Sunday, January 15, 2023 1:22:58 PM
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1852589/
When and How Can Endpoints Be Changed after Initiation of a Randomized Clinical Trial?
To evaluate whether a change in endpoint is independent of data from the trial, investigators and reviewers should ask three important questions. First, what is the source of the new information that elicits consideration of the change in endpoints? If the source is external to the trial in question, for example arising from results from another trial, then the revision of endpoints may be credible. Second, have interim data on the endpoint (or related data) from a trial been reviewed? If trial data have not been reviewed, then the revision of endpoints may again be credible. Third, and most importantly, who is making the decision regarding endpoint revision (e.g., trial sponsors or an independent external advisory committee)? Appropriate decision makers should have no knowledge of the endpoint (or related trial data) results. In particular, if interim analyses have been conducted, the decision makers should not have knowledge of those data
Even if NWBO had an IA, which they had not and you can not prove they had any, then still its irrelevant. As long as those making the decision to change the endpoints and how the changing of the endpoints should be handled, have no prior knowledge and are objective (Dr. Kevin Duffy the architect of the amended SAP) to any prior history of the trial (data) then thats acceptable. Thats why, as I have said here a few times before, is why Dr Bosch, as the CTO and architect of the original endpoints, moved back to Amsterdam to remove himself physically as far as he could from the changing of the endpoints.
It has absolutely NOTHING todo with Linda Powers you are completely and utterly CLUELESS
Recent NWBO News
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- Form 8-K - Current report • Edgar (US Regulatory) • 10/31/2025 04:29:10 PM
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