Characterizing And Communicating Uncertainty In The Assessment Of Benefits And Risks Of Pharmaceutical Products

Download or read book Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products written by Institute of Medicine and published by National Academies Press. This book was released on 2014-12-19 with total page 123 pages. Available in PDF, EPUB and Kindle. Book excerpt: Despite the extensive body of evidence that informs regulatory decisions on pharmaceutical products, significant uncertainties persist, including the underlying variability in human biology, factors associated with the chemistry of a drug, and limitations in the research and clinical trial process itself that might limit the generalizability of results. As a result, regulatory reviewers are consistently required to draw conclusions about a drug's safety and efficacy from imperfect data. Efforts are underway within the drug development community to enhance the evaluation and communication of the benefits and risks associated with pharmaceutical products, aimed at increasing the predictability, transparency, and efficiency of pharmaceutical regulatory decision making. Effectively communicating regulatory decisions necessarily includes explanation of the impact of uncertainty on decision making. On February 12 and May 12, 2014, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation held public workshops to advance the development of more systematic and structured approaches to characterize and communicate the sources of uncertainty in the assessment of benefits and risks, and to consider their implications for pharmaceutical regulatory decisions. Workshop presentations and discussions on February 12 were convened to explore the science of identifying and characterizing uncertainty in scientific evidence and approaches to translate uncertainties into decisions that reflect the values of stakeholders. The May 12 workshop presentations and discussions explored tools and approaches to communicating about scientific uncertainties to a range of stakeholders in the drug development process. Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products summarizes the presentation and discussion of both events. This report explores potential analytical and communication approaches and identifies key considerations on their development, evaluation, and incorporation into pharmaceutical benefit- risk assessment throughout the entire drug development lifecycle.

Download or read book Benefit-Risk Assessment Methods in Medical Product Development written by Qi Jiang and published by CRC Press. This book was released on 2017-12-19 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: Guides You on the Development and Implementation of B–R Evaluations Benefit–Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments provides general guidance and case studies to aid practitioners in selecting specific benefit–risk (B–R) frameworks and quantitative methods. Leading experts from industry, regulatory agencies, and academia present practical examples, lessons learned, and best practices that illustrate how to conduct structured B–R assessment in clinical development and regulatory submission. The first section of the book discusses the role of B–R assessments in medicine development and regulation, the need for both a common B–R framework and patient input into B–R decisions, and future directions. The second section focuses on legislative and regulatory policy initiatives as well as decisions made at the U.S. FDA’s Center for Devices and Radiological Health. The third section examines key elements of B–R evaluations in a product’s life cycle, such as uncertainty evaluation and quantification, quantifying patient B–R trade-off preferences, ways to identify subgroups with the best B–R profiles, and data sources used to assist B–R assessment. The fourth section equips practitioners with tools to conduct B–R evaluations, including assessment methodologies, a quantitative joint modeling and joint evaluation framework, and several visualization tools. The final section presents a rich collection of case studies. With top specialists sharing their in-depth knowledge, thought-provoking considerations, and practical advice, this book offers comprehensive coverage of B–R evaluation methods, tools, and case studies. It gives practitioners a much-needed toolkit to develop and conduct their own B–R evaluations.

Download or read book Multi-Criteria Decision Analysis to Support Healthcare Decisions written by Kevin Marsh and published by Springer. This book was released on 2017-04-18 with total page 326 pages. Available in PDF, EPUB and Kindle. Book excerpt: Representing the first collection on the topic, this book builds from foundations to case studies, to future prospects, providing the reader with a rich and comprehensive understanding of the use of multi-criteria decision analysis (MCDA) in healthcare. The first section of the collection presents the foundations of MCDA as it is applied to healthcare decisions, providing guidance on the ethical and theoretical underpinnings of MCDA and how to select MCDA methods appropriate to different decision settings. Section two comprises a collection of case studies spanning the decision continuum, including portfolio development, benefit–risk assessment, health technology assessment, priority setting, resource optimisation, clinical practice and shared decision making. Section three explores future directions in the application of MCDA to healthcare and identifies opportunities for further research to support these.

