enabling remote data collection and reducing the need for site visits.
Patient-Centric Approaches: The pandemic emphasized the importance of considering patients' needs and preferences. Remote visits, home healthcare services, and decentralized trial models were implemented to reduce the burden on patients and ensure their safety. Patient engagement and education became even more critical to maintain participation and retention in trials.
Regulatory Flexibility: Regulatory agencies recognized the need for flexibility during the pandemic and implemented measures to expedite trial approvals and amendments. They provided guidance on remote monitoring, virtual visits, and other alternative approaches, allowing researchers to adapt quickly while ensuring patient safety and data integrity.
Post-Marketing Surveillance: Monitoring Drug Safety After Approval
Post-marketing surveillance, also known as post-marketing monitoring or pharmacovigilance, is a critical component of drug safety monitoring that occurs after a pharmaceutical product has been approved and is available on the market. It involves the systematic collection, analysis, and evaluation of real-world data to detect and assess any previously unrecognized adverse effects or other drug-related problems. Here are the key aspects of post-marketing surveillance and its role in monitoring drug safety after approval:
Adverse Event Reporting: Post-marketing surveillance relies on the reporting of adverse events (AEs) by healthcare professionals, patients, and pharmaceutical companies. These reports, known as spontaneous or voluntary reports, provide valuable information about potential drug-related issues encountered in real-world clinical practice.
Signal Detection: Post-marketing surveillance aims to detect signals, which are patterns or associations between a drug and an adverse event that may suggest a previously unrecognized safety concern. Signals are identified through various sources, including spontaneous reports, scientific literature, electronic health records, and other healthcare databases.
Data Collection: Post-marketing surveillance collects data from diverse sources, such as individual case safety reports (ICSRs), observational studies, registries, clinical trials, and electronic health records. These sources provide a wealth of real-world data that can help identify safety signals and generate evidence regarding drug safety in broader patient populations.
Risk Assessment: The collected data are analyzed and assessed to evaluate the potential risks associated with a drug. This involves analyzing the frequency, severity, and potential causal relationship between the drug and adverse events. Risk assessment helps determine the magnitude and significance of safety concerns and guides regulatory decisions and risk management strategies.
Benefit-Risk Assessment: Post-marketing surveillance supports ongoing benefit-risk assessments of drugs. It involves weighing the potential benefits of the drug against the identified risks and any additional safety concerns that arise during the post-marketing phase. This assessment ensures that the overall benefit-risk profile of the drug remains favorable and justifies its continued use.
Signal Validation: Signals detected through post-marketing surveillance undergo further investigation and validation to confirm their association with the drug. This may involve conducting additional studies, including observational studies, epidemiological research, and clinical trials, to gather more evidence and evaluate causality.
Signal detection and their assessment in clinical trials
Signal detection in clinical trials is a crucial aspect of pharmacovigilance that involves identifying potential safety concerns or signals associated with the use of investigational drugs. The process of signal detection is ongoing throughout the life cycle of a drug, from early-phase trials to post-marketing surveillance. Here's an overview of signal detection and the assessment process in clinical trials
Signal Validation and Causality Assessment in Adverse Event Reporting
Signal validation and causality assessment are essential components of pharmacovigilance, which is the science and activities related to monitoring, assessing, and preventing adverse effects or any other drug-related problems. Pharmacovigilance plays a crucial role in ensuring the safety of drugs and medical products after they have been approved and are available on the market.
post marketing surveillance OF DRUG PRODUCTS
Postmarketing surveillance (PMS) involves monitoring the safety of pharmaceutical drugs and medical devices after they have been approved for public use. PMS is important because pre-approval clinical trials involve relatively small numbers of participants and may not detect rare or long-term adverse effects. PMS uses various methods like spontaneous reporting, cohort studies, and case-control studies to monitor drug and device safety in larger populations over longer time periods after approval. The goal of PMS is to further evaluate or confirm the safety profile of products as they are used in real-world clinical settings by more diverse patients than clinical trials.
Pharmacovigilance and Drug safety
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It plays a crucial role in ensuring the safety and monitoring the risks associated with pharmaceutical products throughout their lifecycle, from pre-market clinical trials to post-marketing surveillance.
Here are some key aspects of pharmacovigilance and drug safety:
Adverse Drug Reaction (ADR) Monitoring: Pharmacovigilance systems aim to identify and monitor adverse drug reactions, which are harmful and unintended responses to medications. Healthcare professionals and patients are encouraged to report suspected ADRs to regulatory authorities or pharmacovigilance programs, enabling the ongoing collection and analysis of safety data.
Signal Detection: Pharmacovigilance activities involve the systematic monitoring and analysis of safety data to identify potential signals or patterns that may indicate new or previously unrecognized risks associated with a drug. This involves the use of various tools and methods, such as data mining, statistical analysis, and signal management, to detect and investigate potential safety concerns.
Benefit-Risk Assessment: Pharmacovigilance plays a critical role in assessing the balance between the benefits and risks of medications. By collecting and analyzing safety data from various sources, including clinical trials and post-marketing surveillance, regulators and healthcare professionals can evaluate the overall benefit-risk profile of drugs and make informed decisions regarding their use.
Regulatory Reporting: Pharmaceutical companies are required to report safety data and suspected adverse reactions to regulatory authorities as part of their regulatory obligations. These reports provide important information for regulatory decision-making, including labeling updates, contraindications, or restrictions on drug use.
Post-Marketing Surveillance: Once a drug is approved and available on the market, pharmacovigilance activities continue to monitor its safety in real-world clinical practice. Post-marketing surveillance systems track and evaluate the safety of drugs in larger and more diverse patient populations, detecting rare or long-term adverse events that may not have been identified during clinical trials.
Risk Management Strategies: Pharmacovigilance also involves the development and implementation of risk management strategies to minimize or mitigate known risks associated with specific drugs. This may include prescribing restrictions, monitoring requirements, educational materials for healthcare professionals and patients, and communication of safety information.
International Collaboration: Pharmacovigilance operates on a global scale, with international collaboration and information sharing being essential for timely detection and response to drug safety issues. Regulatory agencies, healthcare organizations, and pharmacovigilance netw
Post marketing servillence
This document discusses post-marketing surveillance (PMS), which involves monitoring the safety of pharmaceutical drugs after they have been approved and released on the market. PMS is important because pre-approval clinical trials involve relatively small groups of patients and may miss rare or long-term adverse effects only seen in larger populations. The document outlines various methods for PMS, including spontaneous reporting, cohort studies, and case-control studies. It also discusses the benefits of PMS for improving product quality and safety monitoring, as well as manufacturers' role in establishing PMS procedures and evaluating feedback.
Post marketing servillence
This document discusses post-marketing surveillance (PMS), which involves monitoring the safety of pharmaceutical drugs and medical devices after they have been approved and released on the market. PMS is important because pre-approval clinical trials involve limited numbers of patients and cannot detect all potential adverse effects. The document outlines the history of PMS, sources of PMS information, benefits of PMS systems, methods of surveillance including spontaneous reporting and cohort studies, and how manufacturers can establish PMS procedures and systems to gather feedback on their products.
Recommended
Adapting Clinical Trials During a Global Pandemic: Lessons Learned
The COVID-19 pandemic has had a significant impact on clinical trials worldwide, requiring rapid adaptations to ensure patient safety, data integrity, and the continuity of research efforts. Several key lessons have been learned during this challenging time:
Flexibility and Adaptability: The pandemic highlighted the importance of flexibility in clinical trial design and operations. Researchers and regulatory bodies had to quickly adapt protocols to accommodate remote visits, decentralized approaches, and virtual assessments. Being able to modify protocols and implement alternative strategies allowed trials to continue while minimizing disruptions.
Remote Monitoring and Data Collection: Remote monitoring and data collection became crucial during the pandemic to ensure patient safety and collect data without in-person visits. Technologies such as wearable devices, telemedicine platforms, and electronic patient-reported outcomes (ePROs) played a significant role in enabling remote data collection and reducing the need for site visits.
Patient-Centric Approaches: The pandemic emphasized the importance of considering patients' needs and preferences. Remote visits, home healthcare services, and decentralized trial models were implemented to reduce the burden on patients and ensure their safety. Patient engagement and education became even more critical to maintain participation and retention in trials.
Regulatory Flexibility: Regulatory agencies recognized the need for flexibility during the pandemic and implemented measures to expedite trial approvals and amendments. They provided guidance on remote monitoring, virtual visits, and other alternative approaches, allowing researchers to adapt quickly while ensuring patient safety and data integrity.
