In the Spotlight
Upcoming Webinar: June 20th from 10 – 11 AM ET
Ethical Review of Decentralized Clinical Trials (DCTs): Tools, Resources and Best Practices
The MRCT Center and Medable convened a multi-stakeholder task force to address ethical and regulatory opportunities and challenges related to Decentralized Clinical Trials (DCTs). We invite you to join us on June 20, from 10 – 11 AM ET, for a joint webinar entitled, “Ethical Review of Decentralized Clinical Trials (DCTs): Tools, Resources & Best Practices.”
During the webinar, Barbara Bierer (MRCT Center), Pam Tenaerts (Medable) and Leanne Madre (Medable) will present a framework, recommendations, and tools organized around 3 DCT domains: People, Remote Data Collection, and Data Oversight. Best practices for the ethical review, approval, and conduct of DCTs will be provided.
We invite clinical trial stakeholders (IRB/ECs, HRPP, sites, sponsors, investigators, and others) to register for the webinar. Please click here to register.
Dr. Bierer at the African Vaccine Regulatory Forum (AVAREF)
Dr. Barbara Bierer attended the semi-annual African Vaccine Regulatory Forum (AVAREF) meeting in Yaoundé, Cameroon, in April. She presented on the MRCT Center’s efforts to build the capacity of, and to develop tools, training, and resources for, ethics committees across Africa. In addition, with AVAREF leadership, she reported on her visits to Kenya and Nigeria to optimize the conduct and timing of interventional clinical trials.
Return of Individual Research Results and Data: Case Study Resources
On May 2, the MRCT Center hosted the webinar “Returning Individual Research Results and Data to Participants: Experience from the Field.” Over 200 people joined live to hear five leaders from across the clinical trials ecosystem share their experiences supporting participants and designing and implementing institutional procedures to receive individual research results and data.
Thank you to our panelists and attendees for such an engaging session. Click here for a summary of the webinar Q&A with responses to questions we didn’t have time to address live.
Additional Translations of the Joint Task Force (JTF) Core Competencies
The MRCT Center at AAHRPP
Dr. Barbara Bierer and Linda Coleman, JD, Director of the Human Research Protection Program at Yale University, delivered a joint session on the Ethical Review of Decentralized Clinical Trials (DCTs) at the 2023 AAHRPP conference. Challenges in the IRB review of DCTs, as well as institutional HRPP concerns, recommendations, tools, and resources, were discussed at the session.
Sylvia Baedorf Kassis, Program Director at the MRCT, and Jonathan Miller, Associate Vice President for Research Regulatory Oversight at the University of Alabama at Birmingham, discussed the roles and responsibilities of HRPPs in returning aggregate and individual research results, emphasizing the need for a comprehensive, operational plan for returning results return program throughout the study lifecycle. Key resources were also reviewed to support researcher-participant engagement.
Hayat Ahmed, Program Manager at the MRCT Center, showcased tools and resources for incorporating diversity, equity, and inclusion (DEI) in IRB/HRPP processes. The 15 tools developed by the MRCT Center in collaboration with task force members were presented. Conference participants awarded Ms. Ahmed the distinguished poster award.
Events & Presentations
May 10: Dr. Barbara Bierer presented “Diversity, equity, inclusion, and Integrity in clinical trials: towards effective advocacy and action” at the SWOG Cancer Research Network annual meeting.
June 1 from 1:00 – 3:30 PM ET: Research, Development, and Regulatory Roundtable (R3) – open to Sponsors of R3.
Topics: (1) The Revolution in Online Behavioral Advertising – What it Means for the Research Enterprise, (2) Challenges in Decentralized Clinical Trials – Open Discussion Forum
June 20 from 10 – 11 AM ET: Ethical Review of Decentralized Clinical Trials (DCTs): Tools, Resources and Best Practices (see Spotlight above)
Click here to register.