Narrative Writing
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Narrative writing is a form of writing that tells a story or describes a sequence of events. Narrative writing can take many forms, including novels, short stories, memoirs, personal essays, and even scientific or clinical case reports. The following are some key elements of narrative writing: Plot: The plot is the sequence of events that make up the story. It includes the exposition, rising action, climax, falling action, and resolution. The plot should be well-structured and engaging, with a clear beginning, middle, and end. Characters: The characters are the people, animals, or other beings that are involved in the story. Characters should be well-developed and believable, with their own personalities, motivations, and conflicts. Setting: The setting is the time and place in which the story takes place. The setting should be described in detail, with attention paid to the sights, sounds, smells, and other sensory details that create a sense of atmosphere. Point of view: The point of view is the perspective from which the story is told. It can be first-person (using "I" or "we"), second-person (using "you"), or third-person (using "he," "she," or "they"). The point of view should be consistent throughout the story. Theme: The theme is the central idea or message of the story. It can be implicit or explicit, and may explore universal themes such as love, loss, or redemption.
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6 Epidemiologic Study Designs feke.ppptx
may be reproduced or distributed in any form or by any means, or stored in a data base or
retrieval system, without the prior written permission of the publisher.
Previous editions copyright © 2015, 2012, 2010, 2009, 2007, 2004, 2001 by McGraw-Hill Companies, Inc.; copyright © 1998, 1995, 1992, 1989,
1987 by Appleton & Lange; copyright © 1984, 1982 by Lange Medical Publications.
1 2 3 4 5 6 7 8 9 LWI 22 21 20 19 18 17
ISBN 978-1-259-64115-2
MHID 1-259-64115-5
ISSN 0891-2033
Notice
Medicine is an ever-changing science. As new research and clinical experience broaden our knowledge, changes in treatment and drug therapy
are required. The authors and the publisher of this work have checked with sources believed to be reliable in their efforts to provide information that is complete and generally in accord with the standards accepted at the time of publication. However, in view of the possibility of
human error or changes in medical sciences, neither the authors nor the publisher nor any other party who has been involved in the preparation or publication of this work warrants that the information contained herein is in every respect accurate or complete, and they disclaim all
responsibility for any errors or omissions or for the results obtained from use of the information contained in this work. Readers are encouraged to confirm the information contained herein with other sources. For example and in particular, readers are advised to check the product
information sheet included in the package of each drug they plan to administer to be certain that the information contained in this work is
accurate and that changes have not been made in the recommended dose or in the contraindications for administration. This recommendation
is of particular importance in connection with new or infrequently used drugs.
This book was set in Adobe Garamond by Cenveo® Publisher Services.
The editors were Michael Weitz and Peter Boyle.
The copyeditors were Caroline Define and Greg Feldman.
The production supervisor was Richard Ruzycka.
Project management provided by Neha Bhargava, Cenveo Publisher Services.
Cover photo: Tumor necrosis factor alpha (TNF-a) cytokine protein molecule, 3D rendering. Clinically used inhibitors include infliximab,
adalimumab, certolizumab and etanercept.
Photo credit: Shutterstock.
This book is printed on acid-free paper.
McGraw-Hill Education books are available at special quantity discounts to use as premiums and sales promotions, or for use in corporate training
programs. To contact a representative please visit the Contact Us pages at www.mhprofessional.com.
International Edition ISBN 978-1-260-28817-9; MHID 1-260-28817-X.
Copyright © 2018. Exclusive rights by McGraw-Hill Education for manufacture and export. This book cannot be re-exported from the countryand also survilance data must be dent it how it is thbt monmt to over ride to bedone on them about of corundum taper roundtable action on it them it that about on holder them thi
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6 Epidemiologic Study Designs feke.ppptx
may be reproduced or distributed in any form or by any means, or stored in a data base or
retrieval system, without the prior written permission of the publisher.
Previous editions copyright © 2015, 2012, 2010, 2009, 2007, 2004, 2001 by McGraw-Hill Companies, Inc.; copyright © 1998, 1995, 1992, 1989,
1987 by Appleton & Lange; copyright © 1984, 1982 by Lange Medical Publications.
