Public Comment
Submitted on: April 29, 2024
Submitted to: U.S. Food and Drug Administration
Language: English
Comments Submitted: Draft Guidance, Key Information and Facilitating Understanding in Informed Consent; FDA-2022-D-2997
Public Comment
Submitted on: April 30, 2024
Submitted to: U.S. Food and Drug Administration; HFA-305
Toward a National Action Plan for Achieving Diversity in Clinical Trials
Framework
Presented on: May 6, 2024
Racial and ethnic minorities comprise a significant portion of the U.S. population, yet their representation in clinical trials remains disproportionately low. Addressing this disparity is crucial for equitable healthcare outcomes. Despite recent legislative efforts to improve diversity in clinical trials, and many individual organizational efforts, a national plan to include diverse patients does not exist.
The Clinical Trials Transformation Initiative (CTTI), Milken Institute’s FasterCures, and the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center), and the National Academies Forum on Drug Discovery, Development, and Translation coordinated a series of three convenings (June, September, and November 2023) to inform the publication of a National Action Plan to increase diversity in clinical trials. This national action, which includes eight domains and action steps intended to drive system-wide collective action, is now available here.
Please note, the 4th [hybrid] meeting in this series, entitled “Toward a Framework to Improve Diversity and Inclusion in Clinical Trials,” will be hosted by NASEM in Washington DC on May 20. You can find out more information and register here. This workshop will build on the National Action Plan. We will be focusing on commitment to strategies for equitable participation and innovative trial design to support community investment, engagement, and workforce development.
Related Resources
- Data visualization explorer: A tool for participant representation
- Equity by Design (EbD) in Clinical Research Metrics Framework
- Equity by Design in Clinical Research: A Six-Part Course
- MRCT Center Comment Diversity Plans to Improve Enrollment of Participants From Underrepresented Populations
- MRCT Center Leaning-In Webinar Series
- Achieving Diversity, Inclusion, and Equity in Clinical Research Guidance Document
- Achieving Diversity, Inclusion, and Equity in Clinical Research Toolkit and User Guide
Public Comments submitted: Use of Data Monitoring Committees in Clinical Trials
Public Comments
Comments provided on: April 15, 2024
Comments provided to: U.S. Food and Drug Administration
The MRCT Center submitted public comments to the FDA on its draft guidance on the use of data monitoring committees in clinical trials (Docket #FDA-2001-D-0219). In broad strokes, our comments recommended expanded guidance on the role Data Monitoring Committees can play in actively fostering the safety of trial participants – whether by communicating directly with trial sponsors, IRBs, or with offices within FDA. We also offered critical feedback on specific sections of the draft guidance that seemed incomplete or appeared to contradict other guidance from the FDA. As with all our interactions with the FDA, we commend their commitment to setting the global pace when it comes to ensuring the conduct of scientifically sound, risk appropriate, ethical clinical research.
Public Comments submitted: VolREthics initiative – Global Ethics Charter for the Protection of Healthy Volunteers in Clinical Trials
Public Comments
Comments provided on: March 30, 2024
Comments provided to: VolREthics initiative
The MRCT Center submitted a response to a draft ethics charter intended to protect healthy volunteers in clinical trials published by the French National Institute of Health and Medical Research (“INSERM”). The draft ethics charter consisted of 17 proposed articles; the MRCT Center offered general commentary on the entire charter and provided feedback and/or recommended new language on 14 of the 17 articles. Broadly, the MRCT Center wholly supports the development of an ethical charter to protect healthy trial participants. Our comments reflected our support for the broader endeavor while remaining dedicated to helping INSERM craft language that reflects their well-intentioned goal.
LGBTQIA+ Inclusion – Inclusive Language Checklist
Tool
Published: April 11, 2024
Abstract: In the checklist below, the MRCT Center provides recommendations for the use of language that is respectful to and inclusive of LGBTQIA+ populations. The checklist can be used by stakeholders across the clinical research spectrum, from sponsors to patient navigators, when creating participant-facing documents (e.g., recruitment materials, informed consent forms), drafting study protocol eligibility criteria, and speaking with participants face-to-face. It is our shared responsibility to listen to participants’ and communities’ choice of wording and address, continually learn from each other, and ensure that all eligible people are encouraged to participate by the language that we use.
Related Resources
LGBTQIA+ Inclusion by Design in Clinical Research Toolkit
LGBTQIA+: Inclusive Imagery Case Study
LGBTQIA+: Inclusive Language Checklist
SOGI Data Collection Checklist
SOGI: Data Privacy Checklist
Site Feasibility Decision Tree from the LGBTQIA+ Perspective
Participant Questionnaire from the LGBTQIA+ Perspective
Exit Survey Inclusive of the LGBTQIA+ Perspective
MRCT Center Comment on the American Community Survey SOGI Test
LGBTQIA+ Inclusion – Inclusive Imagery
Case Study
Published: April 11, 2024
Abstract: Each of us feels more welcome to participate in a clinical trial if we see ourselves represented in the visual information communicated about the study, study site/s, and study staff. In the case study below, we illustrate how the MRCT Center worked to build LGBTQIA+ representation into the imagery that was developed for a specific product, the Clinical Research Glossary. The tool shares lessons learned by the MRCT Center based on insights and comments shared by the LGBTQIA+ Inclusion by Design in Clinical Research working group and mock-ups of two of the resulting images.
Related Resources
LGBTQIA+ Inclusion by Design in Clinical Research Toolkit
LGBTQIA+: Inclusive Imagery Case Study
LGBTQIA+: Inclusive Language Checklist
SOGI Data Collection Checklist
SOGI: Data Privacy Checklist
Site Feasibility Decision Tree from the LGBTQIA+ Perspective
Participant Questionnaire from the LGBTQIA+ Perspective
Exit Survey Inclusive of the LGBTQIA+ Perspective
The Clinical Research Glossary: New Words, New Opportunities
Webinar
Presented on: April 2, 2024
With over 160 definitions, including images and supportive information, the Clinical Research Glossary has been designed to support the communication of clear research information, along with tailored, shareable images to foster engagement and understanding.
Learn more about:
- Building trust and transparency with participants through plain language information sharing.
- The dedicated team members, and robust process that is followed, to create this global standard.
- Strategies and approaches to implement the Clinical Research Glossary content into patient-facing materials.
Related Resources
- Common Questions and Answers about the Clinical Research Glossary
- Workgroup Members and Contributors
- How to credit the MRCT Center when using Glossary terms or images
- Webinar Q&A
- Contact Us form to engage with the glossary team
- Return of Results
- Health Literacy in Clinical Research
- Health Literacy training
- COVID flyers
- Baedorf Kassis, S., Facile, R., To, K., White, S., Bierer, B.E. (2023). Use Plain Language to Increase Understanding: The MRCT Center Clinical Research Glossary. DIA Global Forum.
- A Patient Advocate’s story of participating in the Clinical Research Glossary workgroup: Roberta Albany
- Glossary webinar panelist bio book
Master Protocols for Drug and Biological Product Development
Public Comments
Comments submitted on: March 20, 2024
Comments submitted to: U.S. Food and Drug Administration
Ethical Considerations in Decentralized Clinical Trials
Publication
Published on: March 1, 2024
Published in: Journal of Bioethical Inquiry
Description: Barbara Bierer and Sarah White summarized salient ethical issues in the design and conduct of decentralized clinical trials, including participant safety, privacy and confidentiality, consent, digital access and proficiency, and trial oversight. Given the increasing involvement of decentralized study components, it is necessary to develop processes and cooperative solutions to promote safe, ethical trials, as well as focus on decreasing burden and increasing access for all participants.