Post-Marketing Surveillance: Monitoring Drug Safety After Approval
Post-marketing surveillance, also known as post-marketing monitoring or pharmacovigilance, is a critical component of drug safety monitoring that occurs after a pharmaceutical product has been approved and is available on the market. It involves the systematic collection, analysis, and evaluation of real-world data to detect and assess any previously unrecognized adverse effects or other drug-related problems. Here are the key aspects of post-marketing surveillance and its role in monitoring drug safety after approval:
Adverse Event Reporting: Post-marketing surveillance relies on the reporting of adverse events (AEs) by healthcare professionals, patients, and pharmaceutical companies. These reports, known as spontaneous or voluntary reports, provide valuable information about potential drug-related issues encountered in real-world clinical practice.
Signal Detection: Post-marketing surveillance aims to detect signals, which are patterns or associations between a drug and an adverse event that may suggest a previously unrecognized safety concern. Signals are identified through various sources, including spontaneous reports, scientific literature, electronic health records, and other healthcare databases.
Data Collection: Post-marketing surveillance collects data from diverse sources, such as individual case safety reports (ICSRs), observational studies, registries, clinical trials, and electronic health records. These sources provide a wealth of real-world data that can help identify safety signals and generate evidence regarding drug safety in broader patient populations.
Risk Assessment: The collected data are analyzed and assessed to evaluate the potential risks associated with a drug. This involves analyzing the frequency, severity, and potential causal relationship between the drug and adverse events. Risk assessment helps determine the magnitude and significance of safety concerns and guides regulatory decisions and risk management strategies.
Benefit-Risk Assessment: Post-marketing surveillance supports ongoing benefit-risk assessments of drugs. It involves weighing the potential benefits of the drug against the identified risks and any additional safety concerns that arise during the post-marketing phase. This assessment ensures that the overall benefit-risk profile of the drug remains favorable and justifies its continued use.
Signal Validation: Signals detected through post-marketing surveillance undergo further investigation and validation to confirm their association with the drug. This may involve conducting additional studies, including observational studies, epidemiological research, and clinical trials, to gather more evidence and evaluate causality.
Signal detection and their assessment in clinical trials
Signal detection in clinical trials is a crucial aspect of pharmacovigilance that involves identifying potential safety concerns or signals associated with the use of investigational drugs. The process of signal detection is ongoing throughout the life cycle of a drug, from early-phase trials to post-marketing surveillance. Here's an overview of signal detection and the assessment process in clinical trials
Signal Validation and Causality Assessment in Adverse Event Reporting
Signal validation and causality assessment are essential components of pharmacovigilance, which is the science and activities related to monitoring, assessing, and preventing adverse effects or any other drug-related problems. Pharmacovigilance plays a crucial role in ensuring the safety of drugs and medical products after they have been approved and are available on the market.
post marketing surveillance OF DRUG PRODUCTS
Postmarketing surveillance (PMS) involves monitoring the safety of pharmaceutical drugs and medical devices after they have been approved for public use. PMS is important because pre-approval clinical trials involve relatively small numbers of participants and may not detect rare or long-term adverse effects. PMS uses various methods like spontaneous reporting, cohort studies, and case-control studies to monitor drug and device safety in larger populations over longer time periods after approval. The goal of PMS is to further evaluate or confirm the safety profile of products as they are used in real-world clinical settings by more diverse patients than clinical trials.
Pharmacovigilance and Drug safety
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It plays a crucial role in ensuring the safety and monitoring the risks associated with pharmaceutical products throughout their lifecycle, from pre-market clinical trials to post-marketing surveillance.
Here are some key aspects of pharmacovigilance and drug safety:
Adverse Drug Reaction (ADR) Monitoring: Pharmacovigilance systems aim to identify and monitor adverse drug reactions, which are harmful and unintended responses to medications. Healthcare professionals and patients are encouraged to report suspected ADRs to regulatory authorities or pharmacovigilance programs, enabling the ongoing collection and analysis of safety data.
Signal Detection: Pharmacovigilance activities involve the systematic monitoring and analysis of safety data to identify potential signals or patterns that may indicate new or previously unrecognized risks associated with a drug. This involves the use of various tools and methods, such as data mining, statistical analysis, and signal management, to detect and investigate potential safety concerns.
Benefit-Risk Assessment: Pharmacovigilance plays a critical role in assessing the balance between the benefits and risks of medications. By collecting and analyzing safety data from various sources, including clinical trials and post-marketing surveillance, regulators and healthcare professionals can evaluate the overall benefit-risk profile of drugs and make informed decisions regarding their use.
Regulatory Reporting: Pharmaceutical companies are required to report safety data and suspected adverse reactions to regulatory authorities as part of their regulatory obligations. These reports provide important information for regulatory decision-making, including labeling updates, contraindications, or restrictions on drug use.
Post-Marketing Surveillance: Once a drug is approved and available on the market, pharmacovigilance activities continue to monitor its safety in real-world clinical practice. Post-marketing surveillance systems track and evaluate the safety of drugs in larger and more diverse patient populations, detecting rare or long-term adverse events that may not have been identified during clinical trials.
Risk Management Strategies: Pharmacovigilance also involves the development and implementation of risk management strategies to minimize or mitigate known risks associated with specific drugs. This may include prescribing restrictions, monitoring requirements, educational materials for healthcare professionals and patients, and communication of safety information.
International Collaboration: Pharmacovigilance operates on a global scale, with international collaboration and information sharing being essential for timely detection and response to drug safety issues. Regulatory agencies, healthcare organizations, and pharmacovigilance netw
Post marketing servillence
This document discusses post-marketing surveillance (PMS), which involves monitoring the safety of pharmaceutical drugs after they have been approved and released on the market. PMS is important because pre-approval clinical trials involve relatively small groups of patients and may miss rare or long-term adverse effects only seen in larger populations. The document outlines various methods for PMS, including spontaneous reporting, cohort studies, and case-control studies. It also discusses the benefits of PMS for improving product quality and safety monitoring, as well as manufacturers' role in establishing PMS procedures and evaluating feedback.
Post marketing servillence
This document discusses post-marketing surveillance (PMS), which involves monitoring the safety of pharmaceutical drugs and medical devices after they have been approved and released on the market. PMS is important because pre-approval clinical trials involve limited numbers of patients and cannot detect all potential adverse effects. The document outlines the history of PMS, sources of PMS information, benefits of PMS systems, methods of surveillance including spontaneous reporting and cohort studies, and how manufacturers can establish PMS procedures and systems to gather feedback on their products.
The impact of real world data in pharmacovilgilance and regulatory decision m...
Real-world data (RWD) has revolutionized the field of pharmacovigilance and regulatory decision-making. While clinical trials provide valuable insights into the safety and efficacy of medications, RWD offers a comprehensive view of a drug's performance in real-world settings. In this blog post, we will explore the significant impact of RWD in pharmacovigilance and how it has transformed the way regulatory decisions are made. We will discuss the benefits of utilizing RWD, the challenges associated with its implementation, and its potential to improve patient safety and healthcare outcomes.
Phase 3
This document provides an overview of phase 3 clinical trials. Phase 3 trials involve large randomized controlled trials of up to 3000 patients to generate statistically significant data on a drug's safety and efficacy in different patient populations. The objectives are to demonstrate therapeutic efficacy and safety/tolerability in a representative sample. Results are submitted to regulatory agencies for marketing approval. Challenges include long duration, large sample sizes, high costs, and coordinating multiple study sites. If approved, the new drug application process requires submission of all safety, efficacy and manufacturing data to the regulatory agency for review and potential approval.
Canada’s Orphan Drug Regulatory Framework & panCanadian Access to Rare Diseas...
Canada’s Orphan Drug Regulatory Framework & panCanadian Access to Rare Diseas...Canadian Organization for Rare Disorders
The document discusses Canada's orphan drug regulatory framework and opportunities to improve access to rare disease drugs across Canada. It advocates for a life-cycle approach and managed access schemes where drugs are approved with evidence collection requirements. Traditional health technology assessment limits orphan drug access by rejecting drugs that are not cost-effective based on small clinical trials. The document recommends performance-based managed access programs with national guidelines and risk-sharing between provinces, patients, and companies to improve access while collecting long-term evidence on benefits, harms, and costs.Patient centered Pharmacovigilance .. .
Patient-centered pharmacovigilance represents a pivotal shift in the landscape of healthcare, emphasizing the active involvement of patients in the monitoring and reporting of adverse drug reactions. Unlike traditional pharmacovigilance, which primarily relies on healthcare professionals to identify and document adverse events, this approach recognizes patients as critical stakeholders in ensuring medication safety. By empowering patients to share their experiences, concerns, and observations regarding medication effects, whether positive or negative, healthcare systems can gain a comprehensive understanding of drug safety and efficacy in real-world settings. Patient-centered pharmacovigilance fosters a collaborative partnership between patients, healthcare providers, and regulatory agencies, promoting transparency, accountability, and ultimately, better patient outcomes. Through increased patient engagement and the utilization of patient-reported data, this approach enables healthcare systems to identify potential safety issues earlier, tailor treatment strategies to individual needs, and enhance overall drug safety surveillance efforts.
