Generally, secondary endpoints are not included in drug labeling UNLESS the analysis is pre-specified, the study is powered for these endpoints, and/or they provide clinical support to the primary endpoint. There are a number of strategies that can be followed, including describing them as co-primary endpoints or analyzing them in a step-down manner. The disadvantage of co-primaries is that you take a statistical penalty for multiple testing, and the disadvantage of step-down analysis is that if the first test fails you are not allowed to analyze the remaining endpoints. There may be some leeway with patient reported outcomes that directly support a clinical endpoint, but you would need to discuss that with the authorities.
The bottom line is that the secondary endpoints have to follow the same "substantial evidence" of efficacy as the primary. I refer you to the following Guidance on Multiple Endpoints.
https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm536750.pdf------------------------------
Glen Park
Jersey City NJ
United States
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Original Message:
Sent: 20-Jun-2018 11:36
From: Anonymous Member
Subject: Secondary Endpoints
This message was posted by a user wishing to remain anonymous
Dear Forum-
How are secondary endpoints handled in drug labeling?
Thank you for your help!