The document provides an overview of health technology assessment (HTA) in the United States. It describes the history of HTA in the US beginning in the 1960s. It notes that the structure of HTA in the US is decentralized, fragmented, and duplicative compared to other countries with national HTA frameworks. Both public sector organizations like AHRQ, CMS, VA, and state programs, as well as private sector organizations conduct HTA, but they vary in their purpose, scope, methods and characteristics. The document outlines some of the key public and private sector HTA programs and organizations in the US.
The document discusses the role of the Data and Safety Monitoring Board (DSMB) in overseeing clinical trials. The DSMB is an independent group that reviews accumulating trial data to protect participant safety and scientific validity. Key responsibilities include monitoring safety, efficacy, data quality and trial conduct. The DSMB can recommend stopping, continuing or modifying a trial based on interim analysis of unblinded data. Independence and confidentiality of the DSMB process is important to reduce bias and conflicts of interest.
Presentation delivered by Lori A. Tierney, BSN, Director, Site Management Operations, Allergan, Inc. at the marcus evans Evolution Summit Fall 2019 in San Diego CA.
The International Conference on Harmonisation (ICH) is a joint initiative involving regulators from Europe, Japan, and the United States along with research-based pharmaceutical companies to discuss scientific and technical requirements for drug approval. The goal of ICH is to harmonize these requirements to ensure safe and effective drugs are approved efficiently. ICH has created guidelines on topics like good clinical practice, quality assurance, efficacy, and safety that are followed by regulatory agencies worldwide.
Ministry of health labour and welfare (mhlw)MUGDHAANAVATTI
The document provides information about the Ministry of Health, Labour and Welfare (MHLW) in Japan. It discusses the following key points:
1. MHLW was established in 2001 by merging the Ministry of Health and Welfare and Ministry of Labor. It regulates pharmaceuticals, medical devices, health insurance, and more.
2. MHLW is made up of various bureaus, councils, affiliated institutions, and local branches. It oversees areas like health policy, medical care, food safety, employment security, and pensions.
3. The Pharmaceutical and Medical Devices Agency was established in 2004 to conduct drug and device approval reviews and post-marketing surveillance to ensure public health.
Sandra Maddock, RN, BSN, CCRA and President of IMARC Research, Inc. presents on Applying FDA’s Risk-Based Approach in an audio conference on September 11, 2012.
PHARMACOVIGILANCE - A Worldwide masterkey for Drug MonitoringVenugopal N
This document provides a history of pharmacovigilance and discusses key aspects of the field. It begins with important milestones in drug safety regulation dating back to the early 20th century. It then defines pharmacovigilance and describes stakeholders, methods used like individual case safety reporting, and the roles of organizations like the WHO and national regulatory authorities. The document emphasizes the importance of post-market drug safety monitoring to protect public health.
Introduction to Pharmacovigilance Signal DetectionPerficient
This document provides an introduction to signal detection in pharmacovigilance. It defines key terms like signal and signal detection. It describes qualitative and quantitative signal detection methods including individual case review, data mining algorithms to calculate disproportionality ratios from large safety databases, and visualization tools. Challenges with signal detection include determining what constitutes a "large enough" safety database and assumptions made when using spontaneous reporting data. The document outlines the signal management process from detection to prioritization and evaluation.
Elizabeth Mansfield, PhD, discusses the FDA’s approach to regulation
of in vitro diagnostic tests.
Part of Dx2010, a workshop at MaRS focused on best practices and regulatory considerations for developing gene-based diagnostic and prognostic tests.
The document discusses the role of the Data and Safety Monitoring Board (DSMB) in overseeing clinical trials. The DSMB is an independent group that reviews accumulating trial data to protect participant safety and scientific validity. Key responsibilities include monitoring safety, efficacy, data quality and trial conduct. The DSMB can recommend stopping, continuing or modifying a trial based on interim analysis of unblinded data. Independence and confidentiality of the DSMB process is important to reduce bias and conflicts of interest.
Presentation delivered by Lori A. Tierney, BSN, Director, Site Management Operations, Allergan, Inc. at the marcus evans Evolution Summit Fall 2019 in San Diego CA.
The International Conference on Harmonisation (ICH) is a joint initiative involving regulators from Europe, Japan, and the United States along with research-based pharmaceutical companies to discuss scientific and technical requirements for drug approval. The goal of ICH is to harmonize these requirements to ensure safe and effective drugs are approved efficiently. ICH has created guidelines on topics like good clinical practice, quality assurance, efficacy, and safety that are followed by regulatory agencies worldwide.
Ministry of health labour and welfare (mhlw)MUGDHAANAVATTI
The document provides information about the Ministry of Health, Labour and Welfare (MHLW) in Japan. It discusses the following key points:
1. MHLW was established in 2001 by merging the Ministry of Health and Welfare and Ministry of Labor. It regulates pharmaceuticals, medical devices, health insurance, and more.
2. MHLW is made up of various bureaus, councils, affiliated institutions, and local branches. It oversees areas like health policy, medical care, food safety, employment security, and pensions.
3. The Pharmaceutical and Medical Devices Agency was established in 2004 to conduct drug and device approval reviews and post-marketing surveillance to ensure public health.
Sandra Maddock, RN, BSN, CCRA and President of IMARC Research, Inc. presents on Applying FDA’s Risk-Based Approach in an audio conference on September 11, 2012.
