Resource Type: Public Comments

Public Comments

Comments provided on: June 24, 2024

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.

Public Comments

Comments provided on: June 24, 2024

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We responded to a series of three FDA draft guidance documents addressing eligibility criteria for U.S.-based cancer clinical trials.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.

Public Comments

Comments provided on: June 20, 2024

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.

Public Comments

Comments provided on: June 18, 2024

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.

Public Comments

Comments provided on: April 30, 2024

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

Public Comments

Comments provided on: April 29, 2024

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

Public Comment

Submitted on: April 30, 2024

Submitted to: U.S. Food and Drug Administration; HFA-305

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.