Harpreet Singh of the FDA discusses how clinical trial populations are not always reflective of the population of patients who eventually end up getting treated by the therapies.

Clinical trials typically enroll patients who are under 65 years of age, though many patients with cancer are older. The FDA formed a group to look into the reasons for this discrepancy and found that strict eligibility criteria, for example, not allowing anyone with organ dysfunction to enroll, is a frequent reason that older patients are deemed ineligible for a trial.

Singh asks if these criteria are always necessary, especially when testing immunotherapies, which tend to have fewer toxicities and side effects.

Harpreet Singh

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Harpreet Singh on Clinical Trial Eligibility in the Elderly Cancer Population