Forum on Drug Discovery, Development, and Translation: 2019 Annual Report (2020)

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Looking Forward: Forum Activities in 2020 Forum Membership Meetings The Forum membership will meet in March, July, and October 2020 to continue its discussions of key problems and strategies in the discovery, development, and translation of drugs. Forum workshop planning committees, working groups, and Action Collaboratives will convene to discuss and act on identified priority areas, including the following activities. Workshops and Meetings The Role of Digital Health Technologies in Drug Development Digital health technologies (e.g., smartphone apps, wearable sensors, and other remote, sensor-based tools that combine hardware and software) have become increasingly available to consumers, providers, and researchers. They offer new opportunities to address critical challenges or “pain points,” better connect patients and health care providers, and incorporate patient input throughout the drug R&D lifecycle. In collaboration with the National Academies’ Roundtable on Genomics and Precision Health, the Forum will host a workshop on March 24, 2020, to discuss the challenges and opportunities in using digital health technologies to improve the probability of success in drug development. Workshop participants may consider key components for an evidence-based framework for applying digital health technologies toward drug R&D. 10 

Participants at the 2019 workshop on Sharing Clinical Trial Data: Challenges and a Way Forward. 11 

Drug Research and Development for Older Adult Populations Despite the widespread recognition of the “graying of America,” and the need for health care among older adults, there is a dearth of information about the appropriate use of drugs in this population. Older adults are vastly underrepresent- ed in clinical trials. Yet, older adults have higher rates of comorbidities and polypharmacy than the general population and are the majority users of many medications. Additionally, age-related physiological and pathological changes, particularly for adults over age 80, can lead to significant differences in the pharmacokinetic and pharmacodynamics of a given drug compared to the general population. There is a void in evidence-based information for making informed decisions on how to best optimize care for older adults,particularly those over age 80. In collaboration with the National Academies’ Forum on Aging, Disability, and Independence and the National Academies’ National Cancer Policy Forum, the Forum will host a workshop to discuss the challenges and opportunities in drug R&D for the over age 65 and over age 80 populations, explore barriers that impede safety and efficacy studies in these populations, and share lessons learned and best practices for better understanding the clinical pharmacology for older adults. Envisioning a Transformed Clinical Trials Enterprise for 2030 Clinical trials research has changed dramatically over the past decade. 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 in real-world settings. These opportunities hold great promise for advancing our understanding of health maintenance and prevention, disease progression, and developing new therapies for patients. At the same time, the clinical research enterprise faces continued and mounting pressures, strained from all sides by rising costs, an evolving regulatory and economic landscape, increasing clinical trial complexity, difficulties in the recruitment and retention of research participants, and a clinical research workforce that is under tremendous stress. Some, but not all, of these challenges and opportunities were predicted in the 2011 Forum- hosted workshop Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020. There is now a need for stakeholders 12 

Looking Forward: Forum Activities in 2020 from across the clinical research lifecycle, including patients, caregivers, regulators, Forum members (from left to right) Ross practitioners, and researchers, to examine the challenges and setbacks, lessons learned, McKinney, Jr., Anantha Shekhar, Bernard Munos, and Ann E. Taylor sharing their and advances from the past decade, and consider the challenges and opportunities that thoughts at the July 2019 Forum meeting. may be coming over the next 10 years. Workshop discussions will focus broadly on how to better integrate community practice and clinical trials, improve patient engagement in clinical trials, align cultural and financial incentives, and support the clinical trials infrastructure. The workshop will provide a venue to discuss goals and key priorities for advancing a clinical trials enterprise that is more efficient, effective, patient-centered, and integrated into the health delivery system of 2030. 13