📈FDA Guidance on Overall Survival Assessment in Oncology Trials
Approaches to Assessment of Overall Survival in Oncology Clinical Trials; Draft Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Approaches to Assessment of Overall Survival in Oncology Clinical Trials." The purpose of this draft guidance is to provide recommendations to sponsors on the assessment of overall survival in randomized oncology clinical trials conducted to support marketing approval of drugs and biological products, with an emphasis on the analysis of overall survival as a prespecified safety endpoint. While the draft guidance discusses situations in which it is appropriate to consider overall survival for the primary endpoint, this draft guidance primarily focuses on statistical or design considerations when overall survival is not the primary endpoint.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The draft guidance impacts oncology clinical trials by providing recommendations for assessing overall survival, which can influence the design and statistical analysis of trials for marketing drug approvals. Business owners and executives in the pharmaceutical sector must consider these guidelines for compliance and product development strategies.