1 2 3 4 5 6 7 8 9 LWI 22 21 20 19 18 17
ISBN 978-1-259-64115-2
MHID 1-259-64115-5
ISSN 0891-2033
Notice
Medicine is an ever-changing science. As new research and clinical experience broaden our knowledge, changes in treatment and drug therapy
are required. The authors and the publisher of this work have checked with sources believed to be reliable in their efforts to provide information that is complete and generally in accord with the standards accepted at the time of publication. However, in view of the possibility of
human error or changes in medical sciences, neither the authors nor the publisher nor any other party who has been involved in the preparation or publication of this work warrants that the information contained herein is in every respect accurate or complete, and they disclaim all
responsibility for any errors or omissions or for the results obtained from use of the information contained in this work. Readers are encouraged to confirm the information contained herein with other sources. For example and in particular, readers are advised to check the product
information sheet included in the package of each drug they plan to administer to be certain that the information contained in this work is
accurate and that changes have not been made in the recommended dose or in the contraindications for administration. This recommendation
is of particular importance in connection with new or infrequently used drugs.
This book was set in Adobe Garamond by Cenveo® Publisher Services.
The editors were Michael Weitz and Peter Boyle.
The copyeditors were Caroline Define and Greg Feldman.
The production supervisor was Richard Ruzycka.
Project management provided by Neha Bhargava, Cenveo Publisher Services.
Cover photo: Tumor necrosis factor alpha (TNF-a) cytokine protein molecule, 3D rendering. Clinically used inhibitors include infliximab,
adalimumab, certolizumab and etanercept.
Photo credit: Shutterstock.
This book is printed on acid-free paper.
McGraw-Hill Education books are available at special quantity discounts to use as premiums and sales promotions, or for use in corporate training
programs. To contact a representative please visit the Contact Us pages at www.mhprofessional.com.
International Edition ISBN 978-1-260-28817-9; MHID 1-260-28817-X.
Copyright © 2018. Exclusive rights by McGraw-Hill Education for manufacture and export. This book cannot be re-exported from the countryand also survilance data must be dent it how it is thbt monmt to over ride to bedone on them about of corundum taper roundtable action on it them it that about on holder them thi
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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.
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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.
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Supplementing Randomized Controlled Trials (RCTs): RWE can complement findings from traditional RCTs by providing a broader understanding of how interventions perform in diverse patient populations, real-world healthcare settings, and long-term follow-up. RWE can provide insights into treatment outcomes, patient adherence, comparative effectiveness, and safety profiles.
Expanded Patient Populations: RCTs often have strict eligibility criteria, leading to a limited representation of the real-world patient population. RWE can include a more diverse range of patients, including those with comorbidities, different demographics, and varying treatment histories. This allows for a better understanding of how interventions work in broader patient populations.
Longitudinal Data and Real-World Outcomes: RWE can capture long-term outcomes and provide insights into the effectiveness and safety of interventions over extended periods. By observing patients in their natural healthcare settings, RWE can assess real-world clinical outcomes, healthcare resource utilization, and patient-reported outcomes.
Comparative Effectiveness Research: RWE enables comparative effectiveness research by comparing multiple interventions, treatment strategies, or healthcare delivery approaches in real-world settings. This helps inform clinical decision-making by evaluating the benefits and risks of different treatment options and understanding their impact on patient outcomes.
Safety Surveillance and Adverse Event Monitoring: RWE can play a vital role in post-marketing surveillance by identifying and monitoring adverse events or safety signals associated with medical interventions in real-world populations. This allows for early detection and investigation of potential safety concerns, leading to timely interventions and improved patient safety.
Health Economics and Outcomes Research (HEOR): RWE can be used to assess the economic impact of interventions, including cost-effectiveness, healthcare resource utilization, and budget impact. This information aids in healthcare decision-making by evaluating the value and sustainability of interventions within the healthcare system.
Data Quality and Methodological Considerations: Ensuring the quality and reliability of RWE is crucial. Rigorous data collection methods, standardized data elements, and appropriate statistical methodologies should be employed. Efforts should be made to address biases, confounding factors, and data limitations inherent in rea
My Top 5 articles from 2015-16 about Informatics and Digital Health in Physio...
