In the Spotlight
Join Us for the MRCT Center’s Annual Symposium in Boston!
Mark your calendar for mid-November to attend a dynamic three-day symposium featuring presentations and discussions with thought leaders and research stakeholders. The first day is open to Executive and Steering Committee (EC/SC) sponsors. The annual two-day event that follows is open to all registrants at no cost. While we encourage in-person attendance, virtual participation is welcome.
Wednesday, November 13: The day will begin with a meeting with the Post-trial, Continued Access to Investigational Medicines in Lower and Middle-Income Countries working group, followed by lunch and the EC/SC meeting.
Thursday, November 14: The day will kick off with a keynote address (TBA) and continue with presentations on the MRCT Center’s recent and upcoming work, breakout sessions, and a cocktail reception. A more detailed agenda will be released in our September newsletter.
Friday, November 15: Vivli, the Center for Global Clinical Research Data, in conjunction with the MRCT Center, will host “Innovations in Data Sharing,” a half-day program featuring Dr. Steffen Thirstrup from the European Medicines Agency (EMA).
A link to the registration will be emailed separately in the next two weeks.
Global Representation in Clinical Trials: New Resources
We are thrilled to unveil a suite of new resources aimed at advancing representation in global clinical trials:
- Model Diversity Action Plan (DAP): This tool, developed in response to the FDA’s latest draft guidance, is designed to improve diverse participant enrollment in clinical trials. It provides clear objectives and strategies for proactive recruitment, supporting alignment with FDA guidelines. The Model DAP builds upon these guidelines by emphasizing a broader international viewpoint and providing an appendix with detailed implementation suggestions.
- Global Diversity, Equity, and Inclusion (GDEI) Roadmap: This comprehensive guide offers insights into and addresses DEI across trials that involve sites outside of the US. It emphasizes the organizational preparation needed long before writing study diversity action plans, considerations of country regulatory and research priorities, and fair trial participation and access to tested products.
- The first podcast in our new series, “Trials Beyond Borders: Building Representative Clinical Trials Worldwide.” The podcast features a conversation with MRCT Center Program Director Willyanne DeCormier Plosky and Tinaya Gray, a consultant with ICON plc, focusing on communications between sponsors, CROs, and sites in planning for diversity action plans in the context of global trials.
We encourage you to investigate these new tools and listen to our podcast episode. Additional ethics and capacity-building tools, part of our Global Representation toolkit, are forthcoming.
Upcoming Events: Health Literacy Month Webinar Series
To celebrate Health Literacy Month this October, the MRCT Center invites you to participate in three engaging and informative webinars. These sessions will provide practical tools and foster robust discussions, benefiting anyone interested in incorporating health literacy and accessibility best practices into communicating participant-facing clinical research information. We encourage you to join all three sessions! You can register for each webinar below.
Session 1: Designing Impactful Informed Consent Processes that Empower Participants
Thursday, October 10, 12 – 1 PM ET
This webinar will feature the HHS Office of Human Research Protections, the NIH All of Us Research Program, and the MRCT Center, highlighting resources for communicating informed consent information in innovative, participant-centered ways.
Session 2: Creating and Sharing Plain Language Summaries: One Team’s Experience
Thursday, October 17, 12 – 1 PM ET
This MRCT Center webinar will feature experts from the Dana-Farber Cancer Institute who will share their return of results process for developing and making Plain Language Summaries available to participants in breast cancer-related studies driven by patient-advocates.
Session 3: Designing PowerPoint Presentations to Support Health Literacy and Accessibility
Tuesday, October 22, 12 – 1 PM ET
Spearheaded by the MRCT Center, AAHRPP, PRIM&R, and Mass General Brigham, the Research Ethics Action Collaborative for HRPPs (REACH) is an initiative designed to curate, align, and disseminate tools to advance representative inclusion in research—for all potential participants–tailored for Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), and the broader community.
Join the REACH collaborative webinar on improving PowerPoint presentations through clear, accessible, and inclusive methods. We will show, through examples from the Accessibility by Design in Clinical Research Toolkit, how to apply accessibility tools to health literate communications. Because much communication is now virtual, we’ll explore how to make PowerPoint content readable and approachable, formatted for accessibility, and inclusive of people with disabilities.
On-Demand: Accessibility 101: How to Write Alt-Text and Map Participant Journeys
The MRCT Center and the Research Ethics Action Collaborative for HRPPs (REACH) presented the first webinar in the Accessibility 101 series in July, featuring two interactive exercises in which participants learned:
- Basic information about disability statistics and disability rights, as shown through the Accessibility by Design (AbD) in the Clinical Research Toolkit, and different supports that you can readily implement.
- How to find the Check Accessibility and Alt Text features in PowerPoint and write appropriate Alt Text.
- How to map the participant, family caregiver and/or supporter journey from different disability perspectives, from getting to/into the site location, navigating within the site to the other areas, and interacting with varying medical equipment and technology.
