In a commentary published in Trials, “Advocating for collaboration among key partners to promote diversity in clinical studies amid policy challenges in the United States of America”, Barbara Bierer and colleagues underscore the urgent need for sustained, cross-sector collaboration to protect and advance diversity in U.S. clinical research. Given the importance of representativeness of the participant population, the authors highlight practical, unified strategies—emerging from the 2023 Stanford Think Tank—to ensure inclusive participation across the clinical research enterprise.
Please join us on Tuesday, June 24, from 3:00-4:00 pm ET for a webinar to launch the MRCT Center and WCG’s Review Framework for Protocols Involving Artificial Intelligence (AI). This framework supports Institutional Review Boards (IRBs) in reviewing research where AI is part of the intervention. The framework was developed through a multi-disciplinary task force, and these actionable tools offer both (1) structured guidance grounded in U.S. regulations and (2) ethical considerations to assist IRBs in evaluating benefits and risks while ensuring oversight and transparency across the AI development lifecycle. This session introduces a practical decision-making resource intended to help IRBs determine when and how to apply appropriate and proportionate oversight to protocols involving AI.
Key Topics:
Introduction to the IRB review framework focusing on aligning review practices with existing regulations and ethical standards.
Structured questions IRBs can use to assess risk, benefits, and ethical considerations when AI is used as a research intervention.
An expert panel discussion on navigating ethical considerations and the question of “AI Exceptionalism” during IRB review.
The MRCT Center hosted a 2-day hybrid meeting in Washington DC in October 2024 to examine the potential benefits, challenges, and opportunities of platform trials for pediatric populations. In addition to consideration of overarching issues, three diseases – pediatric oncology, major depressive disorder (MDD), and multidrug-resistant tuberculosis (MDR-TB) – were chosen to represent different conditions, epidemiology, settings, therapeutic challenges, and patient populations, and to illuminate different potential approaches and solutions.
With ~80 pediatric and platform trial experts from Europe, the UK, Asia, Australia and the US in attendance, the discussants were successfully identified knowledge gaps and practical challenges that impact pediatric platform trial planning and execution. Each of the three subgroups recommended actionable approaches to address identified issues, and the respective groups continued to meet and take concrete steps, furthering the momentum created at the workshop, with the MRCT Center remaining actively involvedwith each disease-specific subgroup to facilitate the next steps.
We appreciate the financial support of several companies, without whom this workshop would not have been possible. The workshop was supported in part by voluntary contributions from AstraZeneca, Johnson & Johnson, and Sanofi. Our thanks to all the individuals who contribute their time and expertise to the planning and conduct of this workshop and without whom this event would not have been possible. We are delighted to share the comprehensive workshop report, a detailed summary of the meeting proceedings.
Podcast Episode: Advancing Pediatric Platform Trials – A Conversation with Dr. Danny Benjamin
Recorded during the MRCT Center’s October 2024 conference, Advancing Pediatric Platform Trials: Streamlining Development, Maximizing Impact, this keynote conversation features Dr. Danny Benjamin, Kiser-Arena Distinguished Professor of Pediatrics at Duke University Medical Center.
Discussion Highlights:
The historical evolution of pediatric drug development and key regulatory milestones
The role and achievements of the Pediatric Trials Network (PTN)
How platform trials can increase efficiency and reduce burden in pediatric research
Ethical and operational challenges unique to pediatric platform trials
Real-world examples demonstrating the value of shared trial infrastructure
Future directions to drive innovation, collaboration, and regulatory alignment
Dr. Lembit Rago, Secretary-General of the Council for International Organizations of Medical Sciences (CIOMS), delivered a compelling keynote on CIOMS initiatives to define and synthesize professional competencies essential for clinical research and emphasized the importance of cooperative agreements to harmonize workforce development efforts.
The session also highlighted the Joint Task Force for Clinical Trial Competency (JTF) Framework as a foundational tool for training and professional development, addressing the challenges and opportunities in recruiting and retaining a diverse and capable workforce.
Sally Armstrong, CEO of PRAXIS Australia, shared how PRAXIS has incorporated the JTF Framework into their educational offerings—including courses, workshops, and immersive onsite training programs.
Susan Landis, Executive Director of the Association of Clinical Research Professionals (ACRP), discussed ACRP’s “Partners Advancing the Clinical Research Workforce” initiative, which uses the JTF Framework to support a diverse and qualified clinical research workforce through training programs, resources, and strategic collaborations.
A recording of the webinar and the presentation slides are available here:
A key aspect of health literacy—especially in clinical research—is understanding what data is collected, how it is protected, and how it is used during and after a study. Truly informed consent requires transparency about data practices so that participants can make educated decisions.
