Focus Area: Clinical Trials & Research

Global Development of Clinical Research Workforce: Tools and Resources

Webinar

Date: April 3, 2025

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:​

On-demand YouTube webinar recording: Global Development of a Clinical Research Workforce: Tools and Resources
2025-04-03 MRCT Center JTF Global Workforce Development webinar slidesDownload

Related Resources:

Data Literacy in Clinical Research: Enhancing Trust and Transparency

Webinar

Date: April 3, 2025

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.

The MRCT Center and PHUSE are collaborating to develop a suite of resources, including videos and infographics, to enhance data literacy in the clinical research context.

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.
FINAL 25-04-03 MRCT PHUSE Webinar Slides_FINAL_Received-09-APR-2025Download

Related Resources:

MRCT Center Clinical Research Glossary

PHUSE – The Global Healthcare Data Science Community

PHUSE Working Group: Educate the General Public on Data Privacy and Data Sharing

Comment: A global call to action for disability inclusion in health research

Publication

Published on: March 26, 2025

Published in: Nature Medicine

Abstract: Barbara Bierer and Willyanne DeCormier Plosky co-authored an article, led by Anna M. Anderson (University of Leeds), in Nature Medicine titled, “A global call to action for disability inclusion in health research.”

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.

View the article

Environmental Sustainability in Clinical Trials

Environmental Sustainability in Clinical Trials

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 continues to explore the complex set of issues related to environmental
sustainability in clinical trials. In Europe and many other parts of the world, the focus on environmental sustainability is prominent with well-established efforts to study and reduce GHG. The U.S. interest and investment, strong in many individual states and companies, is variable.

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 trials and 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.  

Contact Information: mrct@bwh.harvard.edu

OBJECTIVES

  • 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
  • Trevor Baker, MS, Program Manager, MRCT Center
  • Barbara Bierer, MD, Faculty Director, MRCT Center

Project Resources

A Shared Language for Clinical Research: How Technical Organizations are Embracing Plain Language and Implementing the MRCT Center Clinical Research Glossary 

Webinar

May 8, 2025 @ 10:00 am – 11:00 am

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.

Workforce Development: Opportunities to Engage and Retain Talent in Clinical Research

Webinar

Presented on: February 25, 2025

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.

Webinar Meeting Summary
2025_02_25e_Summary Convergence meetingDownload

Related Resources

Toward a National Action Plan for Achieving Diversity in Clinical Trials


Working with Partner Countries to Strengthen Research Capacity Relating to Global Representation

Guidance

Published on: March 24, 2025

Capacity strengthening is vital to ensure that countries—particularly those with limited resources—can conduct effective, high-quality clinical research. The ability to perform rigorous trials is often constrained by inadequate infrastructure, regulatory processes, and a lack of trained researchers. As noted by the Science for Africa Foundation, despite accounting for over 25% of the global disease burden, Africa hosts only about 4% of global clinical trials. To address these gaps, supporting locally-driven capacity-building initiatives is key. This involves collaborating with national health departments, research institutions, and local communities to create sustainable, long-term systems that enhance both healthcare and research capabilities.

Capacity-building efforts can be approached at three levels: individual, organizational, and national. These include fostering researcher skills, improving research infrastructure, and strengthening the national regulatory environment. It is essential to work with local stakeholders to identify needs and design solutions that will be effective long term. For example, external funders can support training opportunities for local researchers, enhance regional collaboration, and promote community engagement to raise awareness of clinical research. By taking a comprehensive, staged approach to capacity strengthening, we can build resilient research systems that ultimately lead to more inclusive healthcare innovation and a more equitable global research landscape.

2025-3-19-Capacity_StrengtheningDownload

Embedding Ethical Considerations Relating to Global Representation

Guidance

Published on: March 24, 2025

Embedding Ethical Considerations Relating to Global Representation in Clinical Research offers a thorough exploration of the ethical issues surrounding global representation in clinical trials. Central to the document is the ethical imperative to ensure that clinical research reflects the populations most affected by the diseases being studied while addressing the systematic inequalities that limit access to participation. The guide raises key ethical questions: Are the right groups being included in the research? How can we ensure that participants will benefit from the outcomes, both during and after the study? How are diverse populations, particularly in low-resource settings, engaged ethically and without exploitation?

This document also provides a valuable framework for study sponsors and research teams, offering a series of ethical considerations and questions that should be addressed throughout the study process. These considerations include the need for thoughtful engagement with local communities, careful assessment of barriers to participation, and strategies to reduce the risk of exploitation or undue inducement. By documenting their responses to these ethical questions, sponsors and study teams can ensure that their studies are conducted with integrity, fairness, and respect for all participants, helping to create research that is not only scientifically valid but also ethically sound and globally representative.

2025-2-6-_Embedding_Ethical_Considerations CLEANDownload

Innovative Approaches for Gene Therapy Long-Term Follow-Up: Leveraging Registries and Platform Trials

Webinar

May 6, 2025 @ 1:00 pm – 2:00 pm

Please join us on Tuesday, May 6, from 1-2 pm ET for a webinar that will explore different approaches for realizing Gene Therapy (GT) Long-Term Follow-Up (LTFU). GTs have the potential for long-lasting and transformative health benefits, but there are also long-term health risks. Therefore, the FDA recommends long-term safety monitoring of recipients of certain types of GTs. As these LTFU studies can last years (even up to a lifetime), they pose significant scientific and logistical challenges. We are grateful for our three distinguished panelists, who will discuss innovative approaches for GT LTFU. 

Dr. Barbara Konkle, a hematologist at the Washington Center for Bleeding Disorders, Professor of Medicine Emeritus in Hematology-Oncology at the University of Washington, and the Medical Director of the Bleeding Disorders Laboratory at Bloodworks NW, will share information about the goals and development of the World Federation of Hemophilia’s Gene Therapy Registry (GTR). The GTR is a prospective, observational, and longitudinal registry designed to collect long-term data on people with hemophilia who receive GT. 

Dr. Amy Moskop is an Assistant Professor in the Department of Pediatrics and the Division of Hematology/Oncology/BMT at the Medical College of Wisconsin and the Scientific Director of the Gene Therapy Program at the Center for International Blood and Marrow Transplant Research (CIBMTR). Dr. Moskop will provide an overview of the CIBMTR registry and its intersection with GT LTFU. 

Dr. Avery McIntosh, Director, Biostatistics, Internal Medicine and Infectious Disease at Pfizer, will share practical considerations for GT LTFU safety studies and provide an overview of the potential benefits of platform and master protocol approaches. Dr. McIntosh has co-authored a paper on this topic, published in 2024 (doi:10.1002/cpt.3087). He has co-edited a book, Development of Gene Therapies: Strategic, Scientific, Regulatory, and Access Considerations, also published last year.

Dr. Carolyn Riley Chapman, who leads the Cell and Gene Therapies project at the MRCT Center, will moderate.

February 9, 2024

Cell and Gene Therapies ›

Draft Guidance: Study of Sex Differences in the Clinical Evaluations of Medical Products; Guidance for Industry

Public Comment

Comments provided on: March 11, 2025

Comments provided to: U.S. Food and Drug Administration; FDA-2024-D-4245

Description: The MRCT Center commented on the FDA’s draft guidance, Study of Sex Differences in the Clinical Evaluations of Medical Products, advocating for the use of real-world data (RWD) and real-world evidence (RWE) to support post-marketing evaluations of sex differences, inclusion of intersex and transgender individuals, additional guidance on the inclusion of pregnant and lactating individuals, and further advice on statistical approaches to detect sex-based differences.

MRCT Center FDA 2024-D-4245Download