In the Spotlight
Announcing the 2023 MRCT Center Annual Meeting: December 13 – 14
Join us December 13 – 14 in Boston for our 2023 Annual Meeting! The MRCT Center welcomes you to engage in dynamic and stimulating discussions and presentations of our programmatic work. This year, we are enhancing the meeting to a two-day program featuring a keynote address from Peter Arlett, Head of Data Analytics and Methods at the European Medicines Agency (EMA), several panel discussions related to our ongoing work, and Research, Development, & Regulatory Roundtable (R3) and Bioethics Collaborative (BC) forums, all open to registrants at no cost.
Click here for more information and to register. While in-person attendance is encouraged, virtual participation is welcome.
Amplifying Participant Voices: Crafting Respectful, Inclusive, and Understandable Patient Materials
As we celebrate Health Literacy Month, we invite you to join us on October 23 from 12-1 PM ET to explore actionable strategies to incorporate participant perspectives to craft patient-facing materials that are accessible, culturally competent, and easy to understand — the key tenets of health literacy. This approach enhances engagement, empowers patients, improves communication, and addresses knowledge gaps, paving the way for improved health outcomes and enriched participant experiences.
Click here to register.
IRB Review of Decentralized Clinical Trials (DCTs): Expert Perspectives
Join MRCT Faculty Director Barbara Bierer, Medable’s Leanne Madre, and Advarra’s Luke Gelinas on October 24 from 1 – 2 PM ET for a webinar addressing the ethical, regulatory, and legal challenges that hinder the wider adoption of decentralized clinical trials (DCTs). During this session, participants will explore the distinctions between DCTs and traditional trials, learn effective strategies to enhance participant engagement with DCT tools and methodologies, and gain insights into the ethical review of DCTs. This work reflects the ongoing collaboration between the MRCT Center and Medable, who released the guidance entitled IRB/EC Considerations for DCT Review in June.
Click here to register.
(left to right): Willyanne Decormier Plosky, Barbara Bierer, Kristin Bartlett, Samjhana Boghati and Hayat Ahmed
Diversity Convergence
The MRCT Center recently hosted an invitation-only Diversity Convergence Project meeting in Washington, DC. The Diversity Convergence Project, a collaborative effort of the Clinical Trials Transformation Initiative (CTTI), FasterCures, the 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. This endeavor prioritizes areas that necessitate collective action to transform clinical trials and focuses on eight key domains (see image).
The dynamic day-long symposium featured robust conversations to define action steps for each of the eight domains to support a collaborative suite of deliverables in 2024. FasterCures will host the third meeting of an expanded group in November 2023 to continue to progress the initiative.
Returning Individual Research Results & Data: Digging Deeper webinar series
The MRCT Center released a series of case studies describing stakeholder experiences of returning individual results to participants. The case studies were discussed at a webinar in May. Given the interest and number of questions we received, we offered three virtual “Digging Deeper” sessions to foster additional discussion about topics that can be challenging to navigate.
The series explored Pfizer’s Participant Data Return Solution, a discussion by Yale leadership on IRB/HRPP Responsibilities, and a dialogue with NCI on Genetic Testing and Secondary Findings. Click here for resources from these webinars, including the recordings, slides, and related materials.
A Global Plain-Language Standard: MRCT Center Glossary Public Review
The MRCT Center continues to lead the co-creation of a plain-language clinical glossary. As a new CDISC global standard, the MRCT Center Clinical Research Glossary is being developed by a workgroup of dedicated volunteers, including patients, advocates, research professionals, medical writers, and others, to deliver understandable and valuable research information to a broad audience. As part of the process, a CDISC public review period is currently open for seven new words and definitions.
Here is the link to the public review package. We have included a helpful video to guide you through submitting a review.
Please click here for more information about the MRCT Center glossary and our collaboration with CDISC to create a plain-language global standard.
Building Resources to Support the Inclusion of LGBTQIA+ Participants in Clinical Research
The Human Rights Campaign has declared a state of emergency for LGBTQ+ Americans and has reported that “more than 75 anti-LGBTQ+ bills have been signed into law this year alone, more than doubling last year’s number.”
