August 2023 Newsletter

In the Spotlight

Returning Individual Research Results and Data: Digging Deeper Webinar Series

Please join us for the final session of our three-part summer webinar series about the specific ethical, operational, and technical challenges to returning individual research results and data on Thursday, September 21, from 12 – 1 PM.

Based on this case study, the webinar will feature a moderated discussion with Megan Frone from the National Cancer Institute about considerations when returning genetic/genomic results.

Click here to register.

Two earlier webinars in this series explored Pfizer’s Patient Data Return Solution and IRB/HRPP responsibilities

Diversity Convergence Project

Racial and ethnic minorities comprise a significant portion of the U.S. population, yet their representation in clinical trials remains disproportionately low. Addressing this disparity is crucial for equitable healthcare outcomes. The Diversity Convergence Project, initiated by the Clinical Trials Transformation Initiative (CTTI), FasterCures, the Multi-Regional Clinical Trials Center of the Brigham and Women’s Hospital and Harvard (MRCT Center), and the National Academies of Sciences Engineering and Medicine (NASEM), seeks to catalyze system-level changes to achieve racial and ethnic diversity in U.S. interventional clinical trials. To fully harness the potential impact and scalability, aligning goals collaboratively with colleagues across the enterprise is essential.
The MRCT will host a meeting on September 22 (invitation only) as part of a series of meetings to drive collaborative actions over the next year. This endeavor prioritizes areas that can truly transform clinical trials, necessitating collective action. The project focuses on eight key domains:

*Public Awareness
*Community Investment
*Community Engagement
*Workforce Diversity
*Site Enablement
*Comprehensive Data Utilization
*Funding, Finances, and Support
*Access and Inclusive Participation

Please stay tuned for forthcoming updates regarding this initiative.

JTF Framework: Chinese Translation

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 Chinese.

Other available translations: English, Spanish, French, Japanese, Thai, Bahasa IndonesiaItalian and Vietnamese

Thank you to the School of Public Health: Capital Medical University, Beijing Tiatan Hospital: Capital Medical University, and Xunyuan for their effort and commitment to creating this translation.

Register for the Joint Task Force for Clinical Trial Competency Biannual Meeting

The next JTF biannual global meeting has been scheduled for November 14, 2023. Please register here to learn about or present updates and coordinate ongoing activities. 

COVID-19 “Should I Join …?” Flyers now in Urdu

The MRCT Center and Harvard Catalyst collaborated in 2020 on a series of clinical research handouts with general information to prepare potential trial participants before recruitment and consent. Several of those brochures have now been translated into Urdu, in addition to English and Spanish.

Thank you to Dr. Farah Asif, Shahtaj Baig, and colleagues at the Shaukat Khanum Memorial Cancer Hospital and Research Centre in Lahore, Pakistan, for their help in adapting and translating the text.

Events & Presentations

September 11, 11 AM – 12:30 PM: Dr. Barbara Bierer will participate in the inaugural Stanford Think Tank on Diversity and Health Equity in Clinical Trials.

September 15, 11 AM – 12:30 PM: Dr. Barbara Bierer will present on a panel entitled, “Use of Regulatory Headwinds to Manage Towards Properly Enrolled Clinical Trials, at the 2023 AAADV (Accelerating Anticancer Agent Development and Validation) Workshop. Learn more about the three-day conference, September 13-15, here.

September 19, 10 AM – 12:30 PM ET: Meeting of the Research, Development, and Regulatory Roundtable (R3) Topic: Research Collaboration with China: Where are we now with Data Privacy, Export Controls, and Foreign Influence? Open to R3 Sponsors.

September 21: 12 – 1:00 PM: Returning Individual Research Results and Data: Digging Deeper Session 3: Genetic Testing (see Spotlight above)

September 22: Diversity Convergence Meeting (see Spotlight above)

September 27: Dr. Bierer will address “Diversity Equity and Inclusion in IRB Review and Oversight” at the HHS OHRP Research Community Forum event co-sponsored with the University of Michigan Human Research Protection Program. The conference, Making a Difference in Human Subjects Research: Empowering Participants, Engaging Communities, and Protecting Data, takes place September 26-27, 2023 as an in-person event. Learn more here.

October 4-5: Dr. Bierer will participate and present at a two-day in-person Regional Workshop, co-sponsored by the Pan American Health Organization/World Health Organization (PAHO/WHO), and the Department of Evidence and Intelligence for Action in Health (EIH). The meeting, to be held in Brasilia, Brazil, will address strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination.

October 10, 1:00 PM – 3:30 PM ET: Meeting of the Bioethics Collaborative (BC). Topic: The Chat is out of the Bag: The future of AI in Clinical Research. Open to BC Sponsors.


July 14: MRCT Center Senior Advisor Luke Gelinas, former MRCT Center Project Manager Walker Morrell, and Faculty Director Dr. Barbara Bierer published an ethical analysis of terms of service and other agreements used in mobile health technologies in clinical research. Risks, mitigating strategies, and recommendations for disclosure (with points to consider) were discussed to help ensure participants’ privacy interests and rights. The article “Terms and Conditions Apply: An Ethical Analysis of Mobile Health User Agreements in Research” was published in the Journal of Law and Biosciences.

July 29: Colleagues in the UK, led by Annabelle South and assisted by Dr. Barbara Bierer, assessed site staff experience in returning plain language summaries to participants after trial completion. Not only did the staff feel that the communication was important, but there were no concerns or challenges in responding to participant questions. Operations and cost were both feasible. The resulting article, “Site staff perspectives on communicating trial results to participants: Cost and feasibility results from the Show RESPECT cluster randomized, factorial, mixed-methods trial,” was published in Clinical Trials.

July 31: The MRCT Center offered comprehensive comments in response to the FDA Draft Guidance FDA-2022-D-2870, entitled Decentralized Clinical Trials for Drugs, Biological Products, and Devices: Draft Guidance for Industry, Investigators, and Other Stakeholders (FDA-2022-D-2870). The MRCT Center applauds the FDA for providing this timely and informative guidance, and our comments are intended to clarify further and expand the Agency’s recommendations. 
August 9: As an outgrowth of an international workshop held in Dec 2022, Dr. Bierer collaborated with experts in multiple sclerosis to develop recommendations regarding diversity and inclusivity of participants in clinical trials investigating multiple sclerosis. Their recommendations, “Enhancing diversity of clinical trial populations in multiple sclerosis,” were published in the Multiple Sclerosis Journal.  
August 11: Former MRCT Center Project Manager Laura Meloney, MRCT Center Project Manager Hayat Ahmed, and Dr. Barbara Bierer coordinated a modified Delphi process to establish consensus on recommendations for IRBs/ethics committees and institutions to promote diversity and inclusion in interventional clinical research. In this paper, they discuss the 25 consolidated recommendations across four themes. The article, “Review of diversity, equity, and inclusion by ethics committees: a Delphi consensus statement,” was published in Med (CellPress).
August 29: Dr. Barbara Bierer co-authored a commentary, “The Unresolved Challenge of Triage,” exploring the ethical and legal challenges of allocating limited care resources in a disaster setting in JAMA.

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.

Learn more about becoming an MRCT Center sponsor.