Final Clinical Cancer Trial Guidances Issued By FDA

Three new final guidances for cancer trials have been released by the US Food and Drug Administration (FDA), which build on the Biden Administration’s recent push to revamp its Cancer Moonshot initiative, originally launched by Biden as Vice President in 2016. The first guidance recommends that patients 65 and older be included in clinical trials for new treatments. It provides recruitment strategies, trial designs, and more.

The second guidance, according to Fleur Jeffries of PM Live, is, “Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics, which provides advice on designing and conducting trials with multiple expansion groups. Researchers and pharmaceutical companies can use trials with expansion cohort design to evaluate various aspects of a drug in a single clinical trial to efficiently action the clinical development of the drug”

Click here to learn more about the guidances.

(Source: PM Live, March 3^rd, 2022)