FDA Releases Multiple Guidance Documents Specific to Cancer Clinical Trials
(Thursday, March 3, 2022)
As promised, FDA released three new guidance documents specifically intended to help cancer drug development. These guidance documents cover common areas of concern in cancer clinical trials such as inclusion of older patients, concurrent recruitment of multiple cohorts to test the drug in multiple presentations of cancer in the same trial, and master protocols. These guidance documents were apparently created quickly to address common comments from patients fat previous FDA public hearings. Like most FDA guidance documents, these are non-binding recommendations but having them should give sponsor comfort to expect FDA support when applying them on their trials. However, sponsors would need to self-motivated to follow the advice as the guidance documents provide little new information. For example, FDA’s guidance on including patients older than 75 years of age in Phase 1 and early clinical trial is pretty cryptic with making very generic comments about the importance of including older patients. Similarly, FDA guidance on expansion cohorts and master protocols point to well-established information already employed based on previous guidance documents. Still having additional guidance documents can only help sponsors on the fence to apply these principles on their trials.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC