Draft Guidance: Study of Sex Differences in the Clinical Evaluations of Medical Products; Guidance for Industry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Description: The MRCT Center commented on the FDA’s draft guidance, Study of Sex Differences in the Clinical Evaluations of Medical Products, advocating for the use of real-world data (RWD) and real-world evidence (RWE) to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.

Draft Guidance: Considerations for Including Biopsies in Clinical Trials

Public Comment

Comments provided on: February 24, 2025

Comments provided to: U.S. Food and Drug Administration; FDA-2024-D-2402

Description: The MRCT Center’s public comments on the FDA’s draft guidance, Considerations for Including Tissue Biopsies in Clinical Trials, recommend enhanced clarification on biopsy justification, prioritization of less invasive methods, consent specificity for future research, and strengthened IRB considerations to improve ethical rigor and participant protections.

Comments Submitted: Expedited Program for Serious Conditions – Accelerated Approval of Drugs and Biologics

Public Comment

Submitted on: February 4, 2025

Submitted to: Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration

The MRCT Center submitted public comments in response to FDA’s draft guidance on the accelerated approval program, suggesting areas needing further clarification such as the identification and validation of surrogate endpoints, the rigor and timeliness of confirmatory trials, expansion of public disclosures for regulatory actions, increased transparency regarding decision-making and withdrawal, and global considerations in the absence of international harmonization of these regulations. 

Public Comments submitted: “Ethical Guidelines for Research Using Pervasive Data”

Public Comments

Comments provided on: January 15, 2025

Comments provided to: Chief Counsel, National Telecommunications and Information Administration

Description: The NTIA’s proposed rule on the “Ethical Guidelines for Research Using Pervasive Data” aims to increase U.S. privacy protections with a heightened focus on responsible use. In response, the MRCT Center has submitted a public comment that recommends enhancing safeguards through expanded legislative protections, increased transparency, continuous ethical oversight, and periodic review of data practices to address data advancements and mitigate risks to individuals and communities. 

Public Comments submitted: “Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice”

Public Comments

Comments provided on: December 13, 2024

Comments provided to: U.S. Food and Drug Administration

Description: The FDA draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice,” (FDA-2024-D-2052) highlights the need for maintaining scientific rigor and data reliability when using real world data (RWD) amidst diverse healthcare settings. The MRCT Center comments addressed data quality when using clinical (and variable) data, ethical and practical challenges of randomization in clinical settings, vulnerabilities in data privacy and security, and participant safety while promoting innovative approaches and pilot programs to refine implementation strategies for this purpose. 

Public Comments submitted: “Proposed Rule: Provisions Pertaining to Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons”

Public Comments

Comments provided on: November 29, 2024

Comments provided to: U.S. Department of Justice

Description: The DOJ Notice of Proposed Rulemaking (NPRM), “Provisions Pertaining to Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons,” (DOJ-NSD-2024-0004) aims to safeguard sensitive U.S. personal- and government-related data from countries of concern or covered persons, emphasizing national security and data protection. MRCT Center comments highlighted the need to balance these security measures with global health priorities, recommending explicit public health and research exemptions, alignment with international standards, refined definitions, and transparent compliance to support access to health-related data and the advancement of science, medicine, and individual and public health. 

Public Comments submitted: “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies FDA-2021-D-0789”

Public Comments

Comments provided on: September 25, 2024

Comments provided to: U.S. Food and Drug Administration

Description: The MRCT Center comments point to the need for greater transparency on the timing of FDA feedback and the criteria the FDA is using to assess the community engagement, site selection, recruitment, enrollment, and retentions plans in DAPs (both for domestic and for global trials). We also recommend clarifying whether DAPs are required for Phase 3 trials for both new and previously approved products, how to operationalize a “do no harm” approach in enrollment goals (that may involve global trial participants), and when it may be appropriate to disaggregate US enrollment goals/data from global enrollment goals/data. To improve the final guidance, the comments suggest a framework similar to the April 2022 draft, starting with an epidemiological overview and guiding organizations in developing effective diversity strategies.

Public Comments submitted: “Evolving the Network of the National Library of Medicine NOT-LM-24-001”

Public Comments

Comments provided on: August 30, 2024

Comments provided to: National Institutes of Health

Abstract: The MRCT Center recently submitted comments to the National Library of Medicine (NLM) in response to the “Evolving the Network of the National Library of Medicine” initiative (NOT-LM-24-001), emphasizing the importance of enhancing health literacy through better access to clinical research information. Key recommendations included expanding MedlinePlus to include more content related to clinical trials, integrating plain language definitions into ClinicalTrials.gov, and providing aggregate study results in plain language for participants. The MRCT Center also suggested improvements to ClinicalTrials.gov that would allow current participants to access updates on study progress and individual results and harmonize study-specific data elements to facilitate cross-study comparisons. These recommendations aim to improve public engagement, transparency, and trust in the clinical research ecosystem.

Public Comments submitted: “Strategies for Maximizing Public Engagement in NIH Supported Clinical Research”

Public Comments

Comments provided on: August 9, 2024

Comments provided to: National Institutes of Health

Description: The MRCT Center submitted public comments on the NIH Request for Information regarding Strategies for Maximizing Public Engagement in NIH Supported Clinical Research (NOT-OD-24-133). The MRCT Center recommended that NIH encourage researchers and their institutions to establish continuous and bilateral relationships with the communities where they intend to conduct research prior to, during, and after the research. Researchers should cultivate bi-directional partnerships with the communities, budget for those activities, and provide training. Several of our collaborators with meaningful lived experiences, including study participants, patient advocates, and clinical researchers, contributed to the response.