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  49455 of 50121  at  5/15/2019 7:23:31 PM  by

GaryM


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.

I don't know if the correct number is 100, 200, or 50, but my point is, if the FDA said we'd be satisfied with 300 patients in the trial, if we had 150 who previously underwent the same protocol, why shouldn't they accept 150 more which should dramatically lower both the cost and time required to run the trial.

I'm not saying this is the case, or that the company may not wish to change the protocol, but if the protocol either remained unchanged, or could consider the existing patients to be in compliance with any changes, it would seem reasonable to include them.

Gary


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Replies
Msg # Subject Author Recs Date Posted
49459 Re: Could the applicable patients in the current Phase 3 Trial be added to a new trial. erniewerner 0 5/16/2019 4:52:13 AM






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