Resource Type: Public Comments

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Description: The MRCT Center commented on the FDA’s draft guidance, Study of Sex Differences in the Clinical Evaluations of Medical Products, advocating for the use of real-world data (RWD) and real-world evidence (RWE) to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

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The MRCT Center submitted public comments in response to FDA’s draft guidance on the accelerated approval program, suggesting areas needing further clarification such as the identification and validation of surrogate endpoints, the rigor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

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Description: The FDA draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice,” (FDA-2024-D-2052) highlights the need for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

Comments provided on: October 8, 2024

Comments provided to: Congresswoman Robin Kelly

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

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.