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# Characterizing MRD Data in Cancer Trials
- URL: https://www.fdaweb.com/characterizing-mrd-data-in-cancer-trials/
- Published: 2023-03-14T12:00:00.000Z
- Updated: 2026-09-14T18:19:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153973

Staff from CDER and the Oncology Center of Excellence say there are challenges and specific areas for improvement, including assay validation, standardization of collection methods to optimize performance, and considerations in trial design and statistical methodology, in using minimal residual disease (MRD) data as a prognostic biomarker, a measure of clinical efficacy, and a guide for treatment decisions in various hematologic malignancies. Writing in *Clinical Cancer Research*, the FDAers say that over a quarter of new drug and biologic licensing applications involving hematologic malignancies, including 57 registration trials, submitted to FDA between 2004 and 2021 contained MRD data.

“While there have been some successes,” the authors write, “our analysis showed that a substantial proportion of the MRD data that was collected was not sufficiently robust to support inclusion in product labeling. The decrease in acceptance over time is unexpected considering the initial publication of the draft FDA guidance on the use of MRD data in development of drug and biologic products for treatment of hematologic malignancies in 2018 and the interest among stakeholders in advancing the use of MRD in clinical trials.”

The article says MRD has “limitless potential” as a clinical tool and has the potential to expedite drug development. “When used as a surrogate or intermediate clinical endpoint,” it says, “it may allow for an earlier clinical trial readout. This may be especially useful in disease areas where randomized trials with overall survival or progression-free survival endpoints are less feasible…. Moving forward, improvements in assay validation, rigorous collection of MRD data, and appropriate statistical planning are needed to enable greater reliance on MRD data in registrational clinical trials.”