In the Spotlight
MRCT Center launches Return of Individual Research Results project and website
The MRCT Center Webinar for the Return of Individual Research Results (IRR) Project Launch was held on March 24, 2022. Thank you to our MRCT Center speakers: Dr. Barbara Bierer, Faculty Director, and Lisa Murray, Project Manager. A special thank you to our guest speaker, Jamie Tyrone, Patient Advocate, for sharing her story and highlighting the importance of this initiative. The webinar recording and slides are available on the IRR project website.
Advancing International Pediatric Clinical Research Part Three
The MRCT Center is pleased to announce the third of the 5-part virtual conference series to advance global pediatric clinical trials. Entitled “Assent and consent in the field: culture, context, and respect,” the conference will focus on the cultural context of assent and the challenges and solutions encountered on the ground. A panel of global experts will share their experiences with assent, including how to manage the tension between an (ideal) ethical framework and cultural context.
The two-hour webinar will be hosted twice: Tuesday 28 June 2022 at 9-11 am EDT and Wednesday 29 June 2022 at 8-10 pm EDT with similar content but different speakers and panelists, to allow for wide attendance and global participation.
MRCT Center Pediatric Brochures for Youth
We are delighted to announce the release of 3 new pediatric educational brochures in the series about clinical research topics. Developed by high school and college students, written for 12- to 17-year-olds, reviewed by international youth advisory networks, and proudly bearing the International Children’s Advisory Network (iCAN) Seal of Approval. Translations to other languages and additional brochures are forthcoming.
Equity by Design in Clinical Research: Cancer Trials virtual training series recap
The MRCT Center hosted, in partnership with the Center for Cancer Equity and Engagement, Dana-Farber/Harvard Cancer Center, a six-part training series entitled “Equity by Design in Clinical Research: Cancer Trials.” Each module consisted of a 45-minute video lecture and 45 minutes of an interactive discussion session with experts in the field. Over 450 people were registered. All course registrants have until May 13 to finish viewing recordings and to complete their evaluation forms for credit. After May 13, all course materials will be made publicly available on the MRCT Center website (not for CME credit). More
The MRCT Center concludes AVAREF virtual training course
The MRCT Center – AVAREF virtual training course for Ethics Review of Clinical Research concluded in April 2022. The course included participants from 22 different countries across Africa and was simultaneously translated into French.
Case-based learnings and breakout room discussions were integrated into course lectures to create a stimulating and engaging virtual learning environment. The MRCT Center looks forward to continuing its partnership with AVAREF to build regulatory capacity across Africa.
MRCT Center launches health literacy training for Human Research Protection Programs (HRPPs) and Institutional Review Boards (IRBs)
The MRCT Center has launched an online introductory health literacy training for Human Research Protection Programs (HRPPs) and Institutional Review Boards (IRBs). The course supports IRB members and staff learning about health literacy and their roles in reviewing and approving clear, understandable participant-facing research communications. Via a Facilitator’s Guide, IRBs can engage in group discussion at their institution after completion of the training.
PRESENTATIONS
March 31, 2022: Research! America hosted an Alliance Discussion with MRCT Center Faculty Director, Barbara E. Bierer, about why IRR requires a policy framework that respects patient rights and promotes transparency in a responsible and efficient manner (and what challenges may be ahead). View webinar
April 28, 2022: Dr. Barbara Bierer was a panelist discussing “Diversity, Inclusion, and Equity in Clinical Trials – a moral and ethical imperative” at the Clinical Trials Platform for a Talking Trials Webinar hosted by South Australian Health and Medical Research Institute.
PUBLICATIONS
March 1, 2022: MRCT Center Program Director Deborah A. Zarin, MD, and Harry P. Selker, MD, MSP authored “Reporting of Clinical Trial Results: Aligning Incentives and Requirements to Do the Right Thing” in Clinical Therapeutics. The authors argue that FDAAA and other trial reporting policies should be systematically and comprehensively enforced, in order to ensure that results from all clinical trials become available to inform clinical, policy or research decisions in a timely manner. Read more
March 4, 2022: Joseph Liss, former Legal Fellow at the MRCT Center, David Peloquin, Mark Barnes and Barbara Bierer co-authored “Applying Civil Rights Law to Clinical Research: Title VI’s Equal Access Mandate,” published in The Journal of Law, Medicine & Ethics. Title VI of the Civil Rights Act of 1964 prohibits federally-funded educational institutions and health care centers from engaging in discrimination “on the ground of race, color, or national origin.” The authors argue that the Department of Health and Human Services (HHS) “has not used the full arsenal of legal and policy tools at its disposal to push for equal rights” to obligate institutions that receive federal funding for clinical research “to provide equal access to participation in clinical trials to racial and ethnic minority communities.” Read More
March 7, 2022: MRCT Center colleagues Barbara E. Bierer, Laura G. Meloney, Hayat R. Ahmed, Sarah A. White authored a commentary in Cell Reports Medicine, “Advancing the inclusion of underrepresented women in clinical research.” Read more
March 2022: The Proceedings from the National Academies of Science, Engineering and Medicine (NASEM) workshop “Adoption of Health Literacy Best Practices to Enhance Clinical Research and Community Participation” were released in March. Barbara Bierer, Elizabeth Cahn, and Sylvia Baedorf Kassis, are featured. Read more
April 8, 2022: Deborah Zarin, MRCT Center Program Director, co-authored “Completeness of clinical evidence citation in trial protocols: A cross-sectional analysis,” published in Med, Cell Press. The authors conclude that “clinical trial protocols undercite accessible, relevant trials and do not document systematic searches for relevant clinical trials. Consequently, ethics review committees often receive an incomplete picture of the research landscape if they review protocols similar to those deposited on ClinicalTrials.gov.”
April 2022: Dr. Barbara Bierer is featured in the Exploring Drug Discovery and Development article “Scientists and communicators team up to increase clinical trial participation,” that includes a look at clinicians, researchers, and communicators developing more effective strategies to disseminate information about clinical trials to reach a wider audience. Read more
WELCOME TO THE MRCT CENTER!
Nora Hutchinson, M.D.,C.M., MPhil, joined the MRCT Center in April 2022 as a Postdoctoral Research Fellow. Most recently, she worked under the supervision of Jonathan Kimmelman PhD at McGill University, funded by a Fonds de Recherche Santé Québec postdoctoral research grant. Her research focuses on the ethics, patient involvement, and clinical impact of pharmaceutical drug development.
Molly Siegel joined the MRCT Center as a Student Researcher in the spring of 2022 working on a project related to trial termination. She will continue her involvement with the MRCT Center by providing data collection and analytic support across various ongoing projects at the Center.
A LOOK AHEAD
May 25, 2022: Sarah White will join plenary session 4 entitled “Mandatory vs. Mission Creep? The Role of DEI in IRBs and HRPPs” at the 2022 AAHRPP Annual Conference in Denver, CO.
June 14, 2022: The MRCT Center has organized a panel presentation at the BIO International Convention on June 14, 2022 from 4:15 PM – 5:15 PM PDT at the San Diego Convention Center. The panel presentation is titled “Equity by Design: Utility of a Metrics Framework and Metrics To Evaluate Progress on Diversity, Equity, and Inclusion in Clinical Research.” Speakers will include Willyanne DeCormier Plosky (MRCT Center), Neha Londoño (Seagen), and Inez Ruiz-White (Otsuka).