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.
Accessibility by Design (AbD) Toolkit and Resources
The Accessibility by Design (AbD) in Clinical Research Toolkit is now available here. The AbD toolkit was developed with people with disabilities, caregivers, allies, disability rights advocates, and stakeholders in clinical research.
On May 4th, the MRCT Center held a webinar in which Dr. Willyanne DeCormier Plosky presented the background, structure, and key themes of the AbD Toolkit. Invited speaker Cecile González-Cerimele shared lessons learned as a family caregiver during clinical trials, a leader in the planning and conducting of clinical research, and a member of the EnAble employee resource group at Eli Lilly. Duke Morrow could not attend but shared, via moderator Dr. Barbara Bierer, his lived experience as a person with a disability, trial participant, and [community] IRB member. “Any researcher must put aside any knowledge they have learned academically and accept the lived experience of the participants.”
The MRCT Center welcomes your feedback on the AbD Toolkit. Please send suggestions, additional tools and resources, and concerns to mrct@bwh.harvard.edu. We look forward to continuing to work together with people with disabilities, their allies, study teams, sites, and sponsors to further the inclusion of people with disabilities in clinical research.
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.
Click here to view a full webinar recording, download slides, and access the MRCT Center’s Return of Individual Results resources on our dedicated website.
Additional Translations of the Joint Task Force (JTF) Core Competencies
We are delighted to announce that the Joint Task Force for Clinical Trial Competency (JTF) Core Competency Framework for Clinical Research Professionals is now available in Italian and Vietnamese.
Other available translations: English, Spanish, French, Japanese, Thai, and Bahasa Indonesia.
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.
Publications
April 25: Dr. Deborah Zarin co-authored a research letter examining the proportion and timing of results dissemination for registered trials by data source, “Comparison of Availability of Trial Results in ClinicalTrials.gov and PubMed by Data Source and Funder Type,” in JAMA.
April 26: Dr. Barbara Bierer and Sylvia Baedorf Kassis, along with colleagues in the Republic of Korea, China, and the US, co-authored a paper, “Conducting a three-country clinical trial during the COVID-19 pandemic: experience and future considerations,” in International Journal of Clinical Trials, describing the experience of conducting a multinational acupuncture study during the pandemic.
May 8: Dr. Barbara Bierer, Francis Shen, and others published a novel framework specific to the ethical, legal, and social implications of returning individual research results in digital phenotyping research, with specific reference to psychiatry. See “Returning Individual Research Results from Digital Phenotyping in Psychiatry” in the American Journal of Bioethics.
May 25: Dr. Willyanne DeCormier Plosky and Barbara Bierer published “New Tools to Support Inclusion of People with Disabilities in Clinical Research,” based on the recently released Accessibility by Design (AbD) Toolkit, in Amp&rsand, the PRIM&R blog.