Cancer Trials: US FDA Expands Scenarios Where Placebo Design Needs Justification
Executive Summary
Sponsors should justify use of a placebo control when primary adverse event prophylaxis is required, there exists an available therapy, or when placebo is given as monotherapy, agency says in final guidance applicable to randomized controlled oncology trials.
You may also be interested in...
Guidance By Guidance, US FDA Is Reshaping The Look Of Cancer Drug Trials
Recent draft guidance documents address adolescent enrollment in adult cancer trials, use of cohort designs in early-phase studies, and inclusion of placebo controls; more advice is coming soon on master protocols, adaptive designs and novel endpoints, FDA's Gottlieb says.
Antisense Oligonucleotide Clinical Guidance Emphasizes Individualized Nature Of Treatment
US FDA’ s latest ‘n of 1’ guidance describes clinical considerations for INDs to support dosing and monitoring of an individual with a life-threatening genetic disease who is eligible to receive an ASO; recommendations apply only when a few patients may be candidates for treatment.
Real-World Data: FDA Urged To Distinguish Between Electronic Health Records And Medical Claims
Comments on September draft guidance seek more attention to differences between the two types of data sources; pharma firms said they may not always have access to all the information the US FDA wants to see about a particular data source, and they seek additional flexibility on validation.