PHARMACOVIGILANCE - A Worldwide masterkey for Drug MonitoringVenugopal N
This document provides a history of pharmacovigilance and discusses key aspects of the field. It begins with important milestones in drug safety regulation dating back to the early 20th century. It then defines pharmacovigilance and describes stakeholders, methods used like individual case safety reporting, and the roles of organizations like the WHO and national regulatory authorities. The document emphasizes the importance of post-market drug safety monitoring to protect public health.
Introduction to Pharmacovigilance Signal DetectionPerficient
This document provides an introduction to signal detection in pharmacovigilance. It defines key terms like signal and signal detection. It describes qualitative and quantitative signal detection methods including individual case review, data mining algorithms to calculate disproportionality ratios from large safety databases, and visualization tools. Challenges with signal detection include determining what constitutes a "large enough" safety database and assumptions made when using spontaneous reporting data. The document outlines the signal management process from detection to prioritization and evaluation.
Elizabeth Mansfield, PhD, discusses the FDA’s approach to regulation
of in vitro diagnostic tests.
Part of Dx2010, a workshop at MaRS focused on best practices and regulatory considerations for developing gene-based diagnostic and prognostic tests.
The document discusses various ICH guidelines related to quality, safety and efficacy of pharmaceuticals. It provides an overview of ICH (International Conference on Harmonization), its objectives to harmonize technical requirements for drug development and registration. Key guidelines discussed include Q1A-Q1F on stability testing, Q2 on analytical validation, Q3A-Q3D on impurities and Q4-Q5E on quality of biopharmaceutical products. The document describes the structure of ICH including its steering committee, coordinators, secretariat and working groups.
This ppt provides a brief overview of the regulatory evaluationprocess for New Applications under various types - Mutual recognition process, Decentralized procedure along with an overview of Grouping variations & Worksharing procedures.
> Why HEOR?
> Costs, Consequences and Perspectives
> Key Stakeholders in HEOR
> What is Health Economics and Pharmaco-economic Research?
> Economic Evaluations
> Incremental Cost Effectiveness Ratio (ICER)
> Concept of HRQoL
> Comparative Effectiveness Research (CER)
> Pragmatic Clinical Trials
> Observational Studies
> Systematic Reviews and Meta-Analysis
> Application of CER
> Health Technology Assessment (HTA)
> Real World Evidence (RWE)
> Patient Reported Outcomes (PROs)
> Patient Focused Drug Development (PFDD)
> Application of Health Economic Evaluations
> Challenges and Barriers
The document discusses clinical trial regulation in the European Union. It provides information on two key directives - Directive 2001/20/EC which describes requirements for conducting clinical trials in the EU, and Commission Directive 2005/28/EC which implements principles of good clinical practice. It then summarizes Regulation 536/2014 adopted in 2014 which established a new regulation for clinical trials of medicinal products in the EU with the aim of increasing patient safety, reliability of data, and efficiency of trials. The regulation includes provisions for single submission of documentation, centralized assessment, transparency, informed consent, and safety reporting among others.
This document discusses pharmacovigilance risk management audits. It defines an audit and explains why pharmacovigilance system audits are performed. It describes different types of audits, including global pharmacovigilance system audits, company affiliate audits, and marketing partner audits. It also outlines audit scheduling, fundamentals, reporting, corrective actions, follow-up, metrics, and inspection readiness best practices. The overall purpose of pharmacovigilance audits is to ensure compliance and patient safety.
USFDA Approval Process For Drug Products & Biological Product i.e NDA Vs. BLA
Comparison of NDA and BLA application process in USA. IND, NDA, ANDA & BLA dossier submission procedure.
To compare filing process of NDA of different countries of India, US and Euro...Aakashdeep Raval
To compare filing process of NDA of different countries of India, US and Europe.
B) Preparation of global list documents of registration of IND and NDA as per USFDA and Europe.
Overview of FDA Regulation of Medical DevicesMichael Swit
The document is a slide presentation by Michael A. Swit, Esq. on an overview of FDA regulation, with an emphasis on medical devices. It begins with definitions of key terms under FDA regulation such as drugs, biologics, devices, foods, dietary supplements, and cosmetics. It then discusses the mission and structure of the FDA, including the different centers that regulate specific product areas. The presentation provides an overview of the classification system for medical devices and regulatory pathways for devices, including 510(k) clearance and premarket approval.
Quantitative methods of Signal detection on spontaneous reporting systems - S...Francois MAIGNEN
The document discusses signal detection methods used by the European Medicines Agency (EMA) to analyze adverse event reports from EudraVigilance. It summarizes key signal detection concepts and methods, including disproportionality analysis using measures like the Proportional Reporting Ratio (PRR) to identify potential Signals of Disproportionate Reporting (SDRs). However, SDRs on their own do not imply causality and require medical evaluation to determine if they constitute true safety Signals worthy of further investigation or identified Risks associated with a medicine. The document also notes limitations of these quantitative methods and the subjective nature of defining thresholds and signals.
This document outlines procedures for reporting and managing serious adverse events (SAEs) related to research. It defines an SAE as an untoward medical occurrence that may not be causally related to the research. Investigators are responsible for reporting SAEs using a study-specific form within a specified timeframe. The chief investigator then reviews the SAE for seriousness, causality, and expectedness. For related or unexpected SAEs, the trial manager submits reports to the approving research ethics committee. The trial management group may provide consensus on SAE classifications as needed. The document provides detailed guidance on procedures for classifying, documenting, reporting and following up on SAEs.
