Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Looking Forward: Forum Activities in 2021 and Beyond Forum Membership Meetings In 2021, the forum membership will 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 activities outlined in the following sections. The biological, physical, and digital spheres are merging; Workshops clinical research and health care Envisioning a Transformed Clinical Trials Enterprise: Establishing an Agenda for 203032 are at a critical juncture; Clinical trials research has changed dramatically over the past decade. The and new technologies enable biological, physical, and digital spheres are merging; clinical research and health the collection of data in 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 real-world settings. 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 from across the clinical research lifecycle, including patients, caregivers, sponsors, technologists, regulators, practitioners, and researchers, to examine the challenges and setbacks, 26 lessons learned, and advances from the past decade and consider the challenges
Looking Forward: Forum Activities in 2021 and Beyond Forum members Tanisha Carino and Luther Clark chat after the March 2019 forum meeting. and opportunities that may be coming over the next 10 years. On January 26, February 9, March 24, and May 11, 2021, the forum will convene a public workshop to discuss how to better integrate community practice and clinical trials, improve patient engagement in clinical trials, align cultural and financial incentives, and better support the clinical trials infrastructure. The workshop will provide a venue to consider a transformed clinical trial enterprise for 2030 and discuss the goals and key priorities for advancing a clinical trials enterprise that is more efficient, effective, person-centered, inclusive, and integrated into the health care delivery system of 2030 Improving the Evidence Base for Treating Older Adults with Cancer33 As the U.S. population ages, the overall number of individuals diagnosed with cancer is increasing and older adults also account for a growing proportion of both 32 For more information and updates on this project, see https://www.nationalacademies.org/our-work/ envisioning-a-transformed-clinical-trials-enterprise-for-2030-a-workshop. 33 For more information and updates on this project, see https://www.nationalacademies.org/event/01-22-2021/ improving-the-evidence-base-for-treatment-decision-making-for-older-adults-with-cancer-a-workshop. 27
cancer diagnoses and cancer deaths. Clinicians, along with patients with cancer, and their families rely on clinical research for information on the potential benefits and harms of different treatment options so that they can make informed treatment decisions that are consistent with the patientsâ needs, values, and preferences. However, the evidence base for older adults with cancer is limited by a pervasive underrepresentation of this population in cancer clinical trials. To begin to address these issues, the forum, along with the National Cancer Policy Forum and the Forum on Aging, Disability, and Independence, will host an FDA-sponsored, public workshop on January 22, 25, and 27, 2021. This workshop will aim to illuminate a path forward in generating meaningful evidence for the treatment of older adults with cancer. Innovation in Drug Research and Development for Prevalent Chronic Diseases34 Chronic diseases such as heart disease, stroke, cancer, and diabetes are the leading cause of death and disability among Americans and a major factor in the nationâs rapidly increasing health care costs. At present, 6 in 10 U.S. adults live with at least one chronic disease, and 4 in 10 have two or more. However, despite the human and financial costs of chronic diseases, investment in the disorders has not kept pace with the need. On February 22 and March 1 and 8, 2021, the forum will host a public workshop to examine and highlight the bottlenecks to innovation in drug R&D for prevalent chronic diseases and consider the challenges and opportunities for spurring drug R&D in this space. Accelerating the Development of Rapid Diagnostics to Address Antibiotic Resistance The use and misuse of antibiotics contributes to the rise in drug-resistant bacteriaâ a serious and worsening threat to human health. Addressing the problem of antibiotic resistance requires measures to spur innovation and ensure the prudent use of existing drugs. Rapid diagnostics can play an important role in avoiding the unnecessary use of antimicrobials by providing clinicians with the right information 34 For more information and updates on this project, see https://www.nationalacademies.org/event/02-22-2021/ innovation-in-drug-research-and-development-for-prevalent-chronic-diseases-a-virtual-workshop. 28
Looking Forward: Forum Activities in 2021 and Beyond Attendees at the 2018 workshop, Advancing the Science of Patient Input in Medical Product R&D, participate in at the right time to help them make decisions about appropriate drug treatment small group discussions. for patients, have the capacity to support early detection and diagnosis of drug- resistant bacterial infections, enable disease surveillance, and help prevent disease spread. Participants in this public workshop will discuss the current landscape of rapid diagnostics to address antibiotic resistance, consider the challenges and opportunities for spurring innovation, and discuss practical next steps for accelerating the development of new diagnostic tools. 29
