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Re: exwannabe post# 693204

Wednesday, 05/22/2024 11:11:36 AM

Wednesday, May 22, 2024 11:11:36 AM

Post# of 827974

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.

You are a liar you tell lies lies lies. And you are ignorant.

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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