The document discusses how digital health and informatics can influence physiotherapy management and outcomes for stroke patients. It reviews 5 articles on this topic. The articles found that electronic medical records (EMRs) can help implement evidence-based guidelines, standardize care, improve documentation and coordination, and enable monitoring of patient progress. EMRs also allow identifying patients for research studies and individualizing rehabilitation. The document recommends that EMRs for stroke patients include clinical pathways, order sets, structured physiotherapy forms, and an evidence-based early mobilization strategy. Overall, incorporating digital health can help translate knowledge into practice and improve stroke care when implementing an EMR.
Bias in clinical research
This is an interesting ppt discussing in detail about bias in clinical research and how to overcome it...
3 Research methods and materials (1).pptx
This document provides an overview of various research methods and study designs, including:
- Descriptive studies like ecological, case report, and cross-sectional studies which describe disease occurrence.
- Analytical observational studies like case-control studies which compare exposure histories of cases and controls to identify potential risk factors.
- The key components of research methods are discussed, such as study area, population, variables, sample size calculation, and data collection and analysis plans. Strengths and limitations of different study designs are also reviewed.
Manjinder kaur 2022.docx
This document discusses establishing surveillance programs in healthcare facilities to monitor infection risks. It recommends developing a written surveillance plan with clear goals and objectives. The plan should focus surveillance on high-risk patient groups, procedures, or pathogens. Data collection methods like active surveillance are most sensitive but also most resource-intensive. Targeted surveillance of specific infections or units allows resources to focus on the highest risks. Regular analysis and reporting of infection rates helps evaluate the surveillance program and direct prevention efforts.
Developments in Clinical Trials
This document provides an overview of developments in clinical trial design, with a focus on adaptive designs. It discusses how adaptive designs allow trials to be modified based on accumulating data to make trials more efficient. The number of adaptive design trials has been growing annually by an average of 11.5%. Various types of adaptive designs are described, including exploratory, confirmatory, seamless, and enrichment designs. Specific examples highlight how adaptive designs can help drop ineffective treatments earlier and identify more promising treatments. Regulatory progress on adaptive designs and remaining hurdles are also discussed.
Evidence based medicine
This topic is very essential for Pharm.D students. It includes application, benefits, limitations of EBM. It also includes EBM history and background which helps you for examinations. EBM is very important topic in Pharmacotherapeutics-III so you may find this needful.
All the best!!!
STARSurgUK Protocol v5.3
The final protocol (v5.3). Notable changes include:
1) Confirmation of audit standard (Page 6).
2) Refinement of inclusion and exclusion criteria (Page 7)
3) Confirmation of audit status (Appendix C)
4) Refinement of required data fields (Page 19) including definitions (Pages 20-25)
Nw biotech fundamentals day 2 session 4 medical devices and diagnostics
In this presentation:
• Definition of Medical devices and Diagnostics
• The stages of an R&D project
• The state of the art
• Regulatory nuances
• Future trends
• Challenges and opportunities
• Case studies and examples
Vaccine safety
Vaccines are an essential method for preventing infectious diseases. While vaccination programs have reduced disease rates, vaccine safety continues to be monitored. An extensive vaccine safety review found limited understanding of adverse events due to insufficient research. Improving research capacity is needed so future reviews are not handicapped. Both pre-licensure clinical trials and post-licensure surveillance systems aim to monitor vaccine safety, though assessing rare adverse events poses challenges requiring large studies and international collaboration. Standardized methods and ongoing evaluation aim to maintain public confidence in vaccination.
What is an adverse drug reaction and different types of ADRS
An adverse drug reaction (ADR) is any harmful or unintended response to a medication or drug, which occurs at doses normally used for prevention, diagnosis, or treatment of a disease or disorder. ADRs can range from mild symptoms such as a rash or nausea to severe reactions such as organ failure or death. Here are the different types of ADRs:
Type A ADRs: Type A ADRs are predictable and are related to the pharmacological action of the drug. These reactions are usually dose-dependent, and their incidence increases with the drug dose. Common examples include nausea, vomiting, constipation, dizziness, and sedation.
Type B ADRs: Type B ADRs are unpredictable and are not related to the pharmacological action of the drug. These reactions are usually idiosyncratic and occur in only a small percentage of patients. Examples include allergic reactions, drug-induced liver injury, and blood disorders.
Type C ADRs: Type C ADRs are chronic and occur after prolonged use of the drug. These reactions are usually dose-dependent and may lead to long-term damage or injury. Examples include bone loss, adrenal suppression, and Cushing's syndrome.
