The field of endeavors known as "regulatory science" has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, and other specific scientific disciplines whose focus, aggregation, and ultimate implementation could inform biomedical product development and regulatory decision making. Substantial efforts have been devoted to defining regulatory science and communicating its value and role across the scientific and regulatory ecosystems. Investments are also being made in technology infrastructure, regulatory systems, and workforce development to support and advance this burgeoning discipline. In October 2015, the National Academies of Sciences, Engineering, and Medicine held a public workshop to facilitate dialogue among stakeholders about the current state and scope of regulatory science, opportunities to address barriers to the discipline's success, and avenues for fostering collaboration across sectors. Participants explored key needs for strengthening the discipline of regulatory science, including considering what are the core components of regulatory science infrastructure to foster innovation in medical product development. This report summarizes the presentations and discussions from the workshop.

The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.

Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.

This is a print on demand edition of a hard to find publication. Recent breakthroughs in science and tech. -- ranging from sequencing of the human genome to advances in the application of nanotech. to new medical products -- may transform our ability to prevent, diagnose and treat disease. Similarly, advances in research and IT enable us to more efficiently identify microbial pathogens, track food contamination outbreaks and determine where foods and other FDA-regulated products are produced or manufactured, how they are transported, where they go and who uses them. This report outlines a broad vision for advancing regulatory science and unleashing its potential to improve public health. It discusses the role of the FDA to strengthen the field, both within the agency and throughout the Nation. Illustrations.

The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

In the last several decades, there has been a surge of interest in expertise in the social scientific, philosophical, and legal literatures. While it is tempting to attribute this surge of interest in expertise to the emergence and consolidation of a "knowledge society," "post-industrial society," or "network society," it is more likely that the debates about expertise are symptomatic of significant change and upheaval. As the number of contenders for expert status has increased, as the bases for their claims have become more diverse, and as the struggles between these would-be experts intensified, expertise became problematic and contested. In The Oxford Handbook of Expertise and Democratic Politics, Gil Eyal and Thomas Medvetz have brought together a broad group of scholars who have engaged substantively and theoretically with debates regarding the nature of expertise and the social roles of experts to examine these areas within sociology and allied disciplines. The analyses take an historical and relational approach to the topic and are motivated by the sense that growing mistrust in experts represents a danger to democratic politics today. Among the topics considered here are the value and relevance of the boundary between experts and laypeople; the causes and consequences of mistrust in experts; the meanings and social uses of objectivity; and the significance of recent transformations in the organization of the professions. Bringing together investigations from social scientists, philosophers, and legal scholars into the political dimensions of expertise, this Handbook connects interdisciplinary work done in science and technology studies with the more classic concerns, topics, and concepts of sociologists of professions and intellectuals.

The volume and complexity of information about individual patients is greatly increasing with use of electronic records and personal devices. Potential effects on medical product development in the context of this wealth of real-world data could be numerous and varied, ranging from the ability to determine both large-scale and patient-specific effects of treatments to the ability to assess how therapeutics affect patients' lives through measurement of lifestyle changes. In October 2016, the National Academies of Sciences, Engineering, and Medicine held a workshop to facilitate dialogue among stakeholders about the opportunities and challenges for incorporating real-world evidence into all stages in the process for the generation and evaluation of therapeutics. Participants explored unmet stakeholder needs and opportunities to generate new kinds of evidence that meet those needs. This publication summarizes the presentations and discussions from the workshop.