This document discusses non-inferiority clinical trials and raises several issues with relying on such trials to approve new drugs. It notes that non-inferiority trials do not require new drugs to prove added benefits over existing standard therapies. This leaves the appropriate use and benefits of such new drugs unclear. The document questions whether patients would adequately consent to participate in trials where new treatments may be no better or even riskier than existing options. It argues superiority trials are preferable for demonstrating meaningful efficacy advantages of new drugs.
Pharmacoeconomics is the description and analysis of the costs of drug therapy to health systems and society. It identifies, measures, and compares the costs and outcomes of drug therapies and healthcare programs. Key methods include cost-of-illness, cost-benefit analysis, cost-effectiveness analysis, and cost-utility analysis. These evaluate the economic, clinical, and humanistic impacts of healthcare interventions from various perspectives including patients, providers, payers, and society.
Declaration: The materials incorporated in this document have come from variety of sources and compiler bears no responsibilities for any information contained herein. The compiler acknowledges all the sources although references have not been explicitly cited for all the contents in this document.
The document discusses various methods used for causality assessment of adverse drug reactions (ADRs), including algorithms. It outlines several algorithms such as the Karch & Lasagna, Begaud, Jones, Kramer, Naranjo, WHO-UMC, Thai, CIOMS/RUCAM, and ALDEN algorithms. Each algorithm has advantages and limitations. While the Naranjo algorithm is simple and brief, its dependability and validity are not confirmed for all populations. The WHO-UMC criteria are intended as a convenient tool for individual case reports but have limitations. Specific algorithms like CIOMS/RUCAM and ALDEN are used for certain ADRs. The best algorithm depends on the type of
Raj Bhogal, Head of Regulatory Inspections, R&D Quality Takeda on the topic of 'Pharmacovigilance Inspections' at IFAH held at Le Meridien, Dubai on 16th - 18th December, 2019.
The document provides an overview of the regulatory environment for therapeutic goods in the USA, Europe, and India. It summarizes the key regulatory bodies and clinical research guidelines in each region. In the USA, the FDA regulates clinical research and ensures drug safety. In Europe, the EMEA provides scientific evaluation of medicines, while the MHRA is the regulatory authority in the UK. In India, the DCGI and CDSCO regulate clinical trials under the Drugs Controller General of India. Clinical trials must adhere to Schedule Y of the Drugs and Cosmetics Act as well as other guidelines.
The Food and Drug Administration (FDA) released Clinical Trial Imaging Endpoint Process Standards guidance for clinical trials industry. Why? To standardize. To automate. To move closer to zero-delay clinical trials. Read AG Mednet's perspective on this FDA guidance.
The document discusses New Drug Applications (NDAs) submitted to the FDA for approval of new drug products. It describes how NDAs contain data from animal and human clinical trials demonstrating a drug's safety and effectiveness. There are different types of NDAs depending on if a drug is novel or similar to existing drugs. The FDA reviews NDAs to determine if manufacturing is adequate and if a drug's benefits outweigh its risks based on the application contents and recommendations are made for approval or further work required. Approved drugs require ongoing safety monitoring and reporting to the FDA.
This document provides an overview of pharmacovigilance basics. It defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. The document discusses key events in pharmacovigilance such as the thalidomide disaster and various drug withdrawals. It also covers adverse event reporting requirements and challenges, the importance of pharmacovigilance in ensuring drug safety, and common pharmacovigilance terms and concepts.
9054 Cardiff Student Poster final .6.08bNicola Allen
This study aimed to systematically characterize and compare the processes for new medicine approval and reimbursement across different countries. The researchers created process maps for 11 countries that identified the key agencies involved, milestones, and activities. They found considerable variability between countries in terms of which agencies conducted evaluations, how they were connected, and where health technology assessment was included in the process. By developing this standardized framework for comparison, future studies can more easily analyze differences in factors like reimbursement timelines between nations.
An Emergent Research And Policy Framework For TelehealthYasmine Anino
This document proposes a framework to guide research and policy on telehealth. An expert group developed the framework to integrate regulatory, operational, and clinical factors influencing telehealth. The framework encompasses the policy context for telehealth, delivery system factors, and outcomes of telehealth interventions. Feedback suggested the framework could help educate on telehealth value and barriers like costs and culture. However, questions remain on disseminating and using the framework to coordinate policy, research, and implementation efforts.
The document discusses various ICH guidelines related to quality, safety and efficacy of pharmaceuticals. It provides an overview of ICH (International Conference on Harmonization), its objectives to harmonize technical requirements for drug development and registration. Key guidelines discussed include Q1A-Q1F on stability testing, Q2 on analytical validation, Q3A-Q3D on impurities and Q4-Q5E on quality of biopharmaceutical products. The document describes the structure of ICH including its steering committee, coordinators, secretariat and working groups.
This ppt provides a brief overview of the regulatory evaluationprocess for New Applications under various types - Mutual recognition process, Decentralized procedure along with an overview of Grouping variations & Worksharing procedures.
> Why HEOR?
