Drug Evaluation Committee 2014-13 Review by the Institutional Review Board Regarding the Extension of a Clinical Trial Period
Related Category: Institutional Review Board
Initial Publication Date: July 2014
Question
In a trial currently under contract, the situation is as follows. Due to changes in the clinical trial period and other details, the hospital has received notification from the sponsor regarding an amendment to the clinical trial protocol.
Clinical Trial Protocol: Trial Period through August 31, 2014
(Enrollment Period: Through July 31, 2014)
Contract Period: Through August 31, 2014
However, our hospital does not hold an Institutional Review Board (IRB) meeting in August, and changes to the clinical trial period are not eligible for expedited review.Since the amendment to the clinical trial protocol was finalized just three days before the July Institutional Review Board (IRB) meeting, it will be difficult to review it at the July IRB meeting. We are considering one of the following options:
- 1.Change the contract period to end on October 31 by the end of August
. Since this is simply an extension of the contract period, we believe IRB review is not required. What do you think? - 2.We are considering having the September IRB review and approve the amendment to the clinical trial protocol, and then amending the contract terms to reflect the extension of the trial period.
As a measure, we plan to temporarily suspend patient enrollment starting August 1 and resume enrollment after IRB approval in September. Would this be acceptable? Also, are there any other points we should be aware of if we proceed with this approach?
JPMA Opinion
Since changes to the contract term are not subject to review by the Institutional Review Board (IRB), you may proceed by consulting with the sponsor without waiting for IRB review.Furthermore,changes to the clinical trial period and the subject enrollment period require IRB approval (including approval via expedited review) as amendments to the clinical trial protocol. Consequently, not only will subject enrollment after August 1 be prohibited, but clinical trial activities (such as administering medication to subjects and monitoring) after September 1 will also be prohibited.
While our response regarding subject enrollment aligns with your feedback, please note that we will also be forced to suspend trial operations (including administration of medication to subjects and monitoring) starting September 1.
In this regard, while we understand that the review will not be completed in time for the July Institutional Review Board (IRB) meeting, we believe it would be desirable to respond flexibly—such as by considering an extraordinary meeting—to minimize any impact on the conduct of the clinical trial.
Furthermore, since minor amendments related to clinical trials can typically be approved through an expedited review process, we recommend revising the IRB’s standard operating procedures to allow for flexible responses in accordance with the definition of a “minor amendment”—namely, “one that does not affect the conduct of the clinical trial, poses no risk of psychological or physical harm to participants, andand do not increase the risk to subjects,” we recommend revising your Institutional Review Board (IRB) procedures to allow for a flexible approach to such changes.