June 2024 Newsletter

In the Spotlight

Please join the MRCT Center and the Research Ethics Action Collaborative for HRPPs (REACH) for the first webinar in the Accessibility 101 series. People with disabilities are the largest minority population in the United States, yet they are often excluded from clinical trials, both as participants and as researchers. Federal regulations, such as the recently updated Section 504 of the Rehabilitation Act, prohibit discrimination based on disability. Many accommodations are easy and low or no cost. It is incumbent upon all of us to build accessibility into our everyday thinking, meetings, presentations, and planning. This webinar will help advance that goal.

This webinar will feature two interactive exercises in which participants will learn:

  • Basic information about disability statistics and disability rights, as shown through the Accessibility by Design in Clinical Research Toolkit, and different types of support 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’s (and family caregiver’s or supporter’s) journey from different disability perspectives, from getting to/into the site location, navigating within the site to the different areas they must access, and interacting with different forms of medical equipment and technology.

More Information about REACH:

Research Ethics Action Collaborative for HRPPs (REACH) is an initiative spearheaded by the MRCT Center, AAHRPP, PRIM&R, and Mass General Brigham to curate, align, and disseminate tools to advance access to and

inclusion in research—for all potential participants–tailored for Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), and the broader community.

 Click here to learn more.

New Project Spotlight: Ethical Challenges in AI-Based Clinical Research

Recently, the MRCT Center, in collaboration with WCG Clinical, convened a task force to address ethical and regulatory challenges during the IRB review of clinical research protocols involving AI.

The task force includes diverse stakeholders from across the clinical research ecosystem, including representatives from academic medical centers and universities, biotechnology and pharmaceutical companies, AI technology researchers, and IRB ethicists, members, and chairs. This multidisciplinary group aims to shape guidelines and resources addressing the layered ethical and practical implications of applying AI in and to clinical research.

As AI continues to play an increasingly important role in society and clinical research, the task force will evaluate its use in various aspects of clinical trials, including protocol design, consent considerations, patient privacy and confidentiality, and participant recruitment. It will also evaluate AI when it is being studied as an investigational product for use in medical care. The task force aims to create guidelines and tools to strengthen the capacity of IRBs, ethicists, and investigators to protect participants in research as AI’s role continues to grow.

For more about this project, click here.

NOW OPEN through July 5: Public Review of the Clinical Research Glossary

The MRCT Center’s recently expanded Clinical Research Glossary has been developed with the input of an engaged stakeholder workgroup, including patients and participants, advocates, and clinical research professionals.

New words and definitions in the MRCT Center’s Clinical Research Glossary undergo a Public Review each year. This review allows anyone to provide feedback on existing terms and suggest new ones for consideration. Public Review ensures that the terms and definitions are a CDISC global standard.

We invite you to participate in this important process to refine and enhance this valuable resource, empowering participants with the health literacy tools they need to make informed decisions about their care.

Click here to learn more and contribute your feedback.

For more about the Clinical Research Glossary and how four organizations – Mass General Brigham (MGB) Rally, HonorHealth, the Society for Clinical Data Management (SCDM), and the CureMito Foundation – are implementing it in participant communications, click here.

On-Demand: Data Collection and Privacy: Tools and Resources for LGBTQIA+ Inclusion by Design

At a recent webinar, the MRCT Center released two new tools to the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit: the SOGI Data Collection Checklist and the SOGI Data Privacy Checklist.

Click here to view this on-demand webinar, download the slides, or access the extensive related resources list.

May 29-30: The MRCT Center External Advisory Board (EAB) held its ninth annual meeting on May 29. The EAB provided Center leadership input and perspective on select MRCT Center projects as well as an overarching strategy of the Center. The following day, May 30, the MRCT Center Executive Committee (EC) met to discuss emerging issues, the MRCT Center’s work in Africa, revisions to the Declaration of Helsinki, and upcoming meetings.  

June 4: “Action and Influence – Implementing the Clinical Research Glossary and Your Critical Role in Public Review” webinar. On-demand resources, including the recording and slides, are available here.

June 11: “Data Collection and Privacy: LGBTQIA+ Tools and Resources” webinar. On-demand resources, including the recording and slides, are available here.

July 10-11:  The MRCT Center will host the “Global CIM (Comprehensive and Integrative Medicine) Summit,” a program of the Comprehensive and Integrative Medicine Institute (CIMI) in South Korea. The meeting will feature discussions on planned research and outcomes and an update on the USA-Korea-China clinical research collaboration involving a three-country clinical trial.

July 22 – 26: Invited by and in collaboration with the African Vaccines Regulatory Forum (AVAREF), Barbara Bierer will be a member of a team traveling to Lusaka, Zambia, in late July to assess national regulatory and ethics committee processes. The mission is part of continent-wide capacity building in Africa.

May 31: Sylvia Baedorf Kassis and Barbara Bierer contributed to an article, “A Federally Qualified Health Center-led Ethics and Equity Framework & Workflow Checklist: An Invited Commentary in Response to a Relational Public Health Framing of FQHCs during COVID-19” in the Journal of Law, Medicine & Ethics.

COVID-19 illuminated the need for equity-informed practices in public health. This manuscript presents a community-led Ethics and Equity Framework and Workflow Checklist to guide ethical and equitable engagement between community health centers and the populations they serve.  