> Costs, Consequences and Perspectives
> Key Stakeholders in HEOR
> What is Health Economics and Pharmaco-economic Research?
> Economic Evaluations
> Incremental Cost Effectiveness Ratio (ICER)
> Concept of HRQoL
> Comparative Effectiveness Research (CER)
> Pragmatic Clinical Trials
> Observational Studies
> Systematic Reviews and Meta-Analysis
> Application of CER
> Health Technology Assessment (HTA)
> Real World Evidence (RWE)
> Patient Reported Outcomes (PROs)
> Patient Focused Drug Development (PFDD)
> Application of Health Economic Evaluations
> Challenges and Barriers
The document discusses clinical trial regulation in the European Union. It provides information on two key directives - Directive 2001/20/EC which describes requirements for conducting clinical trials in the EU, and Commission Directive 2005/28/EC which implements principles of good clinical practice. It then summarizes Regulation 536/2014 adopted in 2014 which established a new regulation for clinical trials of medicinal products in the EU with the aim of increasing patient safety, reliability of data, and efficiency of trials. The regulation includes provisions for single submission of documentation, centralized assessment, transparency, informed consent, and safety reporting among others.
This document discusses pharmacovigilance risk management audits. It defines an audit and explains why pharmacovigilance system audits are performed. It describes different types of audits, including global pharmacovigilance system audits, company affiliate audits, and marketing partner audits. It also outlines audit scheduling, fundamentals, reporting, corrective actions, follow-up, metrics, and inspection readiness best practices. The overall purpose of pharmacovigilance audits is to ensure compliance and patient safety.
USFDA Approval Process For Drug Products & Biological Product i.e NDA Vs. BLA
Comparison of NDA and BLA application process in USA. IND, NDA, ANDA & BLA dossier submission procedure.
To compare filing process of NDA of different countries of India, US and Euro...Aakashdeep Raval
To compare filing process of NDA of different countries of India, US and Europe.
B) Preparation of global list documents of registration of IND and NDA as per USFDA and Europe.
Overview of FDA Regulation of Medical DevicesMichael Swit
The document is a slide presentation by Michael A. Swit, Esq. on an overview of FDA regulation, with an emphasis on medical devices. It begins with definitions of key terms under FDA regulation such as drugs, biologics, devices, foods, dietary supplements, and cosmetics. It then discusses the mission and structure of the FDA, including the different centers that regulate specific product areas. The presentation provides an overview of the classification system for medical devices and regulatory pathways for devices, including 510(k) clearance and premarket approval.
Quantitative methods of Signal detection on spontaneous reporting systems - S...Francois MAIGNEN
The document discusses signal detection methods used by the European Medicines Agency (EMA) to analyze adverse event reports from EudraVigilance. It summarizes key signal detection concepts and methods, including disproportionality analysis using measures like the Proportional Reporting Ratio (PRR) to identify potential Signals of Disproportionate Reporting (SDRs). However, SDRs on their own do not imply causality and require medical evaluation to determine if they constitute true safety Signals worthy of further investigation or identified Risks associated with a medicine. The document also notes limitations of these quantitative methods and the subjective nature of defining thresholds and signals.
This document outlines procedures for reporting and managing serious adverse events (SAEs) related to research. It defines an SAE as an untoward medical occurrence that may not be causally related to the research. Investigators are responsible for reporting SAEs using a study-specific form within a specified timeframe. The chief investigator then reviews the SAE for seriousness, causality, and expectedness. For related or unexpected SAEs, the trial manager submits reports to the approving research ethics committee. The trial management group may provide consensus on SAE classifications as needed. The document provides detailed guidance on procedures for classifying, documenting, reporting and following up on SAEs.
This document discusses non-inferiority clinical trials and raises several issues with relying on such trials to approve new drugs. It notes that non-inferiority trials do not require new drugs to prove added benefits over existing standard therapies. This leaves the appropriate use and benefits of such new drugs unclear. The document questions whether patients would adequately consent to participate in trials where new treatments may be no better or even riskier than existing options. It argues superiority trials are preferable for demonstrating meaningful efficacy advantages of new drugs.
Pharmacoeconomics is the description and analysis of the costs of drug therapy to health systems and society. It identifies, measures, and compares the costs and outcomes of drug therapies and healthcare programs. Key methods include cost-of-illness, cost-benefit analysis, cost-effectiveness analysis, and cost-utility analysis. These evaluate the economic, clinical, and humanistic impacts of healthcare interventions from various perspectives including patients, providers, payers, and society.
Declaration: The materials incorporated in this document have come from variety of sources and compiler bears no responsibilities for any information contained herein. The compiler acknowledges all the sources although references have not been explicitly cited for all the contents in this document.
The document discusses various methods used for causality assessment of adverse drug reactions (ADRs), including algorithms. It outlines several algorithms such as the Karch & Lasagna, Begaud, Jones, Kramer, Naranjo, WHO-UMC, Thai, CIOMS/RUCAM, and ALDEN algorithms. Each algorithm has advantages and limitations. While the Naranjo algorithm is simple and brief, its dependability and validity are not confirmed for all populations. The WHO-UMC criteria are intended as a convenient tool for individual case reports but have limitations. Specific algorithms like CIOMS/RUCAM and ALDEN are used for certain ADRs. The best algorithm depends on the type of
Raj Bhogal, Head of Regulatory Inspections, R&D Quality Takeda on the topic of 'Pharmacovigilance Inspections' at IFAH held at Le Meridien, Dubai on 16th - 18th December, 2019.