Type D ADRs: Type D ADRs are delayed reactions and occur after the patient has stopped taking the drug. These reactions are usually related to the long half-life of the drug or its metabolites. Examples include tardive dyskinesia, drug-induced cancer, and teratogenic effects.
Type E ADRs: Type E ADRs are end-of-treatment reactions and occur after the patient has completed a course of treatment with the drug. These reactions are usually related to the withdrawal of the drug and may include symptoms such as rebound hypertension, depression, or anxiety.
Type F ADRs: Type F ADRs are failure of therapy reactions and occur when the drug fails to produce the desired therapeutic effect. These reactions may be due to drug interactions, poor compliance, or underlying disease progression.
Webinar pv use case 23 march2016
Scientific and medical literature is an important source of information for pharmacovigilance and detecting adverse drug reactions. However, marketing authorization holders face challenges in systematically reviewing literature due to a lack of harmonization across regulatory authorities and in developing effective search strategies. Literature screening is important for evaluating drug safety and can impact decisions regarding a drug's risk-benefit analysis. It is important that literature screening is done systematically and documented properly.
Casey, "Measuring Science Impact Among Citations (case studies)"
Casey, "Measuring Science Impact Among Citations (case studies)"National Information Standards Organization (NISO)
The document describes how the CDC's Science Impact Framework can be used to measure the impact of scientific work beyond just citation data. It provides three case studies that will illustrate how the framework can be applied. The framework uses a combination of quantitative and qualitative indicators to measure outcomes across five levels of influence: disseminating science, creating awareness, catalyzing action, effecting change, and shaping the future. The case studies will demonstrate how scientific work can have a complex path of impact that does not necessarily follow a linear progression through these levels of influence.Similar to Narrative Writing (20)
Η συνεισφορά της Γενικής Οικογενειακής Ιατρικής στη Φαρμακοεπιδημιολογία
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Clinical oncology-can-observational-research-impact-clinical-decision-making
Clinical oncology-can-observational-research-impact-clinical-decision-making
Real-World Evidence: Harnessing Data for Clinical Decision-Making
Real-World Evidence: Harnessing Data for Clinical Decision-Making
My Top 5 articles from 2015-16 about Informatics and Digital Health in Physio...
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Nw biotech fundamentals day 2 session 4 medical devices and diagnostics
Nw biotech fundamentals day 2 session 4 medical devices and diagnostics
What is an adverse drug reaction and different types of ADRS
What is an adverse drug reaction and different types of ADRS
Casey, "Measuring Science Impact Among Citations (case studies)"
Casey, "Measuring Science Impact Among Citations (case studies)"
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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.
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.
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.
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Narrative Writing
- 1. Welcome Narrative Writing Dr. Akshaya D BDS, MPH(Epidemiology and Biostatistics) CSRPL_STD_IND_HYD_ONL/CL S_034/022023 5/5/2023 www.clinosol.com | follow us on social media @clinosolresearch
- 2. What is narrative writing? • It is a style that allows the writer to tell a story. • It may include actual events told in chronological order or, • Imagined events told in a timeline created by the author. • Narrative writing should sustain the reader’s attention and help them visualize a realistic experience from the words. • Narrative writing is an important part of Pharmacovigilance(post marketing study reports) and in clinical study reports(CSR). • Patient narratives are written when there is an adverse events and serious adverse events including death. 5/5/2023 www.clinosol.com | follow us on social media @clinosolresearch 2
- 3. ICH Guidelines on CSR • A narrative thus is basically a summary or synopsis of the event that has occurred to a subject participating in the clinical trial. • According to the International Conference on Harmonisation (ICH) tripartite guideline on the Structure and Content of Clinical Study Reports (CSRs) E3 (Section 12.3.2), a CSR should contain brief narratives describing each death, each other serious adverse event, and other significant adverse events that are judged to be of special interest because of clinical importance • A CIOMS report can be cited as an example of a narrative which provides valuable information about the occurrence of the event. 5/5/2023 www.clinosol.com | follow us on social media @clinosolresearch 3
