Forum on Drug Discovery, Development, and Translation: 2014 Annual Report (2015)

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Reflecting Back Forum Activities in 2014 Forum Meetings The Forum membership met three times in 2014. Discussions at these meet- ings focused on diverse topics relating to the Forum’s priorities, including establishing a clinical trials network and enhancing clinical trial infrastruc- ture; envisioning the translational science and drug development enterprise of the future; challenges in biomedical innovation; best practices and metrics for collaboration; mapping the biomedical innovation ecosystem; and strat- egies for responsible sharing of clinical trial data. In addition, the Forum convened public workshops and collaborative meetings, described below. Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products—Workshop Series (February and May 2014) There is increasing attention to the need for enhancing the evaluation and communication of the benefits and risks associated with pharmaceutical products, thereby increasing the predictability, transparency, and efficiency of pharmaceutical regulatory decision making. An extensive body of evi- dence informs regulatory decisions on the safety and efficacy of a proposed product, but in many cases, FDA must draw conclusions from imperfect data. This two-part public workshop series was convened at the request of FDA to address the opportunity to advance the development of more systematic and structured approaches to characterize and communicate: (a) the sources of uncertainty in the assessment of benefits and risks; and (b) their implica- tions for pharmaceutical regulatory decisions. Specifically, the workshops explored potential analytical and communication approaches and identified key considerations for their development, evaluation, and incorporation into the assessment of benefits and risks in pharmaceuticals. The workshop was covered in a story on NPR’s All Things Considered, and workshop attendees FORUM ACTIVITIES TIMELINE 2000–2004 2005 Clinical Research Roundtable, predecessor to the Drug Forum 

Reflecting Back: Forum Activities in 2014 will create a Perspective paper summarizing the results of an innovative media analysis presented at the workshop. Clinical Trial Site Standards Harmonization—Action Collaborative (March 2014) Since sponsoring a workshop series on issues relating to the U.S. national clini- cal trials enterprise from 2009 to 2011, the Forum continues to devote time and attention to issues around clinical trials. This action collaborative is an ad hoc convening activity under the auspices of the Forum, which provides a venue for joint and collaborative activities among participants to advance development of standards or a system to improve clinical trial performance through accredita- tion of clinical trial sites. Participants, who are drawn from multiple sectors and disciplines, are preparing a Perspective paper, to be posted by the IOM, which will summarize their perspectives on a process for standards development, and on the establishment of a mechanism to facilitate coordination of an experimen- tal approach to align existing standards and improve clinical trial site standards based on continuous data collection. Collaborative participants are also plan- ning a second phase of the collaborative activity, which is expected to include the collection, analysis, and assessment of how clinical trial site standards that are currently in use by key stakeholders could be harmonized. March 23–24 June 29–30 September 8–9 Forum Meeting #1 Forum Meeting #2 Forum Meeting #3