The document provides an overview of the regulatory environment for therapeutic goods in the USA, Europe, and India. It summarizes the key regulatory bodies and clinical research guidelines in each region. In the USA, the FDA regulates clinical research and ensures drug safety. In Europe, the EMEA provides scientific evaluation of medicines, while the MHRA is the regulatory authority in the UK. In India, the DCGI and CDSCO regulate clinical trials under the Drugs Controller General of India. Clinical trials must adhere to Schedule Y of the Drugs and Cosmetics Act as well as other guidelines.
The Food and Drug Administration (FDA) released Clinical Trial Imaging Endpoint Process Standards guidance for clinical trials industry. Why? To standardize. To automate. To move closer to zero-delay clinical trials. Read AG Mednet's perspective on this FDA guidance.
The document discusses New Drug Applications (NDAs) submitted to the FDA for approval of new drug products. It describes how NDAs contain data from animal and human clinical trials demonstrating a drug's safety and effectiveness. There are different types of NDAs depending on if a drug is novel or similar to existing drugs. The FDA reviews NDAs to determine if manufacturing is adequate and if a drug's benefits outweigh its risks based on the application contents and recommendations are made for approval or further work required. Approved drugs require ongoing safety monitoring and reporting to the FDA.
This document provides an overview of pharmacovigilance basics. It defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. The document discusses key events in pharmacovigilance such as the thalidomide disaster and various drug withdrawals. It also covers adverse event reporting requirements and challenges, the importance of pharmacovigilance in ensuring drug safety, and common pharmacovigilance terms and concepts.
9054 Cardiff Student Poster final .6.08bNicola Allen
This study aimed to systematically characterize and compare the processes for new medicine approval and reimbursement across different countries. The researchers created process maps for 11 countries that identified the key agencies involved, milestones, and activities. They found considerable variability between countries in terms of which agencies conducted evaluations, how they were connected, and where health technology assessment was included in the process. By developing this standardized framework for comparison, future studies can more easily analyze differences in factors like reimbursement timelines between nations.
An Emergent Research And Policy Framework For TelehealthYasmine Anino
This document proposes a framework to guide research and policy on telehealth. An expert group developed the framework to integrate regulatory, operational, and clinical factors influencing telehealth. The framework encompasses the policy context for telehealth, delivery system factors, and outcomes of telehealth interventions. Feedback suggested the framework could help educate on telehealth value and barriers like costs and culture. However, questions remain on disseminating and using the framework to coordinate policy, research, and implementation efforts.
The convergence of separate health systems has led to
a great increase in data, which some organisations are
struggling to get to grips with. Harnessing analytic tools
and sharing knowledge is the best way forward
This document provides an overview of drugs, medical devices, clinical trials, healthcare IT, and regulations. It discusses the types and administration of drugs. It describes medical devices and their types. It explains the objectives, design, and types of clinical trials. It discusses the role of IT in clinical trials and healthcare, including clinical trial management systems and electronic health records. It provides information on the healthcare and clinical trial management systems market. Finally, it lists some key regulating bodies and regulations.
Digital Scholar Webinar: Clinicaltrials.gov Registration and Reporting DocumentsSC CTSI at USC and CHLA
The document provides information about clinicaltrials.gov registration and reporting requirements. It discusses that the U.S. Department of Health and Human Services, National Institutes of Health (NIH) requires registration of applicable clinical trials on ClinicalTrials.gov. Registration must occur within 21 days of enrolling the first participant, and results must be reported within 12 months of trial completion. The document reviews the registration process, what types of trials must be registered, responsibilities of the responsible party, and penalties for noncompliance.
Slides from Society for Clinical Trials, The goal of this CTTI-sponsored project was to describe current clinical monitoring methods for a range of clinical trial types, and to explore the rationale for the use of those methods.
Healthcare data comes from various sources like electronic health records, personal health records, and health apps. Data analytics in healthcare represents automating the collection, processing, and analysis of complex healthcare data to provide insights and help practitioners make informed decisions. There are different types of analytics used in healthcare to address challenges like ever-changing medicine, mixed data sources, and emerging regulations. Examples include using analytics to speed up insurance claims submission by preparing them faster with fewer errors and predicting suicide attempts by classifying patients into risk groups.
The global health and life sciences market is large, complex and fragmented. While data flows freely, an information gap has formed. Pfizer has made investments in companies like Private Access, Keas and Acacia Living that focus on personalized healthcare, health and wellness, and empowering consumers. Pfizer also looks to form partnerships to solve complex problems through multi-stakeholder collaboration.
This document discusses using real world data from healthcare databases to support adaptive biomedical innovation. It outlines four key principles - meaningful, valid, expedited, and transparent evidence (MVET) - that are necessary to generate evidence from healthcare databases that is fit for decision making. Meaningful evidence requires using relevant and high quality data sources to answer the research question. Evidence should be generated and shared in a transparent manner while protecting patient privacy. Following MVET principles can help produce rigorous evidence from real world data to support faster access to new medications through adaptive pathways, while maintaining evidentiary standards.
