RECORDINGS AND RESOURCES FROM MRCT CENTER WEBINARS
Equity by Design in Clinical Research: The EbD Metrics Framework
The MRCT Center launched Equity by Design in Clinical Research: The EbD Metrics Framework, a tool that outlines 7 domains of strategic and tactical considerations to advance DEI in clinical research. Intentionally high-level, the framework can be adapted to the work of all organizations. Speakers discussed how their organizations have used the Framework to complement their own work and to stimulate action. Watch the webinar HERE. Access the Framework HERE.
Equity by Design in Clinical Research: A Six-Part Course
This MRCT Center course is now publicly available and provides training to advance diversity, equity, and inclusion (DEI) of underrepresented populations in clinical trials. Ethical and regulatory considerations are included, and practical guidance for commitment, communication, partnership, and conduct is emphasized. This course was originally conducted as a live virtual course (titled Equity by Design in Clinical Research: Cancer Trials). It has been reformatted to be accessible continuously online (not for credit). While some examples in the course are cancer-specific, the course content is broadly applicable to all health areas. Each of the six modules contains a 45-minute recorded instructional session and a 45-minute recorded discussion session with leaders in the field. ENROLL NOW.
Supporting IRB Efforts to Advance Diversity and Inclusion in Clinical Research Tools and Resources
This webinar introduced tools and resources created for IRBs and human participant research programs to help drive DEI in clinical research. Watch the launch webinar HERE. Access resources HERE.
MRCT Center Online Health Literacy Training for IRB Members and Staff
The MRCT Center launched a new online Health Literacy training for IRB members and staff. Designed as a self-paced virtual learning opportunity, IRB members and staff learn to apply health literacy principles to the IRB role. The training includes a facilitation guide to support implementation. Watch the launch webinar HERE. Find the training resources HERE.
Advancing International Pediatric Clinical Research Assent and Consent in the field: Culture Context, and Respect
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,” focused on the cultural context of assent, consent and the challenges and solutions encountered on the ground. Recordings and slides are available HERE
Using Social Media During a Research Study: How to Connect with Others Safely and Successfully
Intended for research participants, Jamie Tyrone, a dedicated patient and advocate, explains the benefits and risks of using social media in research. The video, a product of the MRCT Center Bioethics Collaborative and publication, was developed to help participants use social media knowledgeably. Access video HERE.
JTF Framework Available in French
In collaboration with F-CRIN (French Clinical Research Infrastructure Network) and several other partners, we are pleased to offer the Joint Task Force for Clinical Trial Competency (JTF) Framework in French. This framework defines the knowledge, skills, and attitudes necessary for conducting safe, ethical, and high-quality clinical research and has been used around the world. Access the Framework HERE.
PRESENTATIONS
May 26, 2022: MRCT Center Executive Director, Sarah White, MPH, joined a plenary session 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: MRCT Center Program Manager, Willyanne DeCormier Plosky, Ph.D., participated in two plenary sessions at the BIO 2022 International Convention in San Diego, CA:
“Diversity and Inclusion in Clinical Trials: Concrete Strategies for Enhancing Health Equity” MORE
“Equity by Design: Utility of a Metrics Framework and Metrics To Evaluate Progress on Diversity, Equity, and Inclusion in Clinical Research” MORE
June 28, 2022: MRCT Center Faculty Director, Dr. Barbara E. Bierer, presented “Optimizing Targeted Clinical Trial Recruitment and Increasing Diversity, Equity & Inclusion: Leveraging Data Analytics and Collaboration,” a webinar organized by Ropes & Gray and Mass Insight.
July 14, 2022: Dr. Barbara E. Bierer presented “Equitable Engagement and Practices for Children’s Vision Research” in a session at the “The Forum on Children’s Vision: Vision Health and Quality of Life” at Prevent Blindness Focus on Eye Health National Summit. MORE.