Signal detection and their assessment in clinical trials
Signal detection and assessment in clinical trials refer to the process of identifying potential safety concerns or unexpected events related to a study intervention, treatment, or medical product. It involves monitoring and analyzing data collected during the trial to detect any patterns, trends, or signals that might indicate a safety issue. This proactive approach helps ensure the safety of participants and enables timely interventions if necessary.
Here's an overview of the process of signal detection and assessment in clinical trials:
Pharmacovigilance Training in Oracle Argus Safety Database
Pharmacovigilance training is essential for pharmaceutical and healthcare organizations to ensure your operations comply with the latest regulatory guidelines, laws and standards. At Gratisol Labs, we provide industry-leading pharmacovigilance training courses with hands on experience on safety databases & medical coding that cover the basics of Pharmacovigilance till advanced drug safety topics, the regulatory requirements of pharmacovigilance, signal detection, and pharmacovigilance audits are covered in the complete Gratisol Labs Pharmacovigilance Training Programme.
Vaccine Safety Monitoring: Pharmacovigilance Strategies
Vaccine safety monitoring is a critical aspect of pharmacovigilance, particularly given the widespread use of vaccines to prevent infectious diseases. Robust surveillance systems are essential to detect and assess any potential adverse events following vaccination. Here are some key pharmacovigilance strategies employed for vaccine safety monitoring:
Passive Surveillance Systems:
Passive surveillance systems rely on healthcare providers, patients, and other stakeholders to voluntarily report adverse events following vaccination. These reports are collected in databases such as the Vaccine Adverse Event Reporting System (VAERS) in the United States or the Vaccine Adverse Event Surveillance System (VAESS) in other countries. While these systems are valuable for signal detection, they may suffer from underreporting and reporting bias.
Active Surveillance Systems:
Active surveillance involves proactively monitoring a defined population for adverse events following vaccination. This can be done through electronic health records (EHRs), claims databases, and other health data sources. The Vaccine Safety Datalink (VSD) in the United States is an example of an active surveillance system that uses large databases to continuously monitor vaccine safety.
Enhanced Surveillance and Cohort Studies:
Enhanced surveillance involves more intensive monitoring of a specific population or group of interest. Cohort studies are prospective studies that follow a group of vaccinated individuals over time to assess vaccine safety. These studies provide more detailed and controlled data compared to passive or active surveillance.
Comparative Effectiveness Research:
Comparative effectiveness research compares the safety of different vaccines or vaccination schedules. By analyzing large datasets, researchers can evaluate the relative risks and benefits of vaccines and identify any safety concerns.
Signal Detection and Analysis:
Data mining and statistical techniques are used to identify potential safety signals from adverse event reports. Signals are further investigated through in-depth analysis to determine if there is a causal relationship between the vaccine and the adverse event.
Causality Assessment:
Similar to general pharmacovigilance, causality assessment methods (such as the Naranjo Algorithm, WHO-UMC System, and Bayesian methods) are used to evaluate the likelihood of a causal relationship between a vaccine and an adverse event.
Risk Communication and Public Awareness:
Effective communication strategies are crucial to ensure that healthcare providers and the public are informed about vaccine safety. This involves providing clear and accurate information about potential risks and benefits.
TGA presentation: Postmarket Monitoring
View this presentation for information on:
what postmarket monitoring is and why it is important
tools used in postmarket monitoring, including risk management plans
managing risk and adverse events
the TGA's early warning system and recall actions.
POST MARKETING SURVILLANCE
This document discusses post-marketing surveillance of pharmaceuticals. Post-marketing surveillance involves monitoring drugs after they are approved for public use to identify safety risks. It can involve controlled clinical trials, spontaneous reporting of adverse events, cohort studies, and case-control studies. The FDA Adverse Event Reporting System collects over a million reports annually to detect unknown risks and safety issues not found in clinical trials. Post-marketing surveillance is important for monitoring long-term effects and risks in broader patient populations than clinical trials.
postmarketing surviellance,,outsourcing of BA ,BE , CRO.
This document provides an overview of post-marketing surveillance, outsourcing of bioavailability and bioequivalence studies to contract research organizations. It discusses the need for post-marketing surveillance to identify rare or long-term adverse drug reactions not seen in clinical trials. Methods for post-marketing surveillance include controlled trials, spontaneous reporting, cohort and case-control studies. Outsourcing bioavailability and bioequivalence studies to CROs can help reduce costs and improve resource efficiency for pharmaceutical companies.
Pharmacovigilance in Special Populations: Considerations for Pediatric and Ge...
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. When it comes to special populations, such as pediatric and geriatric patients, there are specific considerations that need to be taken into account in pharmacovigilance efforts. Here are some key points regarding pharmacovigilance in these population
How Big Data Transforms Reactive Drug Safety to Proactive Pharmacovigilance
he advent of big data has ushered in a transformative era in the field of pharmacovigilance, shifting the focus from reactive drug safety monitoring to proactive, data-driven approaches. This paradigm shift is revolutionizing the way pharmaceutical companies and regulatory agencies detect, assess, and respond to adverse events and potential safety concerns associated with medications.
Pharmacovigilance and adr
The document discusses pharmacovigilance and adverse drug reactions (ADRs). It provides historical context on important events that increased focus on pharmacovigilance like the Thalidomide disaster. It describes the need for pharmacovigilance due to limitations of preclinical and clinical trials. It outlines the aims, methods like spontaneous reporting and causality assessment, and programs in India and by the WHO. It defines ADRs and provides classifications. In summary, the document overviews the importance and process of pharmacovigilance in monitoring drug safety post marketing.
Biomarkers in Clinical Trials: Enhancing Drug Development
Biomarkers play a crucial role in enhancing drug development by providing objective, measurable indicators of biological processes, disease progression, and treatment effects. These indicators can help researchers and pharmaceutical companies make informed decisions at various stages of clinical trials, leading to more efficient and successful drug development. Here's how biomarkers contribute to enhancing drug development in clinical trials:
Signal Detection and Their Assessment in Clinical Trial.
Signal detection in clinical trials refers to the process of identifying potential safety signals or new and potentially important information regarding adverse events associated with a drug or intervention. It involves analyzing data collected during the trial to detect any unexpected patterns, trends, or associations that may indicate a safety concern. Here are the key steps involved in signal detection and their assessment in clinical trials:
Data Collection:
Accurate and comprehensive data collection is essential for signal detection. This includes the collection of adverse event data, including the nature of the event, severity, timing, duration, and any associated factors. Other relevant data, such as patient demographics, concomitant medications, and medical history, may also be collected.
Data Cleaning and Preparation:
Data cleaning and preparation involve reviewing and validating the collected data to ensure accuracy, completeness, and consistency. This includes identifying and resolving missing, inconsistent, or erroneous data. Data coding and standardization may also be performed to facilitate analysis.
Data Exploration and Descriptive Analysis:
Initial exploratory data analysis is conducted to identify patterns, trends, or outliers in the collected data. This may involve the calculation of descriptive statistics, such as frequencies, proportions, and measures of central tendency, to summarize the adverse event data. Data visualization techniques, such as plots, graphs, or charts, may be used to aid in the identification of potential signals.
Statistical Methods:
Various statistical methods can be applied to detect potential signals in clinical trial data. These methods include:
Disproportionality Analysis: This method examines the frequency of specific adverse events in relation to the exposure to the drug or intervention compared to other drugs or interventions. Common disproportionality measures include reporting odds ratios (ROR) or information component (IC).
Time-to-Event Analysis: This analysis focuses on the time between drug exposure and the occurrence of adverse events. Methods such as Kaplan-Meier survival analysis or Cox proportional hazards models can be used to assess if there are any significant differences in event rates between treatment groups.
Comparative Analysis: Comparing adverse event rates between treatment groups or different patient populations can help identify potential signals. This may involve calculating incidence rates, relative risks, or odds ratios.
Sequential Monitoring: Sequential monitoring methods, such as the Poisson distribution or Bayesian approaches, can be employed to detect signals in ongoing trials by monitoring accumulating data over time.
Signal Assessment:
Once potential signals are identified, further assessment is conducted to evaluate the clinical relevance and validity of the signals.
