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Pre-planned extension studies
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Re: Guidance Regarding Duration of Clinical Trials Used as Reference Support in Advertising
Can you elaborate on as to what demonstrates that an extension study was pre-planned? If there was a registered protocol and after primary trial completion, participants were invited to register for the long-term extension, does that qualify as pre-planned? If yes, would publication of a post hoc interim analysis of that pre-planned extension study qualify under the guidance, or would only the final analysis qualify as reference support?
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Great question @keoca
“Pre-planned” means “planned at least prior to the initiation of the extension”. Post hoc, ad hoc, and exploratory analyses are not acceptable. In other words, any of the following would support “pre-planned” with regards to the extension:
a) if the parent published study’s methodology section includes the a priori plan for the extension
b) if the parent study protocol (data on file) includes the plan for the extension
c) if a separate published paper for the extension includes the a priori plan for the extension
d) if a separate extension protocol (data on file) includes the plan for the extension
Timepoints before the end of the extension study (if any) when findings will be examined, should also be pre-planned.
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@jennifer-carroll This is great info. It is really helping us to understand the new guidance. I have a follow-up question regarding "Timepoints before the end of the extension study..." If the extension study protocol identified that data will be analyzed before the end of the extension study, but does not identify when, is that sufficient to qualify as a pre-planned analysis?
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Afternoon @keoca
No that would not qualify. Specific timepoints must be clearly indicated as pre-planned.
