Artificial Intelligence (AI) and Clinical Research
Artificial intelligence (AI) in clinical research is being deployed across all aspects of research, both as an experimental intervention, and as an ancillary tool to support the administration of research and optimize trial design, planning, recruitment, and analysis. The MRCT Center established this project to explore the actionable, practical, and ethical considerations when using artificial intelligence (AI) in clinical research. As with all research involving human participants, effective and efficient use of AI in clinical research should be grounded in existing ethical principles and governing regulations to protect participants.
In 2024, the MRCT Center, in collaboration with WCG Clinical, convened a multidisciplinary task force to develop resources to address ethical and regulatory challenges during the IRB review of clinical research involving AI as the experimental intervention. In 2025, the task force publicly launched the Framework for Review of Clinical Research Involving Artificial Intelligence.
In 2026, the MRCT Center and WCG Clinical task force expanded its membership and focus to developing actionable, practical deliverables for the use of AI in the administration of clinical research.
This new project direction examines the use of AI in areas such as protocol development, trial modeling, site selection, participant recruitment and outreach, data collection and management, statistical analysis, and post-marketing requirements and aims to develop stakeholder responsibilities and guidance on responsible oversight, institutional responsibilities, and best practices for monitoring of AI systems.
In 2025, the MRCT Center also launched a webinar series on the use of digital twins and synthetic data to create virtual simulations of patient outcomes and how these approaches aim to improve the efficiency of clinical trials. The MRCT Center continues to work to evaluate the technical, ethical, and practical considerations involved with the use of digital twins and synthetic data.
OBJECTIVES
Define and analyze the current critical ethical and regulatory challenges of deploying AI across the clinical research lifecycle.
Discuss and develop practical and actionable resources to strengthen the capacity of IRBs, sponsors, and investigators to protect participants in research as AI’s role continues to grow.
Identify new resources and tools needed by stakeholders in the clinical research ecosystem.
KeY MILESTONES
February 2026: Convened the first meeting of the MRCT Center and WCG Clinical task force on the use of AI in the Administration of Research.
November 2025: Held a webinar in the AI Digital Twins and Synthetic Data series on Practical Use Cases in Clinical Research.
October 2025: Organized a panel during the MRCT Center’s Annual Symposium on the opportunities and challenges posed by the integration of AI in the informed consent process.
September 2025: Launched the first webinar in a series on AI Digital Twins and Synthetic Data: Practical Use Cases for Clinical Research
June 2025: Held a webinar to launch the Framework for Review of Clinical Research Involving Artificial Intelligence
November 2024: Organized a panel session during the MRCT Center’s Annual Symposium on Expanding the Uses of Data and AI in Support of Clinical Trials, beginning the Digital Twins and Synthetic Data workstream.
March 2024: Convened the first meeting of subject matter experts, including representation from academic medical centers and universities, industry, AI technologists, and IRB ethicists, members, and chairs.
project Leadership & sTAFF
Barbara Bierer, MD, Faculty Director, MRCT Center
Donna Snyder, MD, MBE, Executive Physician, WCG Clinical
Trevor Baker, MS, Program Manager, MRCT Center
Olchey Tchavyntchak, Research Assistant, MRCT Center
Comments provided to: U.S. Food and Drug Administration
Summary: 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.
Comments provided to: U.S. Food and Drug Administration; FDA-2024-D-1376
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.
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.
Comments provided to: U.S. Food and Drug Administration
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.
Comments provided to: National Institutes of Health, Office of Science Policy
Summary: 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.
You need to be logged in to view this content. Simple Membership is not configured correctly. The login page or the join us page URL is missing in the settings configuration. Please contact Admin
Published in: The Journal of Law, Medicine & Ethics
Summary: COVID-19 illuminated the need for equity-informed practices in public health. This manuscript, to which Sylvia Baedorf Kassis and Dr. Barbara Bierer contributed, presents a community-led Ethics and Equity Framework and Workflow Checklist to guide ethical and equitable engagement with between community health centers and the populations they serve.
The critical role of representation in clinical research, particularly for LGBTQIA+ communities, and an overview of the foundations supporting the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit.
Essential considerations for collecting SOGI data, covering survey and form design, appropriate language in study materials, and the protocols for collecting, storing, and sharing SOGI data.
Practical implementation examples and areas that require further research and guidance.
Federal Committee on Statistical Methodology (FCSM) Sexual Orientation, Gender Identity, and Sex Characteristics Subcommittee: https://www.fcsm.gov/groups/sogisc/
Hafeez H et al. Health Care Disparities Among Lesbian, Gay, Bisexual, and Transgender Youth: A Literature Review. Cureus. 2017;9:e1184. Accessed August 7, 2023. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5478215/
Institute of Medicine (US) Committee on Lesbian, Gay, Bisexual, and Transgender Health Issues and Research Gaps and Opportunities. (2011). The health of lesbian, gay, bisexual, and transgender people. National Academies Press (US). Accessed August 7, 2023. https://www.ncbi.nlm.nih.gov/books/NBK64806/
Landers SJ et al. Sexual Orientation Differences in Asthma Correlates in a Population-Based Sample of Adults. Am J Public Health. 2011:101:2233-2244. Accessed August 7, 2023. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3222437/
Fredriksen-Goldsen KI et al. Health and Access to Care and Coverage for Lesbian, Gay, Bisexual, and Transgender Individuals in the U.S. Am J Public Health. 2017:107:1332-1338. Accessed August 7, 2023. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5508186/
Hughes LD et al. Differences in All-Cause Mortality Among Transgender and Non-Transgender People Enrolled in Private Insurance. Demography. 2022;59:1023-1043. Accessed August 30, 2023. https://doi.org/10.1215/00703370-9942002
Morris M et al. Training to reduce LGBTQ-related bias among medical, nursing, and dental students and providers: a systematic review. BMC Medical Education. 2019;19:325. Accessed August 30, 2023. https://doi.org/10.1186/s12909-019-1727-3
Dahlhamer JM et al. Barriers to Health Care Among Adults Identifying as Sexual Minorities: A US National Study. Am J Public Health. 2016;106:1116. Accessed August 29, 2023. https://doi.org/10.2105/AJPH.2016.303049
Sterling J et al. Cancer screening in the transgender population: a review of current guidelines, best practices, and a proposed care mode. Transl Androl Urol. 2020;9(6):2771-2785. Accessed August 7, 2023. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7807311/
Cahill S et al. Do Ask, Do Tell: High Levels of Acceptability by Patients of Routine Collection of Sexual Orientation and Gender Identity Data in Four Diverse American Community Health Centers. PLoS ONE. 2014;9:e107104. Accessed August 7, 2023. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0107104
Daniel H et al. Lesbian, Gay, Bisexual, and Transgender Health Disparities: Executive Summary of a Policy Position Paper From the American College of Physicians. Ann Intern Med. 2015;163:135-137. Accessed August 7, 2023. https://doi.org/10.7326/M14-2482
Badgett MVL. (2009). Best Practices for Asking Questions about Sexual Orientation on Survey. Los Angeles: The Williams Institute. Accessed August 7, 2023. https://escholarship.org/uc/item/706057d5
Spade D. Normal Life: Administrative Violence, Critical Trans Politics, and the Limits of Law. Durham, NC: Duke University Press; 2015.
Brown I, McKenzie M, Srirangam A, Patel S. Making an Inclusive Impact: LGBTQ+ Health Equity in Clinical Trials. Poster presented at Drug Information Association Global Annual Meeting: June 25-29, 2023; Boston, MA.
Data on File. Genentech, Inc. South San Francisco, CA.