What is clinical research
Clinical research is a systematic investigation that involves the study of human participants to evaluate the safety, efficacy, and effectiveness of medical treatments, drugs, devices, and interventions. The primary goal of clinical research is to generate robust and reliable evidence to inform healthcare decisions, improve patient care, and advance medical knowledge. It encompasses a wide range of activities and studies, including clinical trials, observational studies, and other research methodologies
Phases of clinical trials 1,2,3 &4
This document discusses the various phases of clinical trials for drug development. It begins with preclinical testing on animals. Next is the investigational new drug application (IND) to obtain approval for human testing. Clinical trials then proceed through four phases to evaluate a drug's safety, efficacy, and dosing in humans. Phase 1 involves initial safety and dosing tests on healthy volunteers. Phase 2 expands to more subjects to further assess safety and efficacy. Phase 3 involves large-scale trials to confirm effectiveness. After approval, Phase 4 involves post-marketing surveillance. The overall goal is to generate sufficient data to submit a new drug application (NDA) and gain regulatory approval to market a new pharmaceutical drug.
Integrated pharmacovigilance
Integrated pharmacovigilance refers to the comprehensive and coordinated approach of monitoring, assessing, and managing the safety of pharmaceutical products throughout their lifecycle. It involves the integration of various functions, processes, and stakeholders to ensure the continuous surveillance of the benefits and risks associated with medical products, such as drugs and medical devices. The goal of integrated pharmacovigilance is to enhance patient safety, improve decision-making, and facilitate efficient regulatory oversight.
Pharmacovigilance planning
Pharmacovigilance planning is a systematic approach to ensuring the safety of pharmaceutical products, including drugs and medical devices, once they are approved and available in the market. It involves creating strategies, processes, and systems to monitor, detect, assess, and prevent adverse effects or other drug-related problems throughout the product's lifecycle. The ultimate goal of pharmacovigilance planning is to protect patient safety and public health by minimizing risks associated with the use of medical products.
Phases of clinical trials
Clinical trial is a systematic investigation in human subjects for evaluating the safety & efficacy of any new drug.
Role of Drug Regulatory agencies in Clinical Research.
Drug regulatory agencies play a pivotal role in overseeing and regulating clinical research to ensure the safety, efficacy, and quality of pharmaceutical products. Their primary responsibility is to protect public health by evaluating the data generated from clinical trials and determining whether a drug can be approved for marketing and use in patients. Here are some key roles of drug regulatory agencies in clinical research:
Approval and Oversight of Clinical Trials: Regulatory agencies review and approve clinical trial protocols, ensuring that they adhere to ethical and scientific standards. They assess the design, methodology, and objectives of trials to ensure patient safety and the reliability of data generated.
Regulatory Guidance and Standards: These agencies provide guidance and establish regulations governing the conduct of clinical trials, including Good Clinical Practice (GCP) guidelines, which outline standards for trial design, conduct, monitoring, and reporting.
Review and Evaluation of Data: Regulatory agencies review the data collected from clinical trials to assess the safety and efficacy of investigational drugs. They evaluate study results, adverse events, and other relevant information to make informed decisions about drug approval.
Drug Approval and Labeling: Based on the evaluation of clinical trial data, regulatory agencies decide whether to approve a drug for marketing and use. They also determine the appropriate labeling, including indications, dosages, contraindications, and warnings, to ensure safe and effective use by healthcare professionals and patients.
Post-Marketing Surveillance: Regulatory agencies continue to monitor the safety and effectiveness of approved drugs through post-marketing surveillance programs. They collect and analyze real-world data on adverse events and drug utilization to identify potential risks and take appropriate regulatory actions if safety concerns arise.
Enforcement of Regulations: Regulatory agencies enforce compliance with regulatory requirements and take enforcement actions against sponsors, investigators, or manufacturers who fail to adhere to ethical or regulatory standards in clinical research.
International Collaboration: Many regulatory agencies collaborate with counterparts in other countries to harmonize regulatory standards, exchange information, and streamline the drug approval process, facilitating global drug development and access to new therapies.
Data Privacy and consent management .. .
Data privacy and consent management are critical aspects of ensuring that individuals' personal information is handled responsibly and ethically, particularly in healthcare settings where sensitive medical data is involved. Data privacy refers to the protection of personal information from unauthorized access, use, or disclosure, while consent management involves obtaining and managing individuals' permissions for the collection, storage, and processing of their data.
In healthcare, patients entrust providers with their sensitive medical information, expecting that it will be kept confidential and used only for legitimate purposes related to their care. Robust data privacy measures include encryption, access controls, and anonymization techniques to safeguard patient data from unauthorized access or breaches. Additionally, healthcare organizations must adhere to regulatory standards such as HIPAA in the United States or GDPR in the European Union, which outline specific requirements for the protection of patient information and impose penalties for non-compliance.
Consent management plays a crucial role in ensuring that individuals have control over how their data is used. Patients should be informed about the purposes for which their data will be collected and processed, as well as any potential risks or benefits associated with its use. Obtaining informed consent involves providing individuals with clear and transparent information about their privacy rights and giving them the opportunity to consent to or decline the use of their data for specific purposes. Consent management systems help healthcare organizations track and manage patients' consent preferences, ensuring that data is used in accordance with their wishes and legal requirements.
Effective data privacy and consent management practices not only protect individuals' privacy rights but also foster trust and transparency in healthcare relationships. By implementing robust security measures, respecting patients' autonomy, and promoting informed decision-making, healthcare organizations can uphold the principles of data privacy and consent while leveraging data responsibly to improve patient care and outcomes.
More Related Content
Similar to Post-Marketing Safety Surveillance: Detecting Adverse Events
The impact of real world data in pharmacovilgilance and regulatory decision m...
Real-world data (RWD) has revolutionized the field of pharmacovigilance and regulatory decision-making. While clinical trials provide valuable insights into the safety and efficacy of medications, RWD offers a comprehensive view of a drug's performance in real-world settings. In this blog post, we will explore the significant impact of RWD in pharmacovigilance and how it has transformed the way regulatory decisions are made. We will discuss the benefits of utilizing RWD, the challenges associated with its implementation, and its potential to improve patient safety and healthcare outcomes.
Phase 3
This document provides an overview of phase 3 clinical trials. Phase 3 trials involve large randomized controlled trials of up to 3000 patients to generate statistically significant data on a drug's safety and efficacy in different patient populations. The objectives are to demonstrate therapeutic efficacy and safety/tolerability in a representative sample. Results are submitted to regulatory agencies for marketing approval. Challenges include long duration, large sample sizes, high costs, and coordinating multiple study sites. If approved, the new drug application process requires submission of all safety, efficacy and manufacturing data to the regulatory agency for review and potential approval.
Canada’s Orphan Drug Regulatory Framework & panCanadian Access to Rare Diseas...
Canada’s Orphan Drug Regulatory Framework & panCanadian Access to Rare Diseas...Canadian Organization for Rare Disorders
The document discusses Canada's orphan drug regulatory framework and opportunities to improve access to rare disease drugs across Canada. It advocates for a life-cycle approach and managed access schemes where drugs are approved with evidence collection requirements. Traditional health technology assessment limits orphan drug access by rejecting drugs that are not cost-effective based on small clinical trials. The document recommends performance-based managed access programs with national guidelines and risk-sharing between provinces, patients, and companies to improve access while collecting long-term evidence on benefits, harms, and costs.Patient centered Pharmacovigilance .. .
Patient-centered pharmacovigilance represents a pivotal shift in the landscape of healthcare, emphasizing the active involvement of patients in the monitoring and reporting of adverse drug reactions. Unlike traditional pharmacovigilance, which primarily relies on healthcare professionals to identify and document adverse events, this approach recognizes patients as critical stakeholders in ensuring medication safety. By empowering patients to share their experiences, concerns, and observations regarding medication effects, whether positive or negative, healthcare systems can gain a comprehensive understanding of drug safety and efficacy in real-world settings. Patient-centered pharmacovigilance fosters a collaborative partnership between patients, healthcare providers, and regulatory agencies, promoting transparency, accountability, and ultimately, better patient outcomes. Through increased patient engagement and the utilization of patient-reported data, this approach enables healthcare systems to identify potential safety issues earlier, tailor treatment strategies to individual needs, and enhance overall drug safety surveillance efforts.
Signal detection and their assessment in clinical trials
Signal detection and assessment in clinical trials refer to the process of identifying potential safety concerns or unexpected events related to a study intervention, treatment, or medical product. It involves monitoring and analyzing data collected during the trial to detect any patterns, trends, or signals that might indicate a safety issue. This proactive approach helps ensure the safety of participants and enables timely interventions if necessary.
Here's an overview of the process of signal detection and assessment in clinical trials:
Pharmacovigilance Training in Oracle Argus Safety Database
Pharmacovigilance training is essential for pharmaceutical and healthcare organizations to ensure your operations comply with the latest regulatory guidelines, laws and standards. At Gratisol Labs, we provide industry-leading pharmacovigilance training courses with hands on experience on safety databases & medical coding that cover the basics of Pharmacovigilance till advanced drug safety topics, the regulatory requirements of pharmacovigilance, signal detection, and pharmacovigilance audits are covered in the complete Gratisol Labs Pharmacovigilance Training Programme.
