I know a company sponsor can use an IIT -- independent investigator initiated trial for an investigational agent as the proof of concept for the basis of a phase 3 trial design, correct? Drug is being supplied to the investigator. Does the company sponsor need to discuss this up front with the Agency if planning for use in designing a registration trial? Can a company assist in the protocol review or medical writing support? What expectation to the data access after completion is there and in what form should the sponsor recommend to the investigator with assurance the study was conducted under GCP.Meaning if this is independent and the investigator is inclined to do it but seeks a bit of advice from the co, how does this work?Thanks for any input from experience.
Good assessment from Glen. I'll just add that the process is very much the same for devices (i.e., physician-sponsor IDEs).
Also, there may be a need for the device manufacturer to make non-clinical safety data available for FDA review and approval of the PS-IDE. Although these data could in theory be provided to the physician sponsor for use in their submission, in practice it's typically done by way of a device master file (MAF) or by reference to a company sponsored IDE.
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