To support the focus on LGBTQIA+ inclusion, the MRCT Center has been conducting listening sessions to learn more from diverse clinical research stakeholders about potential areas for action to support greater inclusion of sexual and gender-diverse (SGD) people in clinical research. While the existing portfolio of MRCT Center DEI resources (e.g., Achieving Diversity, Inclusion, and Equity in Clinical Research Guidance Document, IRB/HRPP DEI Toolkit, Inclusion of People with Disabilities in Clinical Research) has been widely used to reduce common barriers to trial participation, we are continuing to develop tailored resources where there are population-specific barriers to clinical research participation.
Respondents in the LGBTQIA+ listening sessions focused on welcoming spaces, imagery, language, data collection (when and how), privacy and safety, site feasibility, and the challenges of multi-site and decentralized trials conducted in disparate environments. We are working on drafting tools to aid sponsors, sites, researchers, and IRBs/HRPPs in fostering greater inclusion and safety of the LGBTQIA+ community in clinical research.
If you would like to share relevant resources or insights, please contact us here.
Events & Presentations
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). Held in Brasilia, Brazil, the meeting will address strengthening clinical trials to provide high-quality evidence on health interventions and 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.
October 23, 12 – 1 PM ET: Amplifying Participant Voices: Crafting Respectful, Inclusive, and Understandable Patient Materials (see Spotlight above). Click here to register.
October 24, 1 – 2 PM ET: IRB Review of Decentralized Clinical Trials (DCTs): Expert Perspectives (see Spotlight above). Click here to register.
November 13, 1:30 – 4 PM: Meeting of the Research, Development, and Regulatory Roundtable (R3). Topic: Recent Regulatory Developments Affecting Clinical Trials in the EU and UK: EU In Vitro Diagnostics Medical Devices Regulation, EU Clinical Trials Regulation, and EMA Policy 0070. Open to R3 Sponsors.
Publications
August 30: MRCT Center Senior Advisor Luke Gelinas co-authored an article with Barbara Bierer and others, “Acknowledging Complexity and Reimagining IRBs: A Reply to Discussions of the Protection-Inclusion Dilemma” in the American Journal of Bioethics. The article responds to the commentary of a prior publication to recognize the nuanced responses to vulnerabilities that too often limit the enrollment of underserved and underrepresented populations.
September 5: The MRCT Center submitted comments in response to the FDA/ICH E6(R3) Guideline for Good Clinical Practice; International Council for Harmonisation; Draft Guideline for Industry (FDA-2023-D-1955-0002). The MRCT Center applauds the overall structural redesign of the E6(R3) GCP guideline and enthusiastically supports the proposed changes. Our comments identified specific areas that we believe, with revision and improvement, will further protect the rights, safety, and well-being of all trial participants.
September 5: Mark Barnes, co-faculty director of the MRCT Center and Partner at Ropes & Gray, colleagues Minal Caron and Sarah Dohan at Ropes & Gray, and Barbara Bierer addressed the definition of “recklessness” in research misconduct proceedings, reviewing its history and application and proposing a framework and factors to consider in recklessness determinations. The work was published in Accountability in Research, available here.
MRCT Center Updates
Daniel Albert-Rozenberg joined the MRCT Center as a Legal Research Assistant in the fall of 2023, focusing on the legal treatment of clinical trial compensation in state and federal benefits calculations. Daniel is currently pursuing his Juris Doctor degree at Harvard Law School.
Jack Ferdman, JD, MPH, joined the MRCT Center in September 2023 as a Research Analyst, focusing primarily on building a framework(s) for clinical research in times of emergency. Jack will also engage in global clinical trial policy analysis and commentary.
Jack brings 15 years of experience in drug and vaccine discovery research to complement his health policy background. Previously, he worked for AbbVie, Seqirus, and Massachusetts General Hospital, among others, and has contributed to health equity efforts with the White House Office of National Drug Control Policy.
New Sponsorship
The MRCT Center welcomes ICON as a new Executive Committee sponsor. ICON is a clinical research organization with a mission to help clients accelerate the development of drugs and devices that save lives and improve quality of life.
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.