the broader public (including patients and communities) and medical professionals (community physicians and those practicing in academic medical centers) in the clinical trial enterprise is a significant challenge.
In light of these current challenges to clinical trials in the United States, this collaboration between the IOM Forum on Drug Discovery, Development, and Translation and Mount Sinai School of Medicine seeks to engage stakeholders and experts in an open discussion of current challenges and potential solutions to improving the capacity for efficient conduct of clinical trials in the United States through enhancing public engagement.
• Define and discuss the problem of inadequate public engagement in clinical trials.
• Identify the structures and culture of health care systems and delivery organizations that fail to support or engage with the clinical trial enterprise and suggest potential solutions for how health centers can be engaged to support the clinical trial enterprise.
• Discuss how academic medical centers can create successful community partnerships to improve public engagement in clinical trials.
• Highlight and discuss models/methods, both proven and yet to be tried, of public engagement. Address the media’s role in public engagement.
• Describe novel clinical trial designs (such as adaptive clinical trial designs) that minimize enrollment needs and address treatment assignment concerns of physicians and their patients.
• Involve stakeholders in a discussion of moving forward to create a comprehensive strategy for enhanced public engagement in clinical trials.
SESSION I: FRAMING THE PROBLEM
Moderator: Jeffrey Drazen, Co-Chair, Forum on Drug Discovery, Development and Translation, New England Journal of Medicine
• Provide a definition of “engagement,” both public and professional, in clinical trials.
• Survey the current landscape in terms of deficiencies in public and professional engagement, and discuss consequences of this lack of engagement.
• Identify gaps/areas of particular need, desired outcomes of enhanced engagement, and the challenges facing this progress.