Focus Area: Clinical Trials & Research

Public Comments

Comments provided on: July 22, 2024

Comments provided to: National Institutes of Health (NIH) Office of Science Policy (OSP)

Description: The MRCT Center recommended that NIH OSP (1) clarify and expand on the methods to promote equitable access, (2) consider greater flexibility in the application of this policy to investigational products, and (3) require direct engagement with community stakeholders and patient advocacy groups when NIH assesses the impact of the policy. 

Public Comments

Comments provided on: July 15, 2024

Comments provided to: Office of Science and Technology Policy

The MRCT Center submitted public comments on the White House Office of Science and Technology Policy (OSTP) Request for Information entitled, “Federal Evidence Agenda on Disability Equity,” published at 89 Fed. Reg. 46924 (May 30, 2024). The collection of reliable disability data remains a challenge to researchers, and we applaud the OSTP’s commitment to measurements of health equity that is inclusive of people with disabilities. We share OSTP’s vision for bringing disability data to the foreground and your enthusiasm for understanding where and how best to include questions on disability. In our comments, we focused on information that would be helpful for the understanding of healthcare, health disparities, and clinical research and refrained from commenting on specific survey methodology used in federal and international data collection that is beyond our area of expertise. The MRCT Center pointed the OSTP to standard practices standard practices to safeguard privacy and security, as outlined by federal policy (HIPAA, OHRP, FDA, DOD, NIH, and others) that include a management plan for secure storage and transfer of data throughout the life cycle of the project; communicating clearly with participants when, why, and how disability data will be collected and used; always providing an option for participants to opt-out of answering any or all disability data questions; and only making disability data available [to research teams] through a controlled access environment. We advocate for plain language, logical reading order, the ability to easily go back and correct answers, and the provision of reasonable accommodations during the informed consent process and in any survey/measurement instrument (whether in print, on a computer, or mobile device). Finally, we note that for any form of disability data collection, people with disabilities must first be asked to participate, and that barriers such as inappropriately restrictive screening criteria should be eliminated.

Public Comment

Submitted on: June 25, 2024

Submitted to: U.S. Food and Drug Administration; FDA-2024-D-1377

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 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.

The main takeaway from the public comments that we submitted on the second guidance in the series (ii) “Cancer Clinical Trial Eligibility Criteria: Performance Status” is that we took a strong stance against using Performance Status as an eligibility criterion at all. The measures of performance status commonly used across cancer trial eligibility criteria, the Karnofsky Performance Status Score  (first developed in 1948) and ECOG Performance Status Scale (first developed in 1960), are outdated and highly subjective constructs. Their use as a proxy for disease progression in cancer trial eligibility criteria conflates illness with disability, and results in the discriminatory exclusion of many people with disabilities, which is counter to Section 504 of the Rehabilitation Act, Titles II or III of the Americans with Disabilities Act, and Section 1557 of the Affordable Care Act. We encourage FDA to adopt alternative measures that more appropriately reflect both the clinical risks (assessed by laboratory and diagnostic testing) and the individual participant’s experience and preferences.

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.