Drug Evaluation Committee 2014-13 Review of Clinical Trial Review Committee for Extension of Clinical Trial Duration
Related classification: Clinical Trial Review Committee
Date of first publication: Jul 2014
QUESTION.
The sponsor has informed the hospital of a change in the clinical trial protocol due to a change in the trial implementation period, etc.
Clinical trial protocol: Clinical trial period: until August 31, 2014
(Incorporation period until July 31, 2014)
Contract period: until August 31, 2014
However, the hospital did not hold a Clinical Trial Review Committee meeting in August, and changes to the study period are not subject to expedited review. Since the change to the study protocol was finalized three days before the July Investigational Review Board (IRB) meeting, it is difficult to review the change at the July IRB meeting. We are considering one of the following options
- 1.By the end of August, change the contract period to the end of October
We believe that this method does not require IRB review because it is simply an extension of the contract period. - 2.We are considering changing the contract to match the extension of the trial period after the September IRB approval of the change to the trial protocol.
Is it acceptable to temporarily suspend incorporation from August 1, and resume incorporation after IRB approval in September? Also, is there anything else we should be aware of in this case?
Opinion of the Pharmaceutical Manufacturers Association
The change of the contract period is not a matter for deliberation by the Clinical Trial Review Committee, and therefore, it is acceptable to take action through discussion with the sponsor.However, changes to the trial period or the period of subject enrollment require the approval of the Clinical Trial Review Committee (including approval through expedited review) as a change to the protocol, and not only the enrollment of subjects after August 1, but also the implementation of the trial (e.g., medication and observation of subjects) after September 1 are not allowed.
While your comments are correct in regard to the subject enrollment, please note that the implementation of the clinical trial (medication to subjects, observation, etc.) must also be suspended after September 1.
In this regard, although the review will not be completed in time for the July Clinical Trial Review Committee meeting, it would be desirable to respond flexibly so as not to affect the implementation of the clinical trial as much as possible, such as by considering holding the meeting on a temporary basis.
In general, minor changes to a clinical trial can be approved through expedited review, so we recommend that you revise the Trial Review Committee's procedures so that it can respond flexibly in light of the definition of "minor change" as "a change that does not affect the conduct of the clinical trial, is not likely to cause mental or physical harm to the subject, and does not increase the risk to the subject. It is recommended to revise the procedures of the Clinical Trial Review Committee so that it can be changed flexibly in light of the definition of "not increase the risk to subjects without the possibility of mental and physical harm to subjects to the extent that it does not affect the conduct of the clinical trial.