June 18: (NOT-OD-24-112). The MRCT Center submitted public comments on a proposed glossary of innovative clinical research terms published jointly by FDA and NIH, “FDA-NIH Terminology for Clinical Research.” We encouraged clarification of the scope and intended audience of the draft glossary and recommended additional terms for inclusion in the final version. The FDA-NIH glossary will complement the MRCT Center’s Clinical Research Glossary efforts.

June 18: Sylvia Baedorf Kassis contributed an article, “An Easy-to-Understand Clinical Research Glossary to Support Participants and Professionals,” to the Association of Clinical Research Professionals (ACRP) Blog.

June 20: Mark Barnes and Barbara Bierer published “Proposed Increases in Government Authority Over Research Misconduct Proceedings” in the American Medical Association’s JAMA Viewpoints.

The article examines a proposed increase in government authority over research misconduct proceedings and notes that academic and medical institutions should understand the public, political, and ethical pressures on the Office of Research Integrity (ORI) to enhance oversight of research integrity. Institutions can alleviate some of these pressures by making their research misconduct processes more exacting, efficient, and, when possible, more transparent regarding the outcomes of specific cases. This can lead to improved public trust in the scientific research enterprise.

June 20:  (FDA–2023–D–5470): FDA continued its guidance series on RWE, issuing “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products.” In support of the guidance, the MRCT Center submitted public comments requesting further development of FDA’s concerns that are unique to RWE-based studies and the cross-referencing of the current guidance to specific sections of other RWE guidance documents to streamline the end-user experience.

June 24: The MRCT Center submitted public comments in response to the World Medical Association’s (WMA’s) second phase of proposed revisions to the Declaration of Helsinki (DoH). Mark Barnes, MRCT Center Faculty Co-Director, attended the last working meeting on the DoH. In direct response to concerns discussed internally and with our Executive and Steering Committees, we recommended substantial revisions to the WMA Workgroup’s proposals, including recommending comments specific to vulnerable populations, research ethics committees, informed consent, and post-trial access. Both Mark Barnes and Barbara Bierer have been invited to attend the final WMA revision discussion meeting in Washington, D.C. this August.

June 24: Sylvia Baedorf Kassis and Barbara E. Bierer were co-authors of a paper published in “Cancer” entitled “Acupuncture for hot flashes in hormone receptor‐positive breast cancer: A pooled analysis of individual patient data from parallel randomized trials.” The MRCT Center helped advise the study teams in the coordination and conduct of multi-national, collaborative research.

June 25: We responded to a series of three FDA draft guidance documents addressing eligibility criteria for U.S.-based cancer clinical trials. For all three documents, we were supportive of the efforts the FDA has taken to make clinical trials more representative of the intended post-approval patient population. We encouraged additional clarity and granularity with regard to operationalizing these draft guidelines, in advance of their final issuance. Further, we agreed that eligibility criteria should be carefully considered, caution against copying and pasting eligibility criteria from the protocol of one study into the draft protocol of a new study, and advocate that exclusion criteria should be clearly justified based on safety or ethical reasons.

(FDA-2024-D-1402) Specific to the first draft guidance of the series, (i) “Cancer Clinical Trial Eligibility Criteria: Laboratory Values,” we stated in our public comment submission that the MRCT Center agrees with the FDA that overly restrictive laboratory value-based eligibility criteria are problematic and that such criteria may well exclude the very cancer patients that may benefit from the treatment under study, particularly when the malignancy (or its prior treatment) is affecting those lab values. The MRCT Center also asked for more specific examples of how to describe the potential variation of lab values (e.g., by race) and any additional/confirmatory testing needed in the eligibility criteria so as to better support a position of inclusion-by-default and exclusion-only-when-necessary.

June 25: (FDA-2024-D-1377). The main takeaway from the public comments that we submitted on the second guidance in the series (ii) “Cancer Clinical Trial Eligibility Criteria: Performance Status is that we took a strong stance against using Performance Status as an eligibility criterion at all. The measures of performance status commonly used across cancer trial eligibility criteria, the Karnofsky Performance Status Score  (first developed in 1948) and ECOG Performance Status Scale (first developed in 1960), are outdated and highly subjective constructs. Their use as a proxy for disease progression in cancer trial eligibility criteria conflates illness with disability, and results in the discriminatory exclusion of many people with disabilities, which is counter to Section 504 of the Rehabilitation Act, Titles II or III of the Americans with Disabilities Act, and Section 1557 of the Affordable Care Act. We encourage FDA to adopt alternative measures that more appropriately reflect both the clinical risks (assessed by laboratory and diagnostic testing) and the individual participant’s experience and preferences.

June 25: (FDA-2024-D-1376). Our public comments on the third guidance (iii) “Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications,” asked the FDA to clarify its use of the term “medication,” whether either the recommendations regarding concomitant medications or the washout period differ in the case of early (Phase 1/2a) versus late (Phase 3 and post-approval) trials, and when additional data and sub-studies might be needed to understand potential drug-drug interactions when participants are taking concomitant medications for chronic conditions.

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.

Learn more about becoming an MRCT Center sponsor.