Challenges and Opportunities Around Integration of Clinical Trials DataCitiusTech
Conducting a Clinical Trial is a complex process, consisting of activities such as protocol preparation, site selection, approval of various authorities, meticulous collection and management of data, analysis and reporting of the data collected
Each activity is benefited from the development of point applications which ease the process of data collection, reporting and decision making. The recent advancements in mobile technologies and connectivity has enabled the generation and exchange of a lot more data than previously anticipated. However, the lack of interoperability and proper planning to leverage this data, still acts as a roadblock in allowing organizations truly harness their data assets. This document will help life sciences IT professionals and decision makers understand challenges and opportunities around clinical data integration
This document provides an overview of electronic health record systems (EHRs). It discusses how EHRs are used by various healthcare professionals and departments to longitudinally collect and share patient health information. Key features of EHRs discussed include providing access to patient data, clinical decision support, supporting efficient healthcare processes, and enabling remote access to patient records. Several examples of early EHR systems developed by the VA, DoD, and IHS in the 1970s are provided. The role of government agencies and standards organizations in facilitating EHR adoption is also summarized.
RHIS3rd year regular generic HI (1).pptxEyobAlemu11
This document provides information about a Routine Health Information Systems course. It includes details about the course name, code, credit hours, target students, and instructor. The course contents cover 8 chapters on topics like health indicators, data sources, disease surveillance, and the District Health Information System (DHIS-2). The document also defines key terms, outlines the components and historical development of health information systems, and discusses the health management information system in Ethiopia.
The document discusses key aspects of regulating health care in the United States as covered in Lecture d. It describes the Health Insurance Portability and Accountability Act (HIPAA) which establishes requirements for protecting patient health information and applies to covered entities like health care providers, health plans, and clearinghouses. It also discusses efforts by organizations like The Joint Commission and Agency for Health Care Research and Quality to improve patient safety and reduce medical errors through initiatives and research.
Registries for Medical Devices in Europe Reflection Paper_January 2016Sebastian Gaiser
The document outlines 6 key principles for establishing medical device registries in Europe: 1) Define the scope, 2) Set up proper governance, 3) Establish fair and transparent financing, 4) Ensure collection of quality data and data protection, 5) Make data available and reported, and 6) Guarantee proper education and qualification. It argues that following these principles can improve the quality, acceptability and efficiency of collecting and analyzing registry data to further research and decision making.
Placing the Evolution of HTA In Emerging Markets in Context of Health System ...Office of Health Economics
These slides were presented by Professor Adrian Towse at the 9th World Congress of the International Health Economics Association in July 2013. The presentation examined how the development of health care systems affect the evolution of the use of health technology assessment. Three countries provide case studies: Brazil, China and Taiwan.
The document discusses challenges facing the healthcare industry and opportunities for collecting patient-reported outcomes data to inform coverage decisions. It notes the industry faces a "perfect storm" of healthcare reform uncertainties like expanding coverage and cost containment. Patient-reported outcomes data from registries, reimbursement programs, and adherence programs could provide evidence of effectiveness and be valuable to payers, but how and whether it will be used by decision-makers remains unclear. The document calls for developing more effective patient-reported outcomes instruments and engaging payers on how this data can be integrated into their coverage policies.
Survey Shows the Role of Technology in the Progress of Patient SafetyHealth Catalyst
A lack of effective technology is impeding the progress of patient safety, according to a 2018 survey of healthcare professionals. Even though most healthcare organizations claim safety as a priority, serious challenges remain to making a significant impact on patient safety outcomes.
Survey respondents said ineffective information technology and the related lack of real-time warnings for possible harm events were the top barriers to improving patient safety. They cited a number of key obstacles:
Lack of resources.
Organization structure.
Lack of reimbursement for safety measures.
Changes in patient population.
This survey of more than 400 healthcare professionals tackles a big question many hospital leaders are asking: Why aren’t we seeing improvements in patient safety despite our efforts?
21st Century Act and its Impact on Healthcare ITCitiusTech
This document gives an overview, core objectives of the act and enumerates purpose of each part / division of the 21st Century Act. It lists down the sections of the act which have a direct impact on Healthcare IT and gives a brief overview of each section.This document also explains the impact of 21st Century Cures Act on regulatory bodies: FDA / NIH / HSS.
1. The document discusses the evolution of health technology assessment (HTA) from its origins in responding to decision-maker needs to its current role in knowledge mobilization and supporting universal health coverage.
2. Key aspects of mature HTA systems include assessing a wide range of health technologies, strong stakeholder involvement, and knowledge translation activities.
3. For HTA to be effective, it requires both scientific expertise to conduct assessments and links to decision-making through governance and stakeholder participation.
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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...Donc Test
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There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
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Abdominal trauma in pediatrics refers to injuries or damage to the abdominal organs in children. It can occur due to various causes such as falls, motor vehicle accidents, sports-related injuries, and physical abuse. Children are more vulnerable to abdominal trauma due to their unique anatomical and physiological characteristics. Signs and symptoms include abdominal pain, tenderness, distension, vomiting, and signs of shock. Diagnosis involves physical examination, imaging studies, and laboratory tests. Management depends on the severity and may involve conservative treatment or surgical intervention. Prevention is crucial in reducing the incidence of abdominal trauma in children.