Vaccine Safety Monitoring: Pharmacovigilance Strategies
Vaccine safety monitoring is a critical aspect of pharmacovigilance, particularly given the widespread use of vaccines to prevent infectious diseases. Robust surveillance systems are essential to detect and assess any potential adverse events following vaccination. Here are some key pharmacovigilance strategies employed for vaccine safety monitoring:
Passive Surveillance Systems:
Passive surveillance systems rely on healthcare providers, patients, and other stakeholders to voluntarily report adverse events following vaccination. These reports are collected in databases such as the Vaccine Adverse Event Reporting System (VAERS) in the United States or the Vaccine Adverse Event Surveillance System (VAESS) in other countries. While these systems are valuable for signal detection, they may suffer from underreporting and reporting bias.
Active Surveillance Systems:
Active surveillance involves proactively monitoring a defined population for adverse events following vaccination. This can be done through electronic health records (EHRs), claims databases, and other health data sources. The Vaccine Safety Datalink (VSD) in the United States is an example of an active surveillance system that uses large databases to continuously monitor vaccine safety.
Enhanced Surveillance and Cohort Studies:
Enhanced surveillance involves more intensive monitoring of a specific population or group of interest. Cohort studies are prospective studies that follow a group of vaccinated individuals over time to assess vaccine safety. These studies provide more detailed and controlled data compared to passive or active surveillance.
Comparative Effectiveness Research:
Comparative effectiveness research compares the safety of different vaccines or vaccination schedules. By analyzing large datasets, researchers can evaluate the relative risks and benefits of vaccines and identify any safety concerns.
Signal Detection and Analysis:
Data mining and statistical techniques are used to identify potential safety signals from adverse event reports. Signals are further investigated through in-depth analysis to determine if there is a causal relationship between the vaccine and the adverse event.
Causality Assessment:
Similar to general pharmacovigilance, causality assessment methods (such as the Naranjo Algorithm, WHO-UMC System, and Bayesian methods) are used to evaluate the likelihood of a causal relationship between a vaccine and an adverse event.
Risk Communication and Public Awareness:
Effective communication strategies are crucial to ensure that healthcare providers and the public are informed about vaccine safety. This involves providing clear and accurate information about potential risks and benefits.
TGA presentation: Postmarket Monitoring
View this presentation for information on:
what postmarket monitoring is and why it is important
tools used in postmarket monitoring, including risk management plans
managing risk and adverse events
the TGA's early warning system and recall actions.
POST MARKETING SURVILLANCE
This document discusses post-marketing surveillance of pharmaceuticals. Post-marketing surveillance involves monitoring drugs after they are approved for public use to identify safety risks. It can involve controlled clinical trials, spontaneous reporting of adverse events, cohort studies, and case-control studies. The FDA Adverse Event Reporting System collects over a million reports annually to detect unknown risks and safety issues not found in clinical trials. Post-marketing surveillance is important for monitoring long-term effects and risks in broader patient populations than clinical trials.
postmarketing surviellance,,outsourcing of BA ,BE , CRO.
This document provides an overview of post-marketing surveillance, outsourcing of bioavailability and bioequivalence studies to contract research organizations. It discusses the need for post-marketing surveillance to identify rare or long-term adverse drug reactions not seen in clinical trials. Methods for post-marketing surveillance include controlled trials, spontaneous reporting, cohort and case-control studies. Outsourcing bioavailability and bioequivalence studies to CROs can help reduce costs and improve resource efficiency for pharmaceutical companies.
Pharmacovigilance in Special Populations: Considerations for Pediatric and Ge...
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. When it comes to special populations, such as pediatric and geriatric patients, there are specific considerations that need to be taken into account in pharmacovigilance efforts. Here are some key points regarding pharmacovigilance in these population
How Big Data Transforms Reactive Drug Safety to Proactive Pharmacovigilance
he advent of big data has ushered in a transformative era in the field of pharmacovigilance, shifting the focus from reactive drug safety monitoring to proactive, data-driven approaches. This paradigm shift is revolutionizing the way pharmaceutical companies and regulatory agencies detect, assess, and respond to adverse events and potential safety concerns associated with medications.
Pharmacovigilance and adr
The document discusses pharmacovigilance and adverse drug reactions (ADRs). It provides historical context on important events that increased focus on pharmacovigilance like the Thalidomide disaster. It describes the need for pharmacovigilance due to limitations of preclinical and clinical trials. It outlines the aims, methods like spontaneous reporting and causality assessment, and programs in India and by the WHO. It defines ADRs and provides classifications. In summary, the document overviews the importance and process of pharmacovigilance in monitoring drug safety post marketing.
Biomarkers in Clinical Trials: Enhancing Drug Development
Biomarkers play a crucial role in enhancing drug development by providing objective, measurable indicators of biological processes, disease progression, and treatment effects. These indicators can help researchers and pharmaceutical companies make informed decisions at various stages of clinical trials, leading to more efficient and successful drug development. Here's how biomarkers contribute to enhancing drug development in clinical trials:
Signal Detection and Their Assessment in Clinical Trial.
Signal detection in clinical trials refers to the process of identifying potential safety signals or new and potentially important information regarding adverse events associated with a drug or intervention. It involves analyzing data collected during the trial to detect any unexpected patterns, trends, or associations that may indicate a safety concern. Here are the key steps involved in signal detection and their assessment in clinical trials:
Data Collection:
Accurate and comprehensive data collection is essential for signal detection. This includes the collection of adverse event data, including the nature of the event, severity, timing, duration, and any associated factors. Other relevant data, such as patient demographics, concomitant medications, and medical history, may also be collected.
Data Cleaning and Preparation:
Data cleaning and preparation involve reviewing and validating the collected data to ensure accuracy, completeness, and consistency. This includes identifying and resolving missing, inconsistent, or erroneous data. Data coding and standardization may also be performed to facilitate analysis.
Data Exploration and Descriptive Analysis:
Initial exploratory data analysis is conducted to identify patterns, trends, or outliers in the collected data. This may involve the calculation of descriptive statistics, such as frequencies, proportions, and measures of central tendency, to summarize the adverse event data. Data visualization techniques, such as plots, graphs, or charts, may be used to aid in the identification of potential signals.
Statistical Methods:
Various statistical methods can be applied to detect potential signals in clinical trial data. These methods include:
Disproportionality Analysis: This method examines the frequency of specific adverse events in relation to the exposure to the drug or intervention compared to other drugs or interventions. Common disproportionality measures include reporting odds ratios (ROR) or information component (IC).
Time-to-Event Analysis: This analysis focuses on the time between drug exposure and the occurrence of adverse events. Methods such as Kaplan-Meier survival analysis or Cox proportional hazards models can be used to assess if there are any significant differences in event rates between treatment groups.
Comparative Analysis: Comparing adverse event rates between treatment groups or different patient populations can help identify potential signals. This may involve calculating incidence rates, relative risks, or odds ratios.
Sequential Monitoring: Sequential monitoring methods, such as the Poisson distribution or Bayesian approaches, can be employed to detect signals in ongoing trials by monitoring accumulating data over time.
Signal Assessment:
Once potential signals are identified, further assessment is conducted to evaluate the clinical relevance and validity of the signals.
What is clinical research
Clinical research is a systematic investigation that involves the study of human participants to evaluate the safety, efficacy, and effectiveness of medical treatments, drugs, devices, and interventions. The primary goal of clinical research is to generate robust and reliable evidence to inform healthcare decisions, improve patient care, and advance medical knowledge. It encompasses a wide range of activities and studies, including clinical trials, observational studies, and other research methodologies
Phases of clinical trials 1,2,3 &4
This document discusses the various phases of clinical trials for drug development. It begins with preclinical testing on animals. Next is the investigational new drug application (IND) to obtain approval for human testing. Clinical trials then proceed through four phases to evaluate a drug's safety, efficacy, and dosing in humans. Phase 1 involves initial safety and dosing tests on healthy volunteers. Phase 2 expands to more subjects to further assess safety and efficacy. Phase 3 involves large-scale trials to confirm effectiveness. After approval, Phase 4 involves post-marketing surveillance. The overall goal is to generate sufficient data to submit a new drug application (NDA) and gain regulatory approval to market a new pharmaceutical drug.
Integrated pharmacovigilance
Integrated pharmacovigilance refers to the comprehensive and coordinated approach of monitoring, assessing, and managing the safety of pharmaceutical products throughout their lifecycle. It involves the integration of various functions, processes, and stakeholders to ensure the continuous surveillance of the benefits and risks associated with medical products, such as drugs and medical devices. The goal of integrated pharmacovigilance is to enhance patient safety, improve decision-making, and facilitate efficient regulatory oversight.
