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Looking Forward: Forum Activities in 2019 Forum Membership Meetings The Forum membership will meet in March, July, and October 2019 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 Updating Labels for Generic Oncology Drugs: A Meeting The Forum, in collaboration with the National Academiesâ National Cancer Policy Forum, will host a public meeting, sponsored by FDA, on March 26, 2019. Participants at this meeting will examine the challenges and opportunities for updating labels for generic oncology drugs. The meeting may include discussions on current FDA guidelines regarding the quality and quantity of evidence required to support claims of safety and effectiveness in new drug applications. Additionally, meeting participants may discuss potential criteria and sources of data to guide decision making for generic label updates on indications, dosing, and adverse events, and approaches for addressing specific gaps in labeling, such as for certain patient populations (e.g., pediatric) and for cross-labeling combination therapies. Forum staff Amanda Wagner Gee listening to co-chairs (left to right) Russ Altman and Robert Califf at the March 2018 Forum meeting. 11
Enhancing Scientific Reproducibility Through Transparent Reporting: A Workshop The Forum will convene a workshop on September 25â26, 2019, exploring issues related to transparent reporting (e.g., the disclosure of the availability and location of data, materials, analysis, and methodology) to improve rigor and reproducibility in biomedical research. Workshop attendees will discuss the challenges and op- portunities for the harmonization of guidelines for transparent reporting throughout the biomedical research lifecycle. The agenda will include 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 to increase transparency in proposing and reporting biomedical research. Sharing Clinical Trial Data: Reflecting Back and Looking Ahead: A Workshop This workshop will 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. The public work- shop will examine the recent advances, remaining challenges, and new opportu- nities in clinical trial data sharing. Workshop presentations and discussions may include case studies and trends in clinical trial data sharing and reuse as well as the consideration of best practices and lessons learned. 12
Looking Forward: Forum Activities in 2019 Forum members (from left to right) Jeff Hurd, Gregory Keenan, and Joseph Menetski sharing their thoughts at the March 2018 Forum meeting. 13
