Yes in P2/3 trial the data will have be examined at some pre-specified point and adaptations made for the P3 stage based on the data.
This I believe also means that all patients must have passed the P2 stage in order to process all the data and enter P3 all remaining patients at the same.
It then may be possible that extraordinary results in the P2 data could to lead approval, but probably more likely that the P3 confirmatory stage needs be completed with any adaptive changes being verified.
Apologies for the formatting issues but this source has me closer to understanding the process than I was before. Seems it might make determination of success/failure more difficult until the completion of the Phase 3 portion of the trial imho.
“In one sense, theseamless design can be interpreted to have anadvantage compared to the conventional sepa-rate-phase paradigm, in which phase II resultswill often be known broadly and in much detailprior to the phase III trial. One of the argumentscited in support of confidentiality conventionsinvolves equipoise, the desire for trial partici-pants such as investigators to have reasonablyneutral predisposition regarding the compara-tive merits of treatments in the study; by limita-tion of knowledge of learning phase results(which, for example, may be highly suggestive ofadvantage for an experimental treatment),seamless designs may offer advantages over tra-ditional separate-phase programs in this regard.Additional precautions should also be con-sidered and implemented as feasible to limitthe information that observers can infer from aparticular selection decision. As an example,while the trial protocol should provide some ra-tionale for the selection decision to be made,full statistical details may be withheld from theprotocol and described in a document of muchmore limited availability (as long as these de-tails are not judged important enough for re-view boards, investigators, or patients to re-quire knowledge of to understand the trialadequately). In many circumstances, selectionmay be a complex process involving a number offactors and not simply results on key efficacyendpoints (safety, compliance, marketing con-siderations, etc.), and this will further limitwhat observers are able to infer specificallyfrom knowledge of the selection decision “
PS. Thanks for the clarification Doc. Hopefully the hair growth locations can be tightly controlled. I’m imagining supercharged ear hair growth turning folks into Princess Leia side bun lookalikes. :-)
News 
Market Data 
Discover 
AI
