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# Stakeholder Comments on Oncology Trial Guidance
- URL: https://www.fdaweb.com/stakeholder-comments-on-oncology-trial-guidance/
- Published: 2024-11-19T12:00:00.000Z
- Updated: 2026-09-14T14:47:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158217

Friends of Cancer Research says an FDA draft guidance on considerations for generating clinical evidence from oncology multiregional clinical development programs is “valuable for addressing key challenges in oncology clinical trials and global drug development programs. We appreciate FDA’s focus on population representativeness, patient diversity, and region-specific analysis.” The comment [letter](ttps://www.regulations.gov/comment/FDA-2024-D-3163-0008) offers these areas for consideration:

- defining representativeness in trials for rare cancers;
- feasibility of multiregional representation in early-phase studies;
- emphasis on data integrity and trustworthiness;
- regional allocation strategy and flexibility;
- coordination with recent diversity guidance documents; and
- feasibility and efficiency in early consultation with FDA.

Pharmaceutical Research and Manufacturers of America (PhRMA) [says](ttps://www.regulations.gov/comment/FDA-2024-D-3163-0009) it supports FDA efforts to issue guidance to build upon existing International Council for Harmonization guidelines on the planning and design of multiregional clinical trials and the acceptability of foreign clinical data, as different, potentially conflicting regulatory requirements can impact sponsors’ ability to conduct clinical trials globally. PhRMA says some language in the draft suggests that FDA may be shifting its approach to evaluating whether data from non-U.S. trial sites apply to the intended use population in the U.S. and to U.S. standard oncological care.

“PhRMA is concerned that this language is seemingly in tension with current regulations regarding the acceptance of foreign clinical data as the sole basis for marketing approval in the U.S.,” it says.

The trade group says there are areas in the guidance that could benefit from revisions and asks for additional FDA flexibility in aspects of U.S. patient enrollment and in situations in which recruitment of U.S. participants is less feasible.

In its [response](ttps://www.regulations.gov/comment/FDA-2024-D-3163-0007), the Association of Clinical Research Organizations says it agrees with FDA that reflecting the intended populations within the clinical trial population is key. “However,” it continues, “there are multiple factors which result in the need for a highly complex set of decisions regarding region and site selection for inclusion in clinical trials.” Such factors, it says, could include statistical considerations for oncology studies, simultaneous global regulatory submissions, biomarker status, and availability of investigators and patients for new studies.