Focus Area: Clinical Trials & Research

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 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.  

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

Related Resources

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

Related Resources

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

Wanted, but Elusive: Clear Solutions for Addressing Potential Group Harm in Data-Centric Research

Publication

Published on: March 11, 2025

Published in: The American Journal of Bioethics

Abstract: Carolyn Chapman and co-authors’ Target Article, “Consideration and Disclosure of Group Risks in Genomics and Other Data-Centric Research: Does the Common Rule Need Revision?” was published in The American Journal of Bioethics: Volume 25 Issue 2, in January 2025. The print publication of this article, which was initially published online in November 2023, was accompanied by 15 Open Peer Commentaries and one Editorial. In March, AJOB published an open-access reply to the commentaries titled “Wanted, but Elusive: Clear Solutions for Addressing Potential Group Harm in Data-Centric Research.”  In the reply, Dr. Chapman and colleagues noted that their main goal with the Target Article was to generate discussion about what, if anything, should be done to ethically manage the potential for group harm in data-centric research; they thanked the commentators for their engagement with the issue. “Wanted, but Elusive” reviews key points in the articles, highlights common themes, and weighs recommendations and next steps.

Data Literacy: Enhancing Trust and Transparency

Webinar

April 3, 2025 @ 10:00 am – 11:00 am

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. Join us for this webinar as 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:

  1. 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.
  2. 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.
  3. 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.

Therapeutic Misconception Revisited 

June 4, 2025 @ 1:00 pm – 3:30 pm

Location: Hybrid

Topic: Therapeutic Misconception Revisited

Abstract: The lines between research and care continue to blur. Pragmatic research studies comparing accepted therapies are increasingly embedded seamlessly into clinical practice. More and more, participation in research deemed promising is offered to patients before standard therapies are exhausted, sometimes as a first-line option. While the concept of “therapeutic misconception”—in very broad strokes, the tendency for individuals to misapply attributes of clinical care to research—has been a mainstay of research ethics for over 40 years, these developments provide an occasion, and perhaps even an urgent need, to revisit it and related topics. How exactly should we understand the therapeutic misconception and what it involves, particularly in cases where the line between research and care really is vague and hard to determine? Even more basically, how should we understand the relationship between research and care in the first place? Are concerns over therapeutic misconception still important, or do they perhaps reflect naïve understandings of research and care and the relation between them–particularly in cases where current options are limited? 

This meeting is open to sponsors of the Bioethics Collaborative. For more information about the Bioethics Collaborative and how to become a sponsor, click here.