Pharmacovigilance planning
Pharmacovigilance planning is a systematic approach to ensuring the safety of pharmaceutical products, including drugs and medical devices, once they are approved and available in the market. It involves creating strategies, processes, and systems to monitor, detect, assess, and prevent adverse effects or other drug-related problems throughout the product's lifecycle. The ultimate goal of pharmacovigilance planning is to protect patient safety and public health by minimizing risks associated with the use of medical products.
Phases of clinical trials
Clinical trial is a systematic investigation in human subjects for evaluating the safety & efficacy of any new drug.
Similar to Post-Marketing Safety Surveillance: Detecting Adverse Events (20)
The impact of real world data in pharmacovilgilance and regulatory decision m...
The impact of real world data in pharmacovilgilance and regulatory decision m...
Canada’s Orphan Drug Regulatory Framework & panCanadian Access to Rare Diseas...
Canada’s Orphan Drug Regulatory Framework & panCanadian Access to Rare Diseas...
Signal detection and their assessment in clinical trials
Signal detection and their assessment in clinical trials
Pharmacovigilance Training in Oracle Argus Safety Database
Pharmacovigilance Training in Oracle Argus Safety Database
Vaccine Safety Monitoring: Pharmacovigilance Strategies
Vaccine Safety Monitoring: Pharmacovigilance Strategies
postmarketing surviellance,,outsourcing of BA ,BE , CRO.
postmarketing surviellance,,outsourcing of BA ,BE , CRO.
Pharmacovigilance in Special Populations: Considerations for Pediatric and Ge...
Pharmacovigilance in Special Populations: Considerations for Pediatric and Ge...
How Big Data Transforms Reactive Drug Safety to Proactive Pharmacovigilance
How Big Data Transforms Reactive Drug Safety to Proactive Pharmacovigilance
Biomarkers in Clinical Trials: Enhancing Drug Development
Biomarkers in Clinical Trials: Enhancing Drug Development
Signal Detection and Their Assessment in Clinical Trial.
Signal Detection and Their Assessment in Clinical Trial.
More from ClinosolIndia
Role of Drug Regulatory agencies in Clinical Research.
Drug regulatory agencies play a pivotal role in overseeing and regulating clinical research to ensure the safety, efficacy, and quality of pharmaceutical products. Their primary responsibility is to protect public health by evaluating the data generated from clinical trials and determining whether a drug can be approved for marketing and use in patients. Here are some key roles of drug regulatory agencies in clinical research:
Approval and Oversight of Clinical Trials: Regulatory agencies review and approve clinical trial protocols, ensuring that they adhere to ethical and scientific standards. They assess the design, methodology, and objectives of trials to ensure patient safety and the reliability of data generated.
Regulatory Guidance and Standards: These agencies provide guidance and establish regulations governing the conduct of clinical trials, including Good Clinical Practice (GCP) guidelines, which outline standards for trial design, conduct, monitoring, and reporting.
Review and Evaluation of Data: Regulatory agencies review the data collected from clinical trials to assess the safety and efficacy of investigational drugs. They evaluate study results, adverse events, and other relevant information to make informed decisions about drug approval.
Drug Approval and Labeling: Based on the evaluation of clinical trial data, regulatory agencies decide whether to approve a drug for marketing and use. They also determine the appropriate labeling, including indications, dosages, contraindications, and warnings, to ensure safe and effective use by healthcare professionals and patients.
Post-Marketing Surveillance: Regulatory agencies continue to monitor the safety and effectiveness of approved drugs through post-marketing surveillance programs. They collect and analyze real-world data on adverse events and drug utilization to identify potential risks and take appropriate regulatory actions if safety concerns arise.
Enforcement of Regulations: Regulatory agencies enforce compliance with regulatory requirements and take enforcement actions against sponsors, investigators, or manufacturers who fail to adhere to ethical or regulatory standards in clinical research.
International Collaboration: Many regulatory agencies collaborate with counterparts in other countries to harmonize regulatory standards, exchange information, and streamline the drug approval process, facilitating global drug development and access to new therapies.
Data Privacy and consent management .. .
Data privacy and consent management are critical aspects of ensuring that individuals' personal information is handled responsibly and ethically, particularly in healthcare settings where sensitive medical data is involved. Data privacy refers to the protection of personal information from unauthorized access, use, or disclosure, while consent management involves obtaining and managing individuals' permissions for the collection, storage, and processing of their data.
In healthcare, patients entrust providers with their sensitive medical information, expecting that it will be kept confidential and used only for legitimate purposes related to their care. Robust data privacy measures include encryption, access controls, and anonymization techniques to safeguard patient data from unauthorized access or breaches. Additionally, healthcare organizations must adhere to regulatory standards such as HIPAA in the United States or GDPR in the European Union, which outline specific requirements for the protection of patient information and impose penalties for non-compliance.
Consent management plays a crucial role in ensuring that individuals have control over how their data is used. Patients should be informed about the purposes for which their data will be collected and processed, as well as any potential risks or benefits associated with its use. Obtaining informed consent involves providing individuals with clear and transparent information about their privacy rights and giving them the opportunity to consent to or decline the use of their data for specific purposes. Consent management systems help healthcare organizations track and manage patients' consent preferences, ensuring that data is used in accordance with their wishes and legal requirements.
Effective data privacy and consent management practices not only protect individuals' privacy rights but also foster trust and transparency in healthcare relationships. By implementing robust security measures, respecting patients' autonomy, and promoting informed decision-making, healthcare organizations can uphold the principles of data privacy and consent while leveraging data responsibly to improve patient care and outcomes.
Clinical data security and Integrity in Clinical Research
Clinical data security and integrity are paramount in maintaining patient confidentiality, protecting sensitive medical information, and ensuring the reliability of healthcare data. Security measures encompass various strategies and technologies aimed at safeguarding clinical data from unauthorized access, breaches, or manipulation.
Encryption techniques, access controls, and secure authentication mechanisms are commonly employed to restrict access to patient records and prevent unauthorized individuals from viewing or altering sensitive data. Additionally, robust network security protocols, such as firewalls and intrusion detection systems, help safeguard against external threats and cyberattacks targeting healthcare systems.
Pharmacovigilance in Patriatics and Geriatrics
Pharmacovigilance in pediatrics and geriatrics is of paramount importance due to the unique physiological and pharmacokinetic characteristics of these populations. In pediatrics, factors such as rapid growth, organ maturation, and differences in drug metabolism can influence the safety and efficacy of medications. Therefore, monitoring for adverse drug reactions (ADRs), including both known and unexpected effects, is crucial in ensuring the safe use of drugs in children. Additionally, since pediatric patients often receive off-label or unlicensed medications due to limited clinical trials in this population, pharmacovigilance efforts play a critical role in gathering real-world data to inform pediatric drug use.
Presenting- Signal mining in Pharmacovigilance
Signal mining in pharmacovigilance involves the systematic analysis of large datasets to identify potential safety signals associated with medications. It encompasses a variety of computational and statistical methods aimed at detecting patterns or trends that may indicate previously unrecognized adverse drug reactions (ADRs). Signal mining relies on data from sources such as spontaneous reporting systems, electronic health records, clinical trials, and medical literature. Advanced algorithms and data mining techniques, including disproportionality analysis, Bayesian data mining, and machine learning, are employed to sift through vast amounts of data to uncover potential signals of concern. These signals are then subjected to further evaluation to determine their clinical relevance and potential impact on patient safety. By leveraging the power of big data and analytics, signal mining plays a crucial role in enhancing pharmacovigilance efforts, enabling proactive identification and mitigation of medication-related risks, and ultimately contributing to improved patient care and drug safety.
Introduction to Blogs, Presentations and Review Articles- Noorush Shifa Nizami
Blogs, presentations, and review articles stand as dynamic mediums, each with its unique power to engage, inform, and influence. Blogs, the conversational storytellers; presentations, the visual orchestrators; and review articles, the comprehensive knowledge curators, collectively play pivotal roles in shaping how we share, learn, and explore diverse subjects. This exploration delves into the distinct characteristics and purposes of these forms of communication, unveiling the art of effective expression and knowledge sharing in the digital age.
Patient-Centric Approaches in Precision Medicine Trials: Strategies for Success
Precision medicine, with its focus on tailoring medical treatment to the individual characteristics of each patient, has ushered in a new era in healthcare. Within this paradigm, clinical trials play a pivotal role in testing and validating targeted therapies. This article explores the importance of adopting patient-centric approaches in precision medicine trials and outlines strategies to enhance their success. By prioritizing patient engagement, leveraging digital technologies, and fostering collaborative partnerships, precision medicine trials can not only advance scientific understanding but also ensure that patient perspectives and experiences are integral to the research process.
Collaborative Initiatives: How Patient Advocacy Groups Contribute to the Succ...
