Drug Evaluation Committee 2013-21 Review by the Clinical Trial Review Committee for additional/changed information on SAEs
Related classification: Clinical Trial Review Committee
First published: August 2013
Question
We would like to inquire about the review of reports (follow-up reports) on serious adverse events ("SAEs") by a clinical trial review committee established by a party other than the site of the study. If a follow-up SAE report is generated for a proposal for which a termination report has already been submitted, how should it be handled? The circumstances are as follows.
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1.In a prior comparative study, the complication diabetes worsened (without hospitalization).
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2.Subsequently, the subject entered a long-term study and was hospitalized due to further worsening of diabetes mellitus.
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3.The following observations of the sponsor led to a report (Report 1) as an SAE in the comparative study.
Sponsor's Opinion
The complication diabetes worsened during the comparative study and the adverse event "diabetes worsening" occurred, and the hospitalization in the long-term study was for further worsening of diabetes and is an adverse event that occurred during the comparative study, so it is reported as an SAE in the comparative study.
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1.A report of the end of the comparative study was made.
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2.Information was received that the subject was discharged from the hospital.
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3.A second report was prepared as an SAE of the comparative study, but since the completion report of the comparative study had already been made, a request was made to review the SAE report (second report) of the comparative study as a review item for the long-term administration study.
Also, if the termination report were to be submitted with the outcome unrecovered, what action should be taken? Is it possible to withdraw the termination report?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
In a case such as the one in question, the decision as to whether to treat the SAE as a comparison study or a long-term administration study should be made in accordance with the provisions of the protocol or the results of discussions with the sponsor. Since you have already reported the completion of the comparison study, there should be no problem in reporting this SAE, including the circumstances that led to the SAE report, as a matter for discussion in the long-term administration study that is currently being conducted, and have the IRB deliberate on it.
In addition, regardless of the case in question, there is no need to withdraw the termination report of this study even if new information regarding the SAE, such as a change in outcome, is reported in a study that was terminated with no recovery of the SAE outcome.