Download or read book Characterizing Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products written by and published by . This book was released on 2014 with total page 7 pages. Available in PDF, EPUB and Kindle. Book excerpt: On February 12, 2014, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation held a public workshop as the first of a two-part series to advance the development of more systematic and structured approaches to characterize and communicate the sources of uncertainty in the assessment of benefits and risks, as well as their implications for pharmaceutical regulatory decisions. Workshop presentations and discussions were convened to explore the science of identifying and characterizing uncertainty in scientific evidence and approaches to translate uncertainties into decisions that reflect the values of stakeholders. This brief summary of the workshop provides highlights from the presentations and discussions.

Download or read book The Science of Science Communication III written by National Academy of Sciences and published by National Academies Press. This book was released on 2018-06-01 with total page 119 pages. Available in PDF, EPUB and Kindle. Book excerpt: Successful scientists must be effective communicators within their professions. Without those skills, they could not write papers and funding proposals, give talks and field questions, or teach classes and mentor students. However, communicating with audiences outside their profession - people who may not share scientists' interests, technical background, cultural assumptions, and modes of expression - presents different challenges and requires additional skills. Communication about science in political or social settings differs from discourse within a scientific discipline. Not only are scientists just one of many stakeholders vying for access to the public agenda, but the political debates surrounding science and its applications may sometimes confront scientists with unfamiliar and uncomfortable discussions involving religious values, partisan interests, and even the trustworthiness of science. The Science of Science Communication III: Inspiring Novel Collaborations and Building Capacity summarizes the presentations and discussions from a Sackler Colloquium convened in November 2017. This event used Communicating Science Effectively as a framework for examining how one might apply its lessons to research and practice. It considered opportunities for creating and applying the science along with the barriers to doing so, such as the incentive systems in academic institutions and the perils of communicating science in polarized environments. Special attention was given to the organization and infrastructure necessary for building capacity in science communication.

Download or read book Insights in Regulatory Science: 2021 written by Bruno Sepodes and published by Frontiers Media SA. This book was released on 2022-11-04 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Risk Assessment Methods for Biological and Chemical Hazards in Food written by Fernando Pérez-Rodríguez and published by CRC Press. This book was released on 2020-10-28 with total page 547 pages. Available in PDF, EPUB and Kindle. Book excerpt: Risk assessment has been extensively developed in several scientific fields, such as environmental science, economics, and civil engineering, among others. In the aftermath of the SPS and GATT agreements on the use of risk analysis framework in food trade, signed in the 1990s, international organisations and governments adopted risk assessment as a science-based process to ensure food safety along the food chain. The food industry can also benefit from the use of this approach for food process optimisation and quality assurance. Risk Assessment Methods for Biological and Chemical Hazards in Food introduces the reader to quantitative risk assessment methods encompassing general concepts to specific applications to biological and chemical hazards in foods. In the first section, the book presents food risk assessment as methodology and addresses, more specifically, new trends and approaches such as the development of risk rating methods, risk metrics, risk-benefit assessment studies and quality assessment methods. Section II is dedicated to biological hazards. This section identifies the most relevant biological hazards along the food chain and provides an overview on the types of predictive microbiology models used to describe the microbial response along the food chain. Chapter 12 specifically deals with cross contamination and the quantitative methods that can be applied to describe this relevant microbial process. The development and application of dose-response models (i.e. mathematical function describing the relationship between pathogen dose and health response) are also covered in this section. In Section III, the book translates risk assessment concepts into the area of chemical hazards, defining the process steps to determine chemical risk and describing the uncertainty and variability sources associated with chemicals. Key Features: Presents new trends and approaches in the field of risk assessment in foods Risk assessment concepts are illustrated by practical examples in the food sector Discusses how quantitative information and models are integrated in a quantitative risk asssment framework Provides examples of applications of quantitative chemical risk assessment in risk management The book, written by renowned experts in their field, is a comprehensive collection of quantitative methods and approaches applied to risk assessment in foods. It can be used as an extensive guide for food safety practitioners and researchers to perform quantitative risk assessment in foods