Wednesday, May 22, 2024 11:11:36 AM
The FDA says that changing the endponts based on information from the trial is a big no-no. And the results of an IA is huge wrt the likelyhood f the initial endpoints failing.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1852589/
When and How Can Endpoints Be Changed after Initiation of a Randomized Clinical Trial?
https://www.researchgate.net/publication/6385936_When_and_How_Can_Endpoints_Be_Changed_after_Initiation_of_a_Randomized_Clinical_Trial
https://www.clinicaltrialsarena.com/features/changing-primary-endpoints-in-clinical-trials-proceed-with-caution/?cf-view
If the original primary endpoint is no longer the most appropriate endpoint due to new knowledge or events, then changing the endpoint may be appropriate, Booth elaborates. However, the reevaluation should occur in conjunction with a data safety monitoring committee and input from trial leadership.
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