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How Do You Build A Clinical Trial Network Focused On Diversity?

Executive Summary

Stakeholders discuss network models, barriers to their creation, and what is needed for them to be successful at PhRMA meeting.

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Clinical Trial Diversity: Data Points to Structural, Not Patient-Specific Solutions

Minorities are more likely to participate in cancer clinical trials than white people, but they are less likely to get the chance to say yes, highlighting the importance of bringing studies to different locations if sponsors are to be successful at increasing diversity.

Reducing Clinical Trial Burdens Brings Greater Participant Diversity – PhRMA

Industry principles for enhancing diversity in clinical trials call for use of digital data collection tools and flexible scheduling of study site visits to reduce barriers to enrollment, as well as greater involvement of under-represented communities in the trial design planning process and recruitment of investigators with diverse ethnic and racial backrounds.

US FDA’s Confidentiality Policies Seen As Big EUA Shortcoming

System needs to be changed to enable US FDA to share COVID-19 application data and inspection reports with other regulatory authorities, stakeholders urge. Merck’s Julie Gerberding and former FDA Commissioner Hamburg criticize company announcement of data via press release prior to submission.

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