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Reflecting Back: Forum Activities in 2019 Members of the Forum convene Forum Membership Meetings In 2019, the Forum membership focused on diverse topics related to the Forumâs several times each year to priorities, including issues for emerging biotech companies; transforming clinical identify, discuss, and act on key trials through digital health; improving the drug development process through problems and strategies in the examining late-stage failures; real-world evidence and medical product development; harmonizing clinical trial site standards; data-sharing principles for nonprofit clinical discovery, development, and trial funders; the science of patient input in medical product R&D; innovative models translation of drugs. to spur translational research and drug discovery; artificial intelligence applications for drug discovery and development; and other policy updates relevant to drug discovery, development, and translation. To supplement the perspectives and expertise of its members, the Forum holds public workshops to focus attention on critical areas of drug development. Summaries of these meetings are disseminated to the public through the Forum website and published proceedings. Workshops and Meetings Updating Labels for Generic Oncology Drugs: A Meeting The Forum, in collaboration with the National Academiesâ National Cancer Policy Forum, hosted a public meeting, sponsored by FDA, on March 26, 2019, that convened expert stakeholders to discuss the challenges and opportunities for updating labels for generic oncology drugs. The meeting featured discussions about current regulatory requirements for labeling updates, review processes for clinical practice guidelines for oncology, and how outdated drug labeling can impact clinical care. Meeting participants considered potential sources of data and evidentiary 6
Reflecting Back: Forum Activities in 2019 Freda Lewis-Hall, Deborah Hung, and Robert Califf (from left to right) share their thoughts during the 43rd Forum meeting held in July 2019. standards to guide decision making for labeling updates, including indications for select patient populations (e.g., pediatric oncology), dosing, and adverse events. Enhancing Scientific Reproducibility Through Transparent Reporting: A Workshop In collaboration with the National Academiesâ Forum on Neuroscience and Nervous System Disorders, National Cancer Policy Forum, and Roundtable on Genomics and Precision Health, the Forum convened a workshop on September 25â26, 2019, to examine the current state of transparency in reporting biomedical research (e.g., disclosure of the availability and location of data, materials, analysis, and methodology) and to explore the possibility of improving the harmonization of guidelines across journals and funding agencies so that biomedical researchers propose and report data in a consistent manner. Workshop participants discussed the challenges and opportunities for the harmonization of guidelines for transparent reporting throughout the biomedical research lifecycle. The agenda included a panel discussion on facilitating the development of consistent guidelines (e.g., a common set of minimal reporting standards) that could be applied across journals and funders 7
to increase transparency in proposing and reporting biomedical research. This workshop was sponsored by NIH, Cell Press, The Lancet, and Nature Research. Sharing Clinical Trial Data: Challenges and a Way Forward: A Workshop In collaboration with the National Academiesâ Forum on Neuroscience and Nervous System Disorders, National Cancer Policy Forum, and Roundtable on Genomics and Precision Health, the Forum hosted a public workshop to examine the progress and remaining gaps in clinical trial data sharing following the publication of the 2015 Institute of Medicine (IOM) report Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Workshop participants considered the value and potential risks/ costs of sharing clinical trial data for key stakeholders, including clinical trialists, sponsors, primary and secondary researchers, and patients. The agenda featured use cases from across public and private sectors when it comes to success, failure, lessons learned, and the value of data sharing. This workshop was sponsored by the Wellcome Trust. 8
Reflecting Back: Forum Activities in 2019 Participants discuss actions stakeholders could take to improve transparent reporting of biomedical research during a 2019 workshop on Enhancing Scientific Reproducibility Through Transparent Reporting. 9
