Could the applicable patients in the current Phase 3 Trial be added to a new trial. | IMGN Message Board Posts

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Msg  49459 of 49707  at  5/16/2019 4:52:13 AM  by

erniewerner

The following message was updated on 5/16/2019 4:53:04 AM.

 In response to msg 49455 by  GaryM
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Re: Could the applicable patients in the current Phase 3 Trial be added to a new trial.

 "If the protocol remained the same, and if say 100 patients in the current trial would qualify for the new trial, would it be possible to do the trial with 100 fewer patients, and consider the result for the existing 100, who would also provide substantially longer survival data."
 
You have to remember that a clinical trial is the embodiment of the "scientific method."  You start with a hypothesis and then design a stand alone experiment to attempt to prove the hypothesis is correct.  How blinded or randomized is a trial when you already know the results for the first 100 or so enrollees?  The high FR alpha subset data from Forward 1 will be supportive evidence and will be part of the NDA package when it is submitted, but IMGN has to start at the beginning and come up with a new trial.  Presumably they will have a head start and use the same CRO and many of the same sites and clinicians as Forward 1 and it will likely be a smaller N, with a PFS primary and OS secondary endpoints. 
 


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Msg # Subject Author Recs Date Posted
49462 Re: Could the applicable patients in the current Phase 3 Trial be added to a new trial. Bibliobiftek 1 5/16/2019 9:06:20 AM


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