The Joint Task Force for Clinical Trial Competency (JTF), anchored at the MRCT Center, is dedicated to developing and disseminating standards and practices for the clinical research workforce. The JTF fosters a cohesive, global approach to ensuring that professionals have the necessary competencies to conduct clinical trials effectively and ethically.
Updates: The meeting summary and slides from the June JTF Biannual Global Meeting Summary, celebrating the 10th anniversary of the publication of the JTF Core Competency Framework, are now available.
The JTF Framework has been translated into Portuguese, and is the twelfth translation now available. See the complete list here.
Contribute to Equitable Access: Share Your Experiences with Out-of-Pocket Costs in Clinical Trials
The MRCT Center is collaborating with the Equitable Access to Clinical Trials (EACT) project, hosted by the LUNGevity Foundation, to share best practices and promote financial neutrality for patients in clinical trials. The EACT project is developing a narrative document to demonstrate how extensively and in what contexts patients face out-of-pocket costs associated with medical care (e.g., labs, diagnostics, visits, medications) in clinical trials. If you have examples from your experience conducting cancer trials or as a cancer research participant, that you could share to inform this document, please go to the top of the EACT homepage and click on “SEEKING YOUR STORIES! TAKE OUR SURVEY.” There is a template for responses and examples. Responses may be submitted anonymously.
Global CIMI Summit
In early July, the MRCT Center hosted the “Global CIM (Comprehensive and Integrative Medicine Summit 2024” at the Harvard Faculty Club in support of the ongoing collaboration with the Comprehensive and Integrative Medicine Institute (CIMI), Daegu Catholic University Medical Center (DCUMC), Dana-Farber Cancer Institute (DFCI) and other collaborators. Ten participants from South Korea–from CIMI, Daegu Catholic University School of Medicine, Daegu Haany University, and Chungang University School of Medicine– joined 14 U.S. collaborators from the MRCT Center, DFCI, Creighton University, Osher Center for Integrative Medicine, and others. This marks the 10-year anniversary of the CIMI/DCUMC collaboration with the MRCT Center. The summit was followed by a day of site visits (at MRCT Center, DFCI, and Osher Center) for the South Korean participants.
(Left to right: David Peloquin, Theresa Walsh, Barbara Bierer, Mark Barnes)
Ropes & Gray Pro Bono Awards
The international law firm Ropes & Gray recently recognized the long-standing public health pro bono work of Mark Barnes. Mark Barnes co-founded the MRCT Center, and in his comments of appreciation, Mark credited several partners, including Barbara Bierer, his partner at Ropes & Gray and MRCT Center Senior Advisor David Peloquin, and his long-term assistant and friend Theresa Walsh.
Events & Presentations
Left to right: Missy Heidelberg (Takeda Pharmaceuticals), Matt Rotelli (Eli Lilly and Co), Anna Kang (Genentech – a member of the Roche Group), Cris Woolston (Sanofi), Pat Nebel Hill (Genentech – a member of the Roche Group), CeCe Brotchie-Fine (Novartis), Karla Childers (Johnson & Johnson), Diana Pankevich (Pfizer), Barbara Bierer (MRCT Center)
August 15-16: Barbara Bierer attended the North American Regional Meeting on the Declaration of Helsinki (DoH) in Washington, DC, a meeting that was also attended by several MRCT Center Executive Committee and Steering Committee representatives. The meeting was the final discussion of the DoH revision. Dr. Bierer discussed the challenges in determining scientific and social value in clinical trials.
August 24: Sylvia Baedorf Kassis was a featured speaker at the iCAN Virtual Chapter Meeting, sharing information on the Clinical Research Glossary and ways for young people to get involved.
August 30: Barbara Bierer presented on single IRB review of multi-site, multinational clinical trials at the international meeting entitled, “the U.S. single IRB policy: challenges and lessons,” hosted by the Pan American Health Organization (PAHO) Regional Program on Bioethics and Quality and Regulation of Medicines and Health Technologies Unit.
Upcoming Webinars and Presentations
September 10: Meeting of the Bioethics Collaborative: Impact of Dobbs on Reproductive Health: Unintended Consequences for/on Research.
September 10: Sylvia Baedorf Kassis will present the Clinical Research Glossary at Pfizer’s internal Health Literacy & Patient Activation Community of Practice meeting.
September 29 – 30: Sylvia Baedorf Kassis will present two panels at the Society for Clinical Data Management (SCDM) conference in Boston.
October 10, 12 – 1 pm ET: Health Literacy Month Webinar Series – Session 1: Designing Impactful Informed Consent Processes that Empower Participants
October 10: Meeting of the Research, Development, and Regulatory Roundtable (R3). Topics: 1) Laboratory Developed Tests, and 2) Limitations on Sharing Data with China and Other Countries of Concern
October 10, 8 am – 4:30 pm ET: Dr. Barbara Bierer and Mark Barnes will be featured as panelists at the “Advancing Trust in Science: Institutional Obligations to Promote Research Integrity,” a hybrid event hosted by the Department of Medical Ethics & Health Policy and the Institute for Translational Medicine & Therapeutics: University of Pennsylvania Perelman School of Medicine.