Collaborative initiatives involving patient advocacy groups play a crucial role in advancing the success of precision medicine. Precision medicine, also known as personalized medicine, tailors medical treatment and interventions to the characteristics of each patient, considering factors such as genetic makeup, lifestyle, and environment. Patient advocacy groups contribute to the success of precision medicine in several ways:
Raising Awareness and Education:
Patient advocacy groups are instrumental in raising awareness about precision medicine among their communities.
They provide education and resources to patients, caregivers, and the general public, promoting a better understanding of the benefits and implications of precision medicine.
Patient Empowerment:
Advocacy groups empower patients by providing them with information about their conditions and treatment options.
They help patients understand the importance of participating in precision medicine initiatives, including clinical trials and genetic testing.
Supporting Research and Development:
Patient advocacy groups often collaborate with researchers and industry stakeholders to support the development of targeted therapies and diagnostics.
By actively participating in research initiatives, advocacy groups contribute to the identification of genetic markers, biomarkers, and other factors that influence treatment response.
Influencing Policy and Regulation:
Advocacy groups advocate for policies that support the advancement of precision medicine.
They work to ensure that regulations promote patient access to personalized treatments and protect patient rights, privacy, and data security.
Fostering Collaboration:
Patient advocacy groups facilitate collaboration among patients, researchers, healthcare providers, and industry partners.
They create platforms for sharing information, experiences, and best practices, fostering a collaborative environment that accelerates progress in precision medicine.
Clinical Trial Recruitment:
Advocacy groups play a crucial role in recruiting patients for clinical trials related to precision medicine.
Their engagement helps ensure diverse and representative participant populations, leading to more robust and applicable research outcomes.
Feedback and Patient-Centric Approaches:
Advocacy groups provide valuable feedback on the patient experience, preferences, and priorities.
This patient-centric approach helps researchers and healthcare professionals tailor precision medicine strategies to better meet the needs and expectations of the individuals they serve.
Championing Access to Treatments:
Patient advocacy groups work to improve patient access to precision medicine treatments.
They advocate for affordable and equitable access to innovative therapies, ensuring that the benefits of precision medicine are accessible to a broader population.
In summary, patient advocacy groups play a multifaceted role in advancing precision medicine by fostering awareness,
Ethical Dilemmas in Precision Medicine: Navigating the Intersection of Scienc...
The Ethical dilemmas in precision medicine arise from balancing the potential benefits of tailored treatments with concerns about privacy, consent, equity, and the implications of genetic information. These Dilemmas include issues around informed consent for data sharing, ensuring equitable access to precision medicine technologies, and safeguarding against discrimination based on Information. The potential for misuse or unintended consequences further complicate the ethical landscape of precision medicine. The Precision medicine widely used in Data Integration, Biomarkers, Targeted Therapies, predictive modeling, Clinical Decision Support. Precision Medicine improves the Patient outcomes, enhancing treatment efficacy, and reducing healthcare costs by minimizing trial and error in treatment selection. The precision medicine also raises Ethical legal and social complications related to data privacy, consent and equitable access and the potential for Discrimination based on information.
Regulatory Considerations in Precision Medicine: Navigating the Approval Process
Precision medicine, with its focus on tailoring medical treatments to individual characteristics, presents unique regulatory challenges in the drug development and approval process. This ppt delves into the regulatory considerations associated with precision medicine, exploring the key aspects that pharmaceutical and biotechnology companies need to navigate
Emerging Technologies and Tools in Precision Medicine Research
Precision medicine has witnessed significant advancements with the integration of emerging technologies and innovative tools. This abstract explores the current landscape of precision medicine research, focusing on the role of cutting-edge technologies and tools in revolutionizing healthcare approaches.
Precision Medicine in Action: Case Studies and Success Stories
Precision medicine, an innovative approach tailoring medical treatment to individual characteristics, holds great promise for improved patient outcomes. In this paradigm, pharmacovigilance plays a crucial role in monitoring and ensuring the safety of personalized treatments. The integration of big data and artificial intelligence (AI) into pharmacovigilance practices becomes paramount for handling the complexities of individualized therapies and identifying potential safety concerns. This article explores the synergies between big data, AI, and pharmacovigilance in the context of precision medicine.
Harnessing Big Data and Artificial Intelligence for Pharmacovigilance in Prec...
Precision medicine, an innovative approach tailoring medical treatment to individual characteristics, holds great promise for improved patient outcomes. In this paradigm, pharmacovigilance plays a crucial role in monitoring and ensuring the safety of personalized treatments. The integration of big data and artificial intelligence (AI) into pharmacovigilance practices becomes paramount for handling the complexities of individualized therapies and identifying potential safety concerns. This article explores the synergies between big data, AI, and pharmacovigilance in the context of precision medicine.
Integration of Clinical Trial Systems: Enhancing Collaboration and Efficiency
Clinical trials are complex endeavors that involve numerous stakeholders, vast datasets, and intricate processes. To streamline operations, enhance collaboration, and improve efficiency, the integration of clinical trial systems has emerged as a pivotal solution. This strategic approach involves connecting various components, such as electronic data capture (EDC) systems, clinical trial management systems (CTMS), and electronic health records (EHR), fostering a cohesive ecosystem that accelerates the pace of research and ensures data accuracy.
Pharmacovigilance (PV) Companies: Ensuring Drug Safety in Personalized Treatm...
Pharmacovigilance, a critical component of the healthcare and pharmaceutical industry, plays a pivotal role in monitoring and ensuring the safety of drugs. As personalized treatment approaches gain prominence, the responsibilities of PV companies become even more significant. This article explores the key functions of pharmacovigilance companies in the context of personalized medicine, focusing on their role in ensuring drug safety and mitigating potential risks associated with tailored therapeutic interventions.
Adoptive Design: Optimizing Clinical Trial Strategies for Precision Medicine
Clinical trials play a pivotal role in advancing medical research and ensuring the efficacy of new treatments. In the context of precision medicine, where therapies are tailored to individual characteristics, adaptive design emerges as a powerful strategy to optimize clinical trial outcomes. This approach deviates from traditional fixed trial designs, allowing for modifications based on accumulating data, thus enhancing efficiency, flexibility, and the likelihood of success in precision medicine endeavors.
Artificial Intelligence In Clinical Trial
Clinical trials are a cornerstone of medical research, paving the way for new treatments and advancements in healthcare. In recent years, Artificial Intelligence (AI) has emerged as a transformative force, reshaping the landscape of clinical trials. This article explores the various ways in which AI is revolutionizing the design, execution, and analysis of clinical trials.
Emerging Technologies Shaping the Future of Precision Medicine
Precision medicine, with its focus on tailoring healthcare interventions to individual characteristics, is undergoing a transformative evolution propelled by emerging technologies. From advanced genomic tools to artificial intelligence, these technologies are revolutionizing our ability to understand, diagnose, and treat diseases at an unprecedented level of specificity. This article explores the key emerging technologies shaping the future of precision medicine.
Innovations in Liquid Biopsies for Precision Cancer Diagnosis
Precision medicine, with its focus on tailoring medical interventions to individual characteristics, benefits significantly from the integration of machine learning (ML) algorithms for predictive analytics. These algorithms analyze complex datasets, identify patterns, and generate predictions that inform personalized treatment strategies. This article explores the diverse applications of ML in precision medicine, highlighting the key algorithms driving predictive analytics in this transformative field.
Machine Learning Algorithms for Predictive Analytics in Precision Medicine
The integration of machine learning algorithms for predictive analytics in precision medicine represents a powerful tool for extracting meaningful insights from diverse and complex datasets. As the field continues to evolve, these algorithms play a crucial role in advancing our understanding of individualized treatment strategies, improving patient outcomes, and ultimately shaping the future of personalized healthcare.
More from ClinosolIndia (20)
Role of Drug Regulatory agencies in Clinical Research.
Role of Drug Regulatory agencies in Clinical Research.
Clinical data security and Integrity in Clinical Research
Clinical data security and Integrity in Clinical Research
Introduction to Blogs, Presentations and Review Articles- Noorush Shifa Nizami
Introduction to Blogs, Presentations and Review Articles- Noorush Shifa Nizami
Patient-Centric Approaches in Precision Medicine Trials: Strategies for Success
Patient-Centric Approaches in Precision Medicine Trials: Strategies for Success
Collaborative Initiatives: How Patient Advocacy Groups Contribute to the Succ...
Collaborative Initiatives: How Patient Advocacy Groups Contribute to the Succ...
Ethical Dilemmas in Precision Medicine: Navigating the Intersection of Scienc...
Ethical Dilemmas in Precision Medicine: Navigating the Intersection of Scienc...
