Christian Capitini, Director of UW Carbone Cancer Center, shared on LinkedIn:
“FDA finalizes guidance to broaden clinical trial eligibility.
We should widen inclusion/exclusion criteria as much as feasible.
Clinical trials are the best way we can learn about the safety and efficacy of experimental drugs or regimens, and also get patients access to novel agents”
More thoroughly about the new guidance
- The FDA has finalized three guidance documents aimed at broadening eligibility criteria for cancer clinical trials, addressing performance status, washout periods and concomitant medications, and laboratory values.
- Performance status criteria: Sponsors are encouraged to reconsider rigid requirements that may exclude patients with poorer functional status, particularly when those limitations could improve with treatment.
- Washout periods and concomitant medications: Trial protocols should use scientifically justified washout periods and avoid unnecessarily excluding patients who need medications for other conditions.
- Laboratory value requirements: Eligibility thresholds should be tailored to the investigational treatment and study population, rather than relying on overly restrictive conventional cutoffs. Overall, the recommendations aim to improve trial access, enrollment, and the representativeness of results while maintaining patient safety.
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