During this webinar we discuss the importance of data literacy, explore practical applications for research teams, and unveil new materials designed to support participants and the broader research community.
Key Topics:
Advancing Data Literacy as a Component of Health Literacy: Explore how understanding research data supports informed decision-making and aligns with broader health literacy efforts.
Applying Plain Language and Visual Tools to Data Communication: Learn how the MRCT Center and PHUSE have used plain language and infographics to make clinical research data more accessible.
Empowering Participants with Transparent and Actionable Information: Identify ways to integrate data literacy resources into your clinical research processes to support research trust and engagement.
Disabled people are often excluded from health research despite being the largest underserved group in many countries, having worked to enshrine legal mandates for fair treatment and equal opportunity, and driving innovations that benefit everyone. The article describes the research cycle, points at which disabled people currently face barriers, and actions that can be taken by the research community to better involve disabled people during those points in the research cycle. This call to action is made by authors from different countries around the world as part of the Disability Inclusion in Research Collaboration (DIRECT) to emphasize the critical importance of collaboration, learning, and support across countries on this issue.
While clinical trials contribute only a small percentage of greenhouse gas (GHG) emissions within the healthcare sector (estimated to contribute 8-12% of overall healthcare related GHG emissions), each stakeholder is responsible for understanding one’s contributions, and all must play their part in mitigation efforts.
The MRCT Center is exploring the complex set of issues related to environmental sustainability in clinical trials.
A series of in-depth discussions with multiple parties identified critical areas and potential approaches, such as the development of standardized carbon footprint analyses for clinical trialsand the assessment of current emission reporting standards.
Building on these insights, we advocated for multi-stakeholder investment in environmentally sustainable practices across the clinical trial lifecycle, including practical and actionable steps each stakeholder in the clinical trial enterprise can take and makes the case for stakeholder consideration of action in the collective effort to achieve net zero emissions while maintaining the value and integrity of clinical trials. A key priority is ensuring that only informative and necessary trials that generate meaningful and actionable data are conducted. Additionally, we recognize that opportunities for improvement exist at every stage of the clinical research lifecycle.
Increase awareness of environmental sustainability in clinical trials through engagement with stakeholders, supporting existing initiatives, and positioning the MRCT Center as a collaborator and possible convener.
Amplify existing efforts to garner buy-in from all involved stakeholders.
Elucidate mitigation opportunities while addressing the complexities and trade-offs accompanying decision-making for clinical trials.
KeY MILESTONES
July 22, 2024: Lisa Koppelman (virtually) presented MRCT Center findings to date at a meeting of The Greener Trials Consortium (UK)
March 2024: Completed a thematic analysis of scoping calls
February 2024: Completed a series of 6 group scoping calls with 4-6 participants each and several additional individual scoping calls, representing the UK, Europe, the US, and South Africa; Stakeholders included academic researchers; clinical trialists; industry
project Leadership & sTAFF
Lisa Koppelman, MSW, LICSW, MPH, Program Director, MRCT Center
A common misconception is that easy-to-understand, plain language information is only necessary in limited situations. However, adopting health literacy best practices benefits everyone who encounters simplified, thoughtfully designed scientific information even in highly technical areas like the data sciences.
In this webinar on Thursday, May 8, from 10 – 11 AM ET, leaders from the Society for Clinical Data Management (SCDM) and the Clinical Data Interchange Standards Consortium (CDISC) will join the MRCT Center to explain why plain language information is essential in the data sciences and how the organizations have embraced a culture of health literacy. This approach benefits both industry members, as well as patients, participants, and their caregivers.
Join us to learn how integrating health literacy and plain language resources improve communication and understanding in clinical research.
Key Topics/Objectives:
By the end of the webinar, attendees should be able to:
Understand the connection between health literacy and data sciences, and why this is a priority for many organizations.
Explain how health literacy and plain language resources have been integrated into organizational initiatives.
Identify opportunities to implement health literacy best practices within their own organizations.
We appreciate your interest and look forward to an engaging discussion.
The MRCT Center, on behalf of the Convergence Project hosted a virtual event focused on workforce development strategies to support a more dynamic and competitive clinical research workforce. This meeting brought together community leaders, policymakers, and researchers to discuss how to create and support pathways into the clinical trial workforce (e.g., part-time degree programs, community colleges, fellowships). Key topics included workforce development, targeted recruitment, and actionable steps to drive systemic improvements, and meeting attendees had the opportunity to pose questions to panelists leading programs in Georgia, North Carolina, South Dakota, and other states across the country.
