In the Spotlight
Last Call! Register now for the 2023 Annual Meeting in Boston, December 13-14
Schedule highlights, in addition to programmatic updates and discussions about MRCT Center work:
· Keynote address from Peter Arlett, Head of Data Analytics and Methods at the European Medicines Agency (EMA)
· Panel 1: Post-trial Responsibilities: Continued Access to Investigational Products
· Panel 2: International Framework for Specimen Sharing: the Seattle Principles
· Panel 3: Diversity Action Plans and their impact and interpretation through an international and domestic lens
· Research, Development, and Regulatory Roundtable (R3)
· 1) Update on the GDPR, including discussion of the EU/US data privacy framework;
· 2) Considerations for Ensuring Accurate Clinical Trials Data
· Bioethics Collaborative (BC): Gene Therapies: Probing the Ethics
Click here for a detailed agenda, the FAQ, and to register. Open to all registrants at no cost.
left to right: Yasmeen Long (FasterCures), Barbara Bierer (MRCT Center), Esther Krofah (FasterCures), Sally Okun (CTTI) and Carolyn Shore (NASEM)
Diversity Convergence Update
Barbara Bierer, Willyanne DeCormier Plosky, and Hayat Ahmed attended the 2023 Milken Institute Future of Health Summit, where Barbara Bierer spoke as a panelist during the Health Equity Convergence Session. This session was the third meeting of the Diversity Convergence Project, led by Faster Cures, the MRCT Center, CTTI, and NASEM. The discussion focused on community engagement, partnerships, and site enablement (emphasizing the business case for industry involvement), tackling implicit bias, the importance of standardized DEI outcome measures, and rethinking the significance of real-world data and clinical trials. The dialogue extended to exploring avenues for scaling successful programs like NIH’s All of Us, integrating genetic information into clinical trials, and leveraging public-private partnerships for global impact. NASEM will host the fourth meeting for DEI convergence in early Spring 2024.
MRCT Center Faculty Co-Director Mark Barnes honored with PRIM&R Service Award
Public Responsibility in Medicine and Research (PRIM&R) announced Mark Barnes, JD, LLM, as the winner of the 2023 PRIM&R Service Award for being an inspiring and influential leader in the research field.
During his 40-year career, Mr. Barnes has been an unparalleled leader in the areas of research misconduct, human and animal research oversight, health care law, conflict of interest, international research, and data privacy. He is a partner at Ropes &Gray LLP in Boston.
“The PRIM&R Service Award recognizes the many and varied ways that people can have a significant impact on the field. Mark Barnes has tirelessly worked to improve the integrity, safety, and rigor of global clinical trials while being dedicated to mentoring those around him,” said PRIM&R Executive Director Ivy R. Tillman, EdD, CCRC, CIP
Click here to read more.
Events & Presentations
November 30: Dr. Bierer will participate on the panel, “Post-Approval Dissemination of Clinical Study Enrollment Demographic Data to the Public” at the same virtual FDA/CTTI Public Workshop to Enhance Clinical Study Diversity meeting.
December 4 – 6: The MRCT Center at the PRIM&R Annual Conference:
December 4:
· Dr. Bierer: “What Keeps You Up at Night: Future Frontiers in Research”; “IRB Review of Technology Used for Virtual and Virtual/Remote Clinical Trials”
· Sylvia Baedorf Kassis: “Supporting Informed Decision Making: How to Foster the Development of Understandable Research-Related Information”
· Elisa Koppelman: “Including Young People in Research: A Toolkit to Support the Intentional Inclusion of Youth Perspectives in Pediatric Clinical Trials & Product Development”
December 5:
· Dr. DeCormier Plosky: “It’s About Time: Inclusion of Sexual and Gender Minorities in Clinical Research”; “Accessibility by Design: Operationalizing Full Commitment to the Americans with Disabilities Act in Clinical Research Practice”
December 6:
· Dr. Bierer: “Utilizing a System of IRB Precedent: Moving Toward Consistency and Transparency”
· Mark Barnes: “Navigating Data and Specimen Sharing for Transnational Research”; “Building Bridges: Towards an International Framework for Specimen Sharing”
December 13 – 14: The MRCT Center Annual Meeting, including meetings of the Research, Development, and Regulatory Roundtable (R3) and Bioethics Collaborative (BC). Open to all registrants at no cost. (See Spotlight above; click here for more information and to register.)
Publications
November 10: The MRCT Center commented on the Census Bureau’s proposed American Community Survey Sexual Orientation and Gender Identity Test (the ‘Test’) as part of its ongoing American Community Survey Methods Panel Tests. The MRCT Center thanked the Bureau for its commitment to bringing Sexual Orientation and Gender Identity (SOGI) data collection to the foreground. In our response, we asked specific questions about the design of the ‘Test’ and the reliability and privacy of proxy reporting by one household member about the sexual orientation and gender identity of other household members.
November 11: The MRCT Center submitted a response to the Notice for Proposed Rulemaking (NPRM) request of the Office for Civil Rights (OCR) for comments on the draft, “Discrimination on the Basis of Disability in Health and Human Service Programs or Activities.” The MRCT Center applauds OCR’s considerations of the rights of people with disabilities and OCR’s effort to clarify and strengthen Section 504 of the Rehabilitation Act of 1973. The MRCT Center endorsed several key areas in the proposed rule Center presented some suggestions for further clarification.
The MRCT Center provides a unique and trusting community to improve the integrity, safety, and rigor of global clinical trials. Join us in our efforts to develop innovative solutions and aligned approaches to global clinical research.
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