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Message from the Co- hairsâ C Russ Altman and Robert Califf We have entered an exciting phase of biomedical researchâa time when the biological, physical, and digital spheres are merging; clinical research and health care are at a critical juncture; and new technologies enable the collection of data The Forum serves as a hub in real-world settings. These opportunities hold great promise for advancing our understanding of health maintenance and prevention, disease progression, and and a catalyst for nurturing developing new therapies for patients. new ideas and partnerships Clinical trials remain a cornerstone of medical product development by providing and offers a neutral space the scientific evidence that proves or disproves concepts developed during earlier for stakeholders to advance stages of development about the safety and efficacy of medical products and by critical policy discussions on informing clinical care. At the same time, the clinical research enterprise faces continued and mounting pressures, strained from all sides by rising costs, an biopharmaceutical innovation evolving regulatory and economic landscape, increasing clinical trial complexity, nationally and globally. difficulties in the recruitment and retention of research participants, and a clinical research workforce that is under tremendous stress. These challenges cannot be overcome in isolation and will require collaboration among patients, providers, academia, industry, federal agencies, payers, nonprofit organizations, and funders. The Forum on Drug Discovery, Development, and Translation (the Forum) of the National Academies of Sciences, Engineering, and Medicine (the National Academies) was created in 2005 by the National Academiesâ Board on Health Sciences Policy to foster communication, collaboration, and action in a neutral setting on issues of mutual interest across the drug research and development (R&D) lifecycle. The Forum membership includes leaders from the National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA), the biopharmaceutical industry, academia, consortia, foundations, journals, and patient-focused and disease advocacy organizations. Through the Forumâs activities, participants have been better able to bring attention and visibility to important issues, explore new approaches for resolving problem areas, share information and find common ground, and work together to develop ideas into concrete actions and new collaborations.
In 2018, the Forum completed a three-part workshop series that explored a forward-looking agenda for generating and incorporating real-world evidence into medical product development and evaluation. The Forum also hosted the workshop Advancing the Science of Patient Input in Medical Product R&D: Towards a Research Agenda, which examined the barriers and opportunities for converting traditionally anecdotal patient input into rigorous, credible evidence to inform Russ Altman medical product decision making in a way that is meaningful for patients. To explore Co-Chair opportunities for a modern, patient-centric clinical trials enterprise in light of digital health tools, the Forum hosted the workshop Virtual Clinical Trials: Challenges and Opportunities. Among its membership, the Forum discussed emerging and pertinent science and policy issues relevant to drug discovery, development, and translation. In 2019, more work is needed to spur biomedical innovation in a responsible manner and to ensure that research is adequately powered to answer real questions about the safety and effectiveness of medical products. The executive and legislative branches of the federal government have continued to show bipartisan support for biomedical research, including ongoing funding for programs such as the BRAIN Initiative, the Precision Medicine Initiative, and the 21st Century Cures Act. Government funders and regulators of biomedical research, such as FDA and NIH, stand to receive continued infusions of funding and support for relevant programmatic priorities. Robert Califf Co-Chair The Forum serves as a hub and a catalyst for nurturing new ideas and partnerships and offers a neutral space for stakeholders to advance critical policy discussions on biopharmaceutical innovation nationally and globally. Looking ahead to 2019, the Forum plans to focus on important issues such as advancing the science of patient input in medical product R&D, enhancing the reproducibility of biomedical research through transparent reporting, spurring innovation for prevalent chronic diseases, and accelerating progress toward clinical trial data sharing. We look forward to another groundbreaking and productive year for the Forum in 2019.
Forum members at the 41st Forum meeting held in October 2018.
Contents Reflecting Back: Forum Activities in 2018 6 Looking Forward: Forum Activities in 2019 11 Action Collaboratives 14 Forum Themes and Priorities 18 Forum Sponsorship and Membership 22 Timeline 24