October 15, 12:00 pm ET: Willyanne DeCormier Plosky will present at the SCRS IncluDE Site Summit follow-up webinar titled “IncluDE Encore: Inclusivity Forum for People with Disabilities.”
October 17, 12 – 1 pm ET: Health Literacy Month Webinar Series – Session 2: Creating and Sharing Plain Language Summaries: One Team’s Experience
October 22, 12 – 1 pm ET: Health Literacy Month Webinar Series – Session 3: Designing PowerPoint Presentations to Support Health Literacy and Accessibility
Nov 13 – 15: MRCT Center Annual Symposium. A registration link will be sent separately soon.
November 15, 9 am – 2 pm ET: Vivli Annual Meeting, in conjunction with the MRCT Center: “Innovations in Data Sharing.” Keynote with Dr. Steffen Thirstrup of the European Medical Association (EMA).
Publications
Stephen Sonstein and Barbara Bierer are co-authors of a Frontiers in Pharmacology editorial that introduces the collection of the Research Topic: “Building the Clinical Research Workforce: Challenges, Capacities and Competencies.” Thirteen articles discuss the challenges and opportunities relating to the clinical research workforce and highlight the role and significance of the Joint Task Force for Clinical Trial Competency (JTF) Framework. Frontiers in Pharmacology has also published “Building the Clinical Research Workforce: Challenges, Capacities and Competencies” as an eBook.
Mariana Kruger, Moji Adeyeye, and Barbara Bierer co-authored a book chapter entitled “Pediatric drug development issues during public health emergencies” in the book Essentials of Translational Pediatric Drug Development. In their chapter, the authors outline the regulatory and ethical issues that arise during public health emergencies, focusing on pediatric drug development.
July 15: The MRCT Center commented on the White House Office of Science and Technology Policy (OSTP) Request for Information entitled “Federal Evidence Agenda on Disability Equity,” published at 89 Fed. Reg. 46924 (May 30, 2024). Read more here
July 22: The MRCT Center commented on the National Institutes of Health (NIH) Office of Science Policy’s draft Intramural Research Program Policy: Promoting Equity Through Access Planning (NOT-OD-24-125). In brief, the MRCT Center recommended that NIH OSP (1) clarify and expand on the methods to promote equitable access, (2) consider greater flexibility in the application of this policy to investigational products, and (3) require direct engagement with community stakeholders and patient advocacy groups when NIH assesses the impact of the policy. Read more here.
August 1: Barbara Bierer authored an article, “The Role of Institutional Review Boards in Improving the Inclusion of Sex and Gender as Variables in Clinical Research,” in the Journal of Bone and Joint Surgery.
August 5: Mark Barnes, colleagues at Ropes & Gray, and Barbara Bierer published “The PubPeer conundrum: Administrative challenges in research misconduct proceedings” in the journal Accountability In Research that analyzed the impact of PubPeer, an online platform that publicizes suspected data integrity concerns, on the research misconduct process and the institutional challenges of handling anonymous comments within current regulations. The authors propose processes to ensure that credible allegations are rigorously assessed while reducing the burden on institutions tasked with their investigation.
August 9: The MRCT Center commented on the NIH Request for Information regarding Strategies for Maximizing Public Engagement in NIH Supported Clinical Research (NOT-OD-24-133). The MRCT Center recommended that NIH encourage researchers and their institutions to establish continuous and bilateral relationships with their communities prior to, during, and after research, budget for those activities, and provide training. Several of our collaborators with meaningful lived experiences, including study participants, patient advocates, and clinical researchers, contributed to the response. Read more here.
August 19: The MRCT Center commented on the NIH Request for Information regarding its draft Public Access Policy (FR Doc. 2024-13373). We recommended that NIH require plain language summaries for all manuscripts submitted to PubMed Central. We supported NIH’s proposal to eliminate the embargo period for publications while requesting further consideration of the practical implementations of the proposed change, sensitive to the potential increase in costs to manuscript submission and other unintended consequences. Read more here.
MRCT Center Updates
Kaitlin Hersey joined the MRCT Center as a Project Coordinator in August 2024. With over a decade of diverse experience in biotech startup environments, nonprofit organizations, and executive support, Kaitlin brings her robust organization, document control, and operations experience to the Center’s administrative team. In her role, Kaitlin will leverage her understanding and passion for innovative, accessible healthcare to drive the center’s administrative and operational aspects forward.
Kaitlin holds an Associate of Science from Massachusetts Bay Community College and a Phi Theta Kappa Honor Society membership.
Mena Shaikh joined the MRCT Center as a Research Trainee/Student Intern in the summer of 2024. She works principally with Carolyn Chapman on the Cell and Gene Therapies project. She is interested in exploring the intersection of public health and clinical medicine and the epidemiology of noncommunicable diseases.
Mena received her BS in Biochemistry from Stony Brook University in 2021. She is currently pursuing her MPH in Epidemiology and Biostatistics from Boston University.
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.
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