USA – FDA suggests letting more patients with viral infections into cancer clinical trials

A draft guidance, not yet implemented, suggests allowing more patients with hepatitis B and C and HIV into oncology clinical trials from which they are currently excluded.

On the pages of oncology clinical trials on the database ClinicalTrials.gov, the section listing the various criteria that patients must meet for enrollment commonly includes a line stating that patients with hepatitis B, hepatitis C or HIV are excluded. But under a new Food and Drug Administration draft guidance, that could change.

Issued Tuesday, it is part of a serious of draft guidances regarding cancer clinical trial eligibility criteria. While not binding, it suggests potentially allowing patients with HBV, HCV and HIV into clinical trials, as long as they meet certain conditions. Other documents in the series concern the minimum age for pediatric patients, organ dysfunction and cancer history, brain metastases and a final guidance on the inclusion of adolescent patients in adult trials.

Clinical trial design is a delicate affair. A key component is a study’s inclusion and exclusion criteria. These are the rules that govern which patients can enter the study based on considerations such as age, stage or severity of disease, various lab test results and more. If those criteria are too tightly defined, it can encumber patient recruitment, which in turn can slow down the trial and complicate plans like presentation and publication of data. On the other hand, eligibility criteria that are too loose can complicate interpretation of those data or even put patient safety at risk…