Drug Evaluation Committee 2009-57 Consent for Qualification Testing and Use in Other Studies
Related classification: Obtaining consent
First published: April 2010
Question
Recently, there have been increasing opportunities to include factors such as predictors of therapeutic efficacy in the development of antibodies and other products.
If the entry criteria for a clinical trial stipulate that a certain exploratory test result must be "positive" and it takes 10 days to obtain the test result, is it possible to create a separate Explanatory Consent Document (IC) for the test and an IC for participation in the trial after screening?
- This test is not routinely performed in normal medical practice.
- If the test result is "negative," you must wait 10 days for the test results before informing us that you are unable to participate in the clinical trial. Since this clinical trial targets patients with solid tumors for which no other treatment is available, there is a belief that we are depriving patients of treatment opportunities
- Since the probability of "negative" test results is high (a very large number of drop-outs are expected), we are wondering if it would be possible to reduce the burden on the implementing medical institution to simply explain the entire trial to all potential subjects
Also, when there is a separate IC for testing, is it possible to obtain multiple ICs for testing at the same time if there are multiple clinical trials, including those of other companies?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
We believe that there is no problem in obtaining explanation and consent for participation in the clinical trial in two steps ([1] consent for testing to confirm eligibility for participation in the clinical trial, and [2] consent for participation in the administration of the investigational drug once the patient is determined to be eligible).
Even in such a case, the explanation of [1] should include the fact that the test is intended for the purpose of participation in a clinical trial involving the administration of an investigational drug and information on the investigational drug (especially information on efficacy and safety), and if the test result confirms eligibility, the participation in a clinical trial as described in [2] should be explained again. If the patient is found to be eligible as a result of the test, it is necessary to explain that the patient's willingness to participate in the clinical trial will be confirmed again after the explanation of [2].
In addition, if there is a possibility that test results obtained by obtaining consent in [1] will be used by the investigator to make decisions on patient screening in other clinical trials, it is desirable to explain and obtain understanding of this fact as well. However, if the results are to be shared with another company's clinical trial, agreement with the sponsor of the clinical trial and review and approval by the Clinical Trial Review Committee are required.
Regarding your question about "obtaining multiple test ICs at the same time," although this is different from "exploratory testing," the contents of "Clinical Trials Using Genomic Pharmacology" (Pharmaceutical and Food Safety Bureau, No. 0930007, September 30, 2008) may also be helpful. The Q&A and the clinical trial Please take into consideration the Q&A presented in this notice and make your decision on necessary measures, etc.