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
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3. 3
History
1967 : The term was used in the US Congress
1972: Office of Technology Assessment (OTA) was
established
1978: National Center for Health Care Technology
CT scanner was the first target for HTA
Source: Perry 1988
4. 4
Structure
The US has not a national HTA framework
Public and private mix structure
HTA is quite fragmented and uncoordinated
Includes both public and private sector initiatives
In contrast to other Developed countries, the current state of
technology assessment the US is
Decentralized
Fragmented
Duplicative
Source: Perry 1988, ISPOR
5. 5
Structure
In contrast to federal HTA activity, the growth of HTA
organizations within the private sector has been consistent
and significant.
The growth of HTA in the United States has been largely
restricted to the private sector
In the U.S., both government-funded and private entities
generate HTAs.
Source : Haas 2007, Ware 2009
6. 6
Structure
The purposes, scope, methods, and other characteristics of
HTAs that are conducted or sponsored by these organizations
vary widely
However, the structure, procedures, and goals of each of
these organizations differ greatly from one another.
Source: Haas 2007
7. 7
Public sector has HTA activities:
Minnesota Health Services Advisory Council (HSAC)
Oregon Health Resources Commission (HRC)
Washington Health Technology Assessment Program (WA-
HTA)
VA (Veterans Administration)
FDA(Food and Drug Administration)
AHRQ(Agency for Health Research and Quality )
Source: Sullivan 2009
8. 8
Private sector has HTA activities:
Insurance Companies
Hospitals
Medical/device Manufacturers
Consulting Firms
Health Professional Organizations
Academic Medical Centers
Source :Perry 1997
9. 9
HTA organizations existed in the US
Source :Perry 1997
Type of organization Number Time per assessment
Federal 7 1-24
State 3 6-9
Hospitals 5 2-10(w)
Health insurance 11 1-10(d)
Health professions 8 6-36
Academic/Not for profit
research
12
2-120(d)
Consulting firms 4 3-6(w)
Drug/device
manufactures
3
1-120(d)
10. 10
Distribution of US HTA programs in 1995 by type of organizations
Source: Perry 1997
11. 11
The Office of Technology Assessment
The OTA was established in 1972
Technology assessments to inform federal funding decisions
about emerging health and no health technology
The OTA model was adopted by many of the current well-
established international HTA programs
CT scanner was OTA’s first target for HTA
The OTA was disbanded in 1995
Source: Oregon 2011, Sullivan 2009
13. 13
Why did these efforts fail?
First, HTA was perceived as a threat to investing in innovative
medical technologies.
Second, HTA was perceived to threaten organized medicine’s
medical autonomy.
Third, HTA was perceived to threaten access to the latest
innovations by patient advocacy groups.
Fourth, to the extent that economic evaluation was included, HTA
was seen by these stakeholders as a way to ration health care to
contain cost.
Source : Luce 2009
15. 15
Food and Drug Administration
This agency does not conduct
formal technology assessments.
Instead, FDA staff evaluates pre licensing studies of safety and
efficacy submitted by manufacturers in support of their new
drug applications.
Source: Sean, 2009
16. 16
Agency for Healthcare Research and Quality
AHRQ historically has been the largest
federal funder publicly available HTA in the United States
The most prominent federal agency that supports HTA
Key Factor Analyzed: quality, safety, efficiency and effectiveness of
healthcare
Type of Technologies :drugs, medical devices, tests, surgeries, or
ways to deliver health care
Source: Sean 2009 , Luce 2009
17. 17
Agency for Healthcare Research and Quality
Mission: AHRQ's mission is to conduct and support studies of
the outcomes and effectiveness of diagnostic, therapeutic and
preventive health care services and procedures.
The AHRQ supports HTA research primarily through three
external research networks coordinated within the Agency’s
Effective Healthcare Program.
Source: INAHTA
18. 18
Agency for Healthcare Research and Quality
The Technology Assessment (TA) Program at the AHRQ
provides technology assessments for the Centers for
Medicare & Medicaid Services (CMS).
These technology assessments are used by CMS to inform its
national coverage decisions for the Medicare program as well
as provide information to Medicare carriers.
Source: AHRQ
21. CERTsThe Centers for Education and
Research on Therapeutics
1)Drugs
2)Biological
interventions
3)Devices
22. DEcIDE
EPCs
Developing Evidence to Inform
Decisions about Effectiveness
conduct and
support
1)Treatment
appropriateness
2)Health
outcomes
3)comparative
effectiveness
24. 24
The Centers for Medicare and Medicaid Services (CMS)
The agency’s internal Coverage and
Analysis Group (CMS-CAG) conducts
technology assessments for the topics under review and issues
coverage determinations.
CMS-CAG may request formal HTAs conducted by AHRQ
For topics that involve conflicting or complex medical information,
the agency may request an independent evidence review by the
Agency for Healthcare Research and Quality (AHRQ)
Source: Pinson 2011
25. 25
Veterans Administration Technology Assessment
Program (VATAP)
VATAP is a program dedicated to advancing evidence-based
decision making, and helps senior policymakers to determine
"what works" in health care by carrying out systematic reviews
of the medical literature on health care technologies.
VATAP evaluations encompass devices, drugs, procedures,
and organizational and supportive systems used in health care.
Source: RIPSA
26. 26
Minnesota Health Technology Advisory Committee
(HTAC)
The HTAC was created in 1993
to be an objective, state-specific source of
technology evaluation for both public
and private sector decision makers.
