Resource Type: Publication

Publication

Published on: February 12, 2025

Published in: Blood Advances

In a Blood Advances article titled “The roadmap to integrate diversity, equity, and inclusion in hematology clinical trials: an American Society of Hematology initiative,” Barbara E. Bierer and co-authors outline a comprehensive strategy to address barriers to diversity, equity, and inclusion (DEI) in clinical research for classical hematologic diseases. These trials face unique challenges, including small sample sizes, methodological limitations, and underrepresentation of diverse populations. Through surveys and five international focus groups with patients, advocates, academia, regulators, industry, and research organizations, the team identified eight priority areas: (1) harmonizing demographic terminology, (2) engaging lived experience experts, (3) mitigating implicit bias, (4) strengthening the role of ethics committees and institutional review boards in upholding justice, (5) broadening eligibility criteria, (6) leveraging decentralized trial designs, (7) improving access to trial information, and (8) increasing engagement of community physicians. Implementing solutions in these areas will foster accessible, inclusive trials and generate representative data to improve research quality, regulatory decision-making, and patient care.

Alice Kuaban, Alysha K. Croker, Jeffrey Keefer, Leonard A. Valentino, Barbara E. Bierer, Stephen Boateng, Donna DiMichele, Patrick Fogarty, C. Michael Gibson, Anna M. Hood, Lloryn Hubbard, Antonella Isgrò, Karin Knobe, Leslie Lake, Iman Martin, Michel Reid, Jonathan C. Roberts, Wendy Tomlinson, Lanre Tunji-Ajayi, Harriette G.C. Van Spall, Caroline Voltz-Girolt, Allison P. Wheeler, Alan E. Mast, Stephanie Seremetis; The roadmap to integrate diversity, equity, and inclusion in hematology clinical trials: an American Society of Hematology initiative. Blood Adv 2025; 9 (4): 687–695. doi: https://doi.org/10.1182/bloodadvances.2024013945

Publication

Published on: August 6, 2025

Published in: Accountability in Research

In an Accountability in Research article titled “Disparate data retention standards in biomedical research”, Barbara Bierer and Carolyn Lye, Minal Caron, Lauren Walsh, and Mark Barnes discuss disparate data retention standards for biomedical research. The article summarizes the divergent data retention standards set forth by federal agencies, grant programs, and research institutions, as well as other applicable requirements under law, contract, and policy.  The authors also discuss the importance of data retention in the context of research professionalism, data sharing efforts, intellectual property issues, and research integrity challenges, and provide recommendations for both institutions and applicable federal agencies to streamline and clarify data retention standards.

Lye, C. T., Caron, M. M., Walsh, L., Bierer, B. E., & Barnes, M. (2025). Disparate data retention standards in biomedical research. Accountability in Research, 1–28. https://doi.org/10.1080/08989621.2025.2543884

Publication

Published on: May 8, 2025

Published in: The American Journal of Bioethics

In the article “Benefits that Offset Research Risks and Burdens are Qualitatively Different,” published in The American Journal of Bioethics, Barbara Bierer joins co-authors Luke Gelinas and Benjamin C. Silverman to examine how indirect benefits offered to research participants (e.g., payments, access to medicines) differ fundamentally from direct benefits that justify risk. The authors argue that these categories of benefit must be conceptually and ethically distinguished in research design and review. Their commentary challenges current interpretations of benefit-risk assessment and calls for greater nuance in ethical review frameworks. 

Gelinas, L., Silverman, B. C., & Bierer, B. E. (2025). Benefits that Offset Research Risks and Burdens are Qualitatively Different. The American Journal of Bioethics, 25(5), 78–80. https://doi.org/10.1080/15265161.2025.2488293

Publication

Published on: May 23, 2025

Published in: Journal of Law, Medicine & Ethics

In the Journal of Law, Medicine and Ethics, Barbara Bierer and co-authors Daniel Albert-Rozenberg, David Peloquin, Joseph Liss, and Erika Hanson published “Assessing Federal Policies to Reduce Economic Barriers to Clinical Trial Enrollment.” The article examines how the risk of losing access to means-tested programs—such as Medicaid, Supplemental Security Income (SSI), Supplemental Nutrition Assistance Program (SNAP), and Temporary Assistance for Needy Families (TANF)—can deter low-income Americans from participating in clinical trials. This barrier disproportionately impacts racial and ethnic minority groups, people with disabilities, elderly individuals, and rural populations, hindering efforts to achieve representative enrollment. The authors recommend that Congress exclude clinical trial payments from gross income and expand the participant compensation exclusions for means-tested programs established under the Ensuring Access to Clinical Trials Act of 2015.

Albert-Rozenberg D, Peloquin D, Liss J, Hanson E, Bierer BE. Assessing Federal Policies to Reduce Economic Barriers to Clinical Trial Enrollment. Journal of Law, Medicine & Ethics. Published online 2025:1-10. doi:10.1017/jme.2025.61

Publication

Presented on: May 15, 2025

Published in: Molecular Therapy

Carolyn Chapman co‑authored a commentary in Molecular Therapy, “Patient‑centered long‑term follow‑up for gene therapies aligns with ethics and science.”

The authors press for follow‑up models that reduce patient and caregiver burden, improve retention, and leverage decentralized methods and real‑world evidence. Achieving this vision will require sustained collaboration across disciplines and meaningful engagement with patient communities.

The article can be accessed and downloaded for free until July 4, 2025, with this link: https://authors.elsevier.com/c/1l5j85QliS8~Iv.

Chapman et al., Patient-centered long-term follow-up for gene therapies aligns with ethics and science, Molecular Therapy
(2025), https://doi.org/10.1016/j.ymthe.2025.04.040