I think the lack of specific guidance is because there isn't much to say beyond what is already in the regulations:
812.40 General responsibilities of sponsors
...ensuring that any reviewing IRB and FDA are promptly informed of significant new information about an investigation.
The fact that the sponsor is terminating the investigation meets the criteria of "significant new information" about the investigation.
812.150 Reports
(7) Final report. In the case of a significant risk device, the sponsor shall notify FDA within 30 working days of the completion or termination of the investigation and shall submit a final report to FDA and all reviewing the IRB's and participating investigators within 6 months after completion or termination. In the case of a device that is not a significant risk device, the sponsor shall submit a final report to all reviewing IRB's within 6 months after termination or completion.
Once the FDA receives notification under 812.40, they may ask for specific information to be included in the final report that is to be submitted under 812.150. The IRB may have some specific requests also.
David refers to "voluntary withdrawal." This refers to the IDE. The IDE may need to be left open until the final report on the investigation has been submitted; otherwise, the final report may have no place to go administratively. I'd just submit the notification of termination and then wait for FDA to respond before trying to withdraw the IDE. They might do that automatically upon receipt of the final report.
I can't think of any reason the sponsor can't tell investigators to stop enrollment as soon as the decision is made to terminate the study, but I would not make any changes in how patients who are currently enrolled in the study are treated and/or followed until I heard back from the IRB and FDA. The premature suspension of treatment per the approved protocol can sometimes be medically unwise; the investigators can probably advise the sponsor regarding whether this is likely to be a concern. Follow-up often serves to monitor the welfare of patients who have been exposed to an unapproved device; the need for that doesn't necessarily go away simply because the sponsor has decided not to enroll any more patients.
I would address these issues in the notification to both the IRB and the FDA. If you don't think it post any risks to enrolled patients to discontinue treatment or follow-up, I suggest that you state your intention to do this in the notification, and include the justification.
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Julie Omohundro RAC
Durham NC
United States
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Original Message:
Sent: 12-18-2014 05:12
From: Mark Paquin
Subject: Voluntary early termination of an IDE
HI everyone,
I'm hoping someone will be able to provide guidance. One of my clients is a sponsor of an IDE. They are three years into the trial and have recently decided to no longer pursue the PMA for their device. As a result, the sponsor would like to terminate the trial. The thing is however, there's no guidance or information in the IDE regs that specifically relate to voluntary early termination of an IDE. I'm sure a sponsor terminated IDE isn't uncommon and am hoping someone may be able to shed light on this for me.
Thanks in advance,
Mark
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Mark Paquin
Miami Beach FL
United States
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