HTAC was made up of nineteen representatives from physician
groups, technology industry representatives, health plans, and
ethicists.
The group made recommendations on emerging technologies.
Source: Wulsin 2008
27. 27
Oregon Health Resources Commission (HRC)
The OR HRC was created in 1990s
The program include criteria for
selection of the medical technologies
to be assessed.
This was the first large-scale public attempt to apply cost-
effectiveness analyses
Source: Pinson 2011
28. 28
Washington Health Technology Assessment Program
(WA-HTA)
The WA-HTA was established
in 2006
The assessments will gauge the safety
, clinical effectiveness, and cost-effectiveness of selected
technologies.
The goal is to promote the purchase of excellent health care by
investigating and paying for tests and treatments proven safe,
effective, and cost effective.
Source: wulsin 2008, Curtis 2012
29. 29
HTA Component
Program Purpose
Structure of HTA organization
Scope
Stakeholder Involvement:
Topic Nomination
HTA Products
Use of HTA in Decision Making
Source: Pinson 2011
30. 30
Program Purpose: Role of a HTA program in relationship to
policy making
Advisory with respect to evidence only
OR HRC
VATAP
Advisory with respect to evidence and policy options
MN HSAC
Authority to make coverage determinations
CMS-CAG
WA-HTA
Source: Pinson 2011
31. 31
Structure of HTA organization
Government agency
CMS-CAG
VATAP
MN HSAC
OR HRC
WA-HTA
Source: Pinson 2011
32. 32
Scope of HTAs
Source: Pinson 2011
HTA Types of Technologies Key Factors
CMS-CAG Services covered by Medicare – specific
types not specified
Effectiveness
VATAP
Vaccines, Pharmaceuticals
Devices ,Procedures
Organizational and support systems
Medical , Social
Ethical ,Economic
MN HSAC Health care services paid for by state
program
Effectiveness ,Cost
OR HRC
Pharmaceuticals ,Medical equipment and
devices , Medical or surgical procedures,
Supportive systems
Effectiveness
WA-HTA
Medical and surgical devices and
procedures , Medical equipment
Diagnostic tests
Safety ,Efficacy
Cost-effectiveness
33. 33
Stakeholder Involvement(Committees)
CMS-CAG: industry and consumer representatives, and external
subject area experts
MN HSAC: health care professional and consumer representatives
OR HRC: physician, pharmacist, hospitals, insurance, business,
labor, and consumer representatives
WA-HTA & VATAP: No information
Source: Pinson 2011
34. 34
Target Audiences
CMS-CAG: CMS – Medicare Coverage Decisions
VATAP : Senior VHA decision makers
MN HSAC: Department of Human Services
OR HRC : Oregon Health Authority
WA-HTA : State direct purchased health care program
Source: Pinson 2011
35. 35
Topic Selection
OR HRC: factors such as utilization (including overall
utilization, trends and variability in utilization) and costs
(including overall costs as well as cost variability)
WA-HTA: select topics based on technology review priorities
established in law
VATAP: No information
36. 36
Topic Selection
CMS-CAG: CMS-CAG requests HTAs for NCDs where there
is conflicting or complex medical and scientific literature
available, or when it is believed an independent analysis of
literature will be helpful for coverage decisions
MN HSAC: impact to health and budget, availability of
literature, and political relevance
Source: Pinson 2011
37. 37
Use of HTA in Decision Making
CMS-CAG: Provides advisory recommendations
VATAP : No information
MN HSAC: Summary documents as a starting point for discussion
OR HRC : Shares results of HTAs
WA-HTA : Coverage decisions based on the health technology
assessment
Source: Pinson 2011
38. 38
HTA Product
CMS-CAG: Systematic review conducted by AHRQ
VATAP : Brief Overview; bibliography
MN HSAC: Evidence summary, including proposed coverage
decision
OR HRC : Evidence summary; Brief Clinician Summaries
WA-HTA : Health technology assessments; findings and coverage
decisions
Source: Pinson 2011
39. 39
Criteria to prioritize and select topics(WA-HTA)
Concerns about its safety, efficacy, or cost-effectiveness,
especially relative to existing alternatives, or significant
variations in its use
Actual or expected state expenditures are high, due to demand
for the technology, its cost, or both
Adequate evidence available to conduct the complete review
Source: Pinson 2011
40. 40
Secondary criteria(WA-HTA)
Number of persons affected per year
Severity of condition treated by technology
Policy related urgency
Diffusion concern
Potential or observed variation
Special populations
Ethical concerns
Source: Pinson 2011
41. 41
formal health technology assessment process
I. Horizon scanning
II. Topic determination and queuing
III. Collection and assessment of evidence
IV. Funding and policy implementation
42. 42
Horizon scanning involves the early examination and
active monitoring of emerging technology to determine, in
part, potential evidence requirements, and budgetary
implications.
Topic determination and queuing activities focus on
setting priorities and sequencing of emerging and
previously considered technologies for assessment or
reassessment.
The assessment function entails the process of
collecting, evaluating, and systematically reviewing all
available evidence for the technology under consideration.
43. 43
Appraisal is the decision-making function and is often
distinguished by an external body (e.g., a pharmacy and
therapeutics committee in the United States) that considers and
weighs the summarized evidence in order to render a
recommendation to the payer.
Funding and policy implementation are the final steps in the
HTA process.