PUBLICATIONS
March 2022: MRCT Center Program Director Deborah A. Zarin, together with Harry P. Selker, 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. MORE
April 2022: MRCT Center Senior Advisors, Luke Gelinas and David Strauss, together with Dr. Barbara E. Bierer, and others authored, “IRBs and the Protection-Inclusion Dilemma: Finding a Balance,” published in The American Journal of Bioethics. The authors address the tension that Institutional Review Boards (IRBs) face “in aiming to both protect potential research participants from harm and include under-represented populations in research” and offer recommendations to support IRB decision-making. MORE
May 2022: Barbara E. Bierer, Sarah White, MRCT Center Senior Administrative and Training Manager, Carmen Aldinger, and MRCT Center consultant Stephen Sonstein co-authored “Self-assessed Competencies of Clinical Research Professional and Recommendations for Further Education and Training,” published in Therapeutic Innovation & Regulatory Science. A global survey of clinical research professionals asked to self-assess their level of competency for each of the 8 domains of the Joint Task Force for Clinical Trial Competency (JTF) Framework, showed that irrespective of role, years of experience, or educational level, lower levels of competency were expressed in the domains of Scientific Concepts and Research Design and Investigational Product Development and Regulation. MORE
May 2022: MRCT Center Project Manager Walker Morrell, Barbara E. Bierer, and colleagues co-authored “When Is a Change Significant? The Update Problem of Apps in Medical and Behavioral Research” in Ethics & Human Research. Digital applications (apps) used in research may be updated while the research is ongoing, potentially necessitating ethics review. The authors argue that the review process should depend on the nature of the change, any potential change in risk or benefit, and consideration of confidentiality and safety. MORE
May 2022: The MRCT Center submitted public comments to the U.S. Food and Drug Administration in regard to “Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials.” MORE
June 2022: Barbara E. Bierer and MRCT Center Program Director Laura G. Meloney co-authored “Strategies to optimize inclusion of women in multi-national clinical trials,” published in Contemporary Clinical Trials. The authors note the persistent complexities in the representation of women in clinical trials, particularly in some therapeutic areas and in certain countries. The article includes approaches and suggestions to address the problem. MORE
June 2022: Deborah A. Zarin co-authored “Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis,” published in BMJ. The authors describe an approach for reporting master protocol research programs that is consistent with existing good reporting practices and that uses structured information to convey the overall master protocol and design of each substudy. MORE
June 2022: MRCT Center Program Director Sylvia Baedorf Kassis, together with Sarah White, Barbara E. Bierer, and others co-authored “Developing and implementing a self-monitoring toolkit for a coordinated multinational randomized acupuncture trial,” published in BMC Complementary Medicine and Therapies, which describes a self-monitoring toolkit that was developed and implemented in a coordinated multinational trial that involved sites in China, South Korea, and the U.S. Authors conclude that such a tool “provides a feasible, consistent, and effective way to review the collection and maintenance of data and regulatory documentation for quality assessment in minimal risk clinical research studies and can augment formal study monitoring activities.” MORE
WELCOME TO THE MRCT CENTER
Four new Project Managers joined the MRCT Center in June 2022:
Sarah Evenson manages the Bioethics Collaborative and the Research, Development, and Regulatory Roundtable (R3) forums, organizing and preparing content for the meetings as well as leading projects on the ideas that arise during discussion. Sarah graduated from Haverford College in 2021 with a BA in Sociology and completed a Master of Bioethics at the University of Pennsylvania Perelman School of Medicine in 2022. She has previously been an intern in the Biomedical Ethics Research Program at Mayo Clinic and served as a research assistant in a neurobiology lab and on a project investigating the ethics of machine learning applications in precision medicine.
Lauren Otterman is primarily involved in the Center’s work on Promoting Global Clinical research in Children and Return of Aggregate Study Results to participants. Lauren has a background in the Boston non-profit sector, where she worked in various programmatic and operational roles at My Life My Choice and Social Venture Partners Boston. Lauren obtained her Master of Bioethics and Health Law degree from the University of Otago in Dunedin, New Zealand. Her dissertation focused on the ethical, legal, and social impacts of emerging reproductive technologies, specifically artificial womb technologies.
Juliette Pluviose-Philip is primarily involved in the Diversity, Inclusion and Equity in Clinical Research project. Prior to joining the MRCT Center team, Juliette worked with the Boston Public Health Commission’s Neighborhood Trauma Network Team on program evaluation projects. Juliette also has experience as a Research Assistant in the Clinical Laboratory of Occupational Therapy and Health Equity at Boston University’s Sargent College, where she worked on decreasing racial maternal mortality disparities, program evaluation, and health literacy. Juliette obtained her Master of Public Health Degree in Community Assessment, Program Design, Intervention, and Evaluation with a concentration in Maternal and Child Health from the Boston University School of Public Health.
Kayleigh To is currently focusing on projects in Health Literacy in Clinical Research and Post-Trial Responsibilities and Continued Access to Investigational Medicines. Prior to joining the MRCT Center, Kayleigh worked as a research assistant at Brigham and Women’s Hospital researching cardiology and preventative medicine in the Division of Preventive Medicine. She also interned at the Usher Syndrome Coalition where she created tools for governmental advocacy and produced accessible materials summarizing Usher syndrome-related news for the community. Kayleigh graduated from Boston University with a Master’s in Public Health concentrating in Health Policy and Law.