DIA and FDA Office of Women’s Health (OWH) Present: Partnerships to Advance Patient Recruitment an

Venue: Hilton Rockville Hotel

Location: Rockville, Maryland, United States

Event Date/Time: Oct 14, 2010 End Date/Time: Oct 15, 2010
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DIA and FDA Office of Women’s Health OWH) are pleased to announce the first FDA-cosponsored patient recruitment and retention conference to broaden the understanding and solution-driven discussion for:
• FDA, industry and academia collaborate and dialogue on challenges and solutions for adequate patient demographics in clinical research through enhanced recruitment and retention strategies
• Reach consensus on issues, potential solutions and accountable resources
• Increase awareness and educate stakeholders on the critical need to include diversity and sub group populations in clinical trials
• Summarize major obstacles that can be overcome, solutions that can be adopted and demonstrate tools of success
• Identify who is doing what in the area of recruitment and retention and explore partnerships and collaborations between organizations
• Discuss future plans to revisit recruitment and retention issues in clinical research
• Generate a white paper

Joshua M. Sharfstein, MD
Vivian W. Pinn, MD

Recruiting adequate numbers of clinical trial participants has always been difficult across diverse populations particularly in women, children, ethnic minorities and the aging sub-group populations. It is well-known and scientifically documented that different medicines affect these populations differently. Therefore, more inclusive protocols, plans and strategies are imperative in order to address known barriers and uncover others in order to facilitate and expedite enrollment of underrepresented populations.

This conference will allow key stakeholders including pharmaceutical companies, CROs, principal investigators, physicians, government, research institutions, and IRBs to engage in shared discussions and establish action plans eliminating disparities and advancing representation of sub-populations in clinical drug trials. The conference will focus on multi-factorial issues including:
1. Recruitment and retention barriers and motivations for different subgroup populations in clinical trials;
2. Regulatory and public health impact of under-representation of women, elderly and minority groups in clinical trials;
3. Current industry, CROs, principal investigators and research institutions practices to ensure adequate recruitment and retention of patients in clinical trials;
4. Innovative and successful solutions/strategies for recruiting and retaining diverse populations in clinical trials.

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