- 4. Cont.… • As Per ICH E3 guidelines, a patient safety narrative should describe the following: • the nature, intensity, and outcome of the event • the clinical course leading to the event • an indication of timing relevant to study drug administration • relevant laboratory measures • action taken with the study drug (and timing) in relation to the event • treatment or intervention • post-mortem findings (if applicable) • Investigator’s and Sponsor’s (if appropriate) opinion on causality 5/5/2023 www.clinosol.com | follow us on social media @clinosolresearch 4
- 5. The narrative should mention, • patient identifier or subject ID • age and sex of patient; general clinical condition of patient, if appropriate • disease being treated (if this is the same for all patients, this information is not required) with duration (of current episode) of illness • relevant concomitant/previous illnesses with details of occurrence/duration • relevant concomitant/previous medication with details of dosage • test drug administered, including dose, if this varied among patients, and length of time administered 5/5/2023 www.clinosol.com | follow us on social media @clinosolresearch 5
- 6. Data Source 5/5/2023 www.clinosol.com | follow us on social media @clinosolresearch 6 • A Medical Writer will use various sources of information when preparing patient safety narratives. • These include Council for International Organizations of Medical Sciences (CIOMS) forms, Case Report Forms (CRFs), MedWatch forms, Data Clarification Forms (DCFs), and clinical database listings. • Because source data are captured during study conduct and narratives are often prepared prior to database reconciliation and lock, a Medical Writer is often able to identify data discrepancies between the clinical study database and other sources. • The situation is complicated further as CIOMS forms are updated on an ongoing basis during a clinical study. • A Medical Writer is well placed to assess the impact of any discrepancies and provide feedback to a Sponsor, thereby assisting with the data cleaning process.
- 7. FORMAT & LOCATION FOR NARRATIVES 5/5/2023 www.clinosol.com | follow us on social media @clinosolresearch 7 • The guidance is less specific with regard to the format and location of patient safety narratives, stating [they] can be placed either in the text of the CSR or in Section 14.3.3 (Narratives of Deaths, Other Serious and Certain Other Significant Adverse Events), depending on their number. • Although no cut-off is specified, this author suggests that five or fewer narratives may logically and clearly be reported in text, although this is dependent on several factors, including therapeutic area, complexity of reporting, relevant course of events, and flow of information in the CSR. • If in doubt, it is recommended that narratives should be prepared as separate documents and compiled in Section 14.3.3 during CSR publishing.
- 8. PROCESS • The narrative production process differs across companies and is dependent to a small degree on whether reporting is performed internally or by a Clinical Research Organization (CRO). • INDIVIDUAL CASE SAFETY REPORTS • patient safety narratives and Individual Case Safety Reports (ICSRs) are not the same. ICSRs are a core component of pharmacovigilance (PV) services and drug safety. • A patient safety narrative in, or appended to, a CSR describes all relevant events for a single patient, with relevant background information • . An ICSR concerns one patient, one or more identifiable reporter(s), one or more suspected adverse reaction(s) that are clinically and temporally associated, and one or more suspected medicinal product(s). 5/5/2023 www.clinosol.com | follow us on social media @clinosolresearch 8
- 9. REFERENCES 1. International Conference on Harmonisation. July 1996. Topic E3 Structure and Content of Clinical Study Reports. 2. EMEA (now EMA; European Medicines Agency). December 2004. Note for Guidance on the Inclusion of Appendices to Clinical Study Reports in Marketing Authorisation Applications. 3. Volume 9A of The Rules Governing Medicinal Products in the European Union – Guidelines on Pharmacovigilance for Medicinal Products for Human Use. 2011. Part II [ONLINE] Available at: http://ec.europa.eu/health/files/eudralex/vol-9/pdf/vol9a_09 2008_en.pdf. [Accessed 29 January 2014]. 4. Volume 9A of The Rules Governing Medicinal Products in the European Union – Guidelines on Pharmacovigilance for Medicinal Products for Human Use. 2011. Annex 1.2. [ONLINE] Available at: http://ec.europa.eu/health/files/eudralex/vol-9/pdf/vol9a_09- 2008_en.pdf. 5/5/2023 www.clinosol.com | follow us on social media @clinosolresearch 9
- 10. Thank You! www.clinosol.com (India | Canada) 9121151622/623/624 info@clinosol.com 5/5/2023 www.clinosol.com | follow us on social media @clinosolresearch 10