Regulatory Considerations in Precision Medicine: Navigating the Approval Process
Regulatory Considerations in Precision Medicine: Navigating the Approval Process
Emerging Technologies and Tools in Precision Medicine Research
Emerging Technologies and Tools in Precision Medicine Research
Precision Medicine in Action: Case Studies and Success Stories
Precision Medicine in Action: Case Studies and Success Stories
Harnessing Big Data and Artificial Intelligence for Pharmacovigilance in Prec...
Harnessing Big Data and Artificial Intelligence for Pharmacovigilance in Prec...
Integration of Clinical Trial Systems: Enhancing Collaboration and Efficiency
Integration of Clinical Trial Systems: Enhancing Collaboration and Efficiency
Pharmacovigilance (PV) Companies: Ensuring Drug Safety in Personalized Treatm...
Pharmacovigilance (PV) Companies: Ensuring Drug Safety in Personalized Treatm...
Adoptive Design: Optimizing Clinical Trial Strategies for Precision Medicine
Adoptive Design: Optimizing Clinical Trial Strategies for Precision Medicine
Emerging Technologies Shaping the Future of Precision Medicine
Emerging Technologies Shaping the Future of Precision Medicine
Innovations in Liquid Biopsies for Precision Cancer Diagnosis
Innovations in Liquid Biopsies for Precision Cancer Diagnosis
Machine Learning Algorithms for Predictive Analytics in Precision Medicine
Machine Learning Algorithms for Predictive Analytics in Precision Medicine
Recently uploaded
Does Over-Masturbation Contribute to Chronic Prostatitis.pptx
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by Stamler, Verified Chapters 1 - 33, Complete Newest Version Community Health Nursing A Canadian Perspective, 5th Edition by Stamler, Verified Chapters 1 - 33, Complete Newest Version Community Health Nursing A Canadian Perspective, 5th Edition by Stamler Community Health Nursing A Canadian Perspective, 5th Edition TEST BANK by Stamler Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Pdf Chapters Download Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Pdf Download Stuvia Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Study Guide Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Ebook Download Stuvia Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Questions and Answers Quizlet Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Studocu Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Quizlet Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Pdf Chapters Download Community Health Nursing A Canadian Perspective, 5th Edition Pdf Download Course Hero Community Health Nursing A Canadian Perspective, 5th Edition Answers Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Ebook Download Course hero Community Health Nursing A Canadian Perspective, 5th Edition Questions and Answers Community Health Nursing A Canadian Perspective, 5th Edition Studocu Community Health Nursing A Canadian Perspective, 5th Edition Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Pdf Chapters Download Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Pdf Download Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Study Guide Questions and Answers Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Ebook Download Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Questions Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Studocu Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Stuvia
Top Effective Soaps for Fungal Skin Infections in India
Swisschem Dermacare has mentioned the List of The Best Antifungal Soap In India 2022. All of these soaps are trusted by various Dermatology Experts.
Histololgy of Female Reproductive System.pptx
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
All info about Diabetes and how to control it.
One health condition that is becoming more common day by day is diabetes.
According to research conducted by the National Family Health Survey of India, diabetic cases show a projection which might increase to 10.4% by 2030.
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotes
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
vonoprazan A novel drug for GERD presentation
Vonoprazan, a new potassium acid channel blocker used in the conditions of GERD and gastric ulcer, duodenal ulcer ....
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Efficacy of Avartana Sneha in Ayurveda
Avartana Sneha is a unique method of Preparation of Sneha Kalpana in Ayurveda, mainly it is indicated for the Vataja rogas.
The Electrocardiogram - Physiologic Principles
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Artificial Intelligence Symposium (THAIS)
Artificial Intelligence Symposium (THAIS). Parc Taulí. Sabadell
Recently uploaded (20)
Does Over-Masturbation Contribute to Chronic Prostatitis.pptx
Does Over-Masturbation Contribute to Chronic Prostatitis.pptx
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...
Tests for analysis of different pharmaceutical.pptx
Tests for analysis of different pharmaceutical.pptx
Top Effective Soaps for Fungal Skin Infections in India
Top Effective Soaps for Fungal Skin Infections in India
Vestibulocochlear Nerve by Dr. Rabia Inam Gandapore.pptx
Vestibulocochlear Nerve by Dr. Rabia Inam Gandapore.pptx
Ear and its clinical correlations By Dr. Rabia Inam Gandapore.pptx
Ear and its clinical correlations By Dr. Rabia Inam Gandapore.pptx
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotes
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotes
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...
Post-Marketing Safety Surveillance: Detecting Adverse Events
- 1. Welcome POST MARKETING SAFETY SURVEILLANCE : DETECTING ADVERSE EVENTS Tejasri Namana Pharm D 126/072023 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 1
- 2. Index Phases of Clinical Trials Introduction Need of PMS Limitations of Pre-marketing Clinical Trials Benefits of PMS Adverse Events Sources Types of PMS studies Outcomes Conclusion 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 2
- 3. Phases of Clinical Trials Phase 1 : Micro dosing Phase 2 : First in patient -dose, dosage form Phase 3 : Efficacy, ADRs, Phase 4 : Post Marketing Surveillance (Evaluation in the real clinical setting) 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 3
- 4. Introduction Post Marketing Surveillance/PMS is the act of monitoring the safety of a pharmaceutical drug/ medical device after it has been released in the market. Safety surveillance is designed to detect any rare or long term adverse effects ina much larger patient population over a longer time period than was possible during phase I-III trials. It is an important part of science of Pharmacovigilance Safety Surveillance.PMS gives more realistic results as they occur in a more natural setting and afford evidence to safeguard or enhance the safety of approved. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 4
- 5. Need PMS study is a non-interventional study requested by regulatory authorities to verify the safety, tolerability & effectiveness of a marketed drug in a particular population per the locally aproved label. Phase IV trials involve the saftey surveillance & ongoing technical support of a drug after it receives permission to be sold These may be required by regulatory authorities or may be undertaken by the sponsoring company for competitive or other reasons 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 5
- 6. Limitations of Premarketing Clinical Trials • The safety and efficacy evaluations of any new medicinal product via clinical trials will provide only limited information on rare ADRs • Limited variety of conditions, described as the ‘five toos: too few, too simple, too narrow, too median-aged and too brief’, referring to the narrow patient selection criteria and sample size along with the short duration of clinical studies 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 6
- 7. Benefits of PMS • Safety monitoring is just one form of post-PMS • Ensures that information is collected in a varied spectrum of patients • PMS studies exemplify the differnce between efficacy & effectiveness • Discovering ‘rare’ (1 in 1000) and ‘very rare’ (1 in 10,000) is possible only in post marketing trials 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 7
- 8. Adverse Events • Adverse events are undesirable experiences associated with the use of a medical product. In the regulatory setting, adverse events are categorized as adverse drug events(ADEs) & a subset of ADE. • ADE - Unfavourable & unintended response to a drug, whether or not cosidered related to the product. It includes medical errors & adverse drug reactions • ADR - Noxoious & unintended response to a medicinal product if a medicine properly prescribed & administered 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 8
- 9. Sources Expert user groups Customer surveys Customer complaints & warranty claims Literature reviews Device tracking /implant registries User reaction during training programmes Media 9 www.clinosol.com | follow us on social media @clinosolresearch
- 10. Types of PMS studies 1. Controlled clinical trials Control refers to strict adherence to the protocols, the purpose of which is to reduce the variability of many factors & biases that might influence the trials. They are often costly 2. Spontaneous/voluntary reporting of cases A communication from an individual to a company or regulatory authority which describes a suspected adverse events But the actual incidence of adverse drug reaction cannot be determined through spontaneous reporting 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 10
- 11. Types of PMS studies 3. Cohort studies A cohort group is one into which patients are entered according to their exposure status 4. Case control studies It involves assembling of subjects in groups based on the outcome found in those subjects 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 11
- 12. Outcomes • Signals • Pharmacoepidemiological information • Need for controlled studies • Labelling changes with modified undesirable effects section • Indications & dosing schedules • Regulatory action (boxed warning, risk minimization action plan, withdrawl) 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 12
- 13. Conclusion Optimizing patient safety requires the reduction of potential harm before and after the marketing of a drug. Identifying the exact benefit- to-risk-ratio in a drug is necessary and those drugs in which risk outweigh benefits should be reserved only for specific diseases or populations. The post marketing of drugs needs to include doctors & patients to make informed decisions. Reporting of ADRs has become common practice and further studies must focus on implementing new ideas an dperhaps AI based models for easy detection of adverse events 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 13
- 14. Reference 1. https://www.fda.gov/drugs/surveillance/postmarketin g-adverse-event-reporting-compliance-program 2. https://pubmed.ncbi.nlm.nih.gov/21829783/ 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 14
- 15. Thank You! www.clinosol.com (India | Canada) 9121151622/623/624 info@clinosol.com 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 15