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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.
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.
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.
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.
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.
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
In response to the coronavirus disease 2019 (COVID-19) pandemic and the societal disruption it has brought, national governments and the international community have invested billions of dollars and immense amounts of human resources to develop a safe and effective vaccine in an unprecedented time frame. Vaccination against this novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), offers the possibility of significantly reducing severe morbidity and mortality and transmission when deployed alongside other public health strategies and improved therapies. Health equity is intertwined with the impact of COVID-19 and there are certain populations that are at increased risk of severe illness or death from COVID-19. In the United States and worldwide, the pandemic is having a disproportionate impact on people who are already disadvantaged by virtue of their race and ethnicity, age, health status, residence, occupation, socioeconomic condition, or other contributing factors. Framework for Equitable Allocation of COVID-19 Vaccine offers an overarching framework for vaccine allocation to assist policy makers in the domestic and global health communities. Built on widely accepted foundational principles and recognizing the distinctive characteristics of COVID-19, this report's recommendations address the commitments needed to implement equitable allocation policies for COVID-19 vaccine.
The National Academies of Sciences, Engineering, and Medicine held a workshop on August 22â€"23, 2018, in Washington, DC, to explore medical and public health preparedness for a nuclear incident. The event brought together experts from government, nongovernmental organizations, academia, and the private sector to explore current assumptions behind the status of medical and public health preparedness for a nuclear incident, examine potential changes in these assumptions in light of increasing concerns about the use of nuclear warfare, and discuss challenges and opportunities for capacity building in the current threat environment. This publication summarizes the presentations and discussions from the workshop.
Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. The book is designed not only for biopharmaceutical professionals, such as statisticians, safety specialists, pharmacovigilance experts, and pharmacoepidemiologists, who can use the book as self-learning materials or in short courses or training programs, but also for graduate students in statistics and biomedical data science for a one-semester course. Each chapter provides supplements and problems as more readings and exercises.