In April, the FDA published three new draft guidelines for cancer clinical trial eligibility criteria that aim to improve the representation of participants.
The guidelines build on the 2020 guidance and propose that eligibility criteria should be determined and justified based on scientific data; be specific to the trial, the indication and the investigational therapy; and be revisited throughout the clinical development program as data accumulates.
Here are eight FDA recommendations to know:
- Include patients with low-performance status in trials unless scientific rationale exists for exclusion.
- Consider alternative trial designs where concerns exist about including patients with low-performance status.
- Base washout periods on the known pharmacokinetics/pharmacodynamics of previous treatment or parameters related to prior treatment, rather than an arbitrary number of days.
- Exclude concomitant medications only when drug-drug interactions are known or predicted, and will affect patient safety.
- Modify either the dosage of the investigational drug or the concomitant medication to allow continued use during the trial.
- Consider including measures such as patient-reported outcomes of physical function and role function or comprehensive geriatric assessment tools.
- Customize eligibility criteria based on lab values to the specific drug and patient population, and reassess the criteria periodically as more information is gained.
- Consider allowing single repeat lab tests within a certain time frame, as appropriate.