Drug Evaluation Committee 2015-18 Prescreening of Other Clinical Trials During Clinical Trials
Related classification: Incorporation of subjects
Date of first publication: December 2015
Question
We have a question regarding the possibility that a subject who is participating in a clinical trial may be asked to participate in a genetic prescreening of another clinical trial. The subject was enrolled in Company A's clinical trial and is still receiving the investigational drug, but the physician has asked if the subject can participate in a genetic prescreening for Company B's clinical trial. You can participate in this clinical trial regardless of whether or not you have gene expression status.
The consent forms for the prescreening and the main consent are different, and to participate in Company B's clinical trial, the gene expression is confirmed in the prescreening and the consent form for the main consent is signed. Company A, the sponsor, has confirmed that "there is no problem in obtaining consent for prescreening consent for other clinical trials if no other clinical tests or evaluations will be performed for the clinical trial. In this case, we are submitting stored tissue, and we have determined that no interventions or AEs for Company B's clinical trial will occur. We have determined that no intervention or AE will occur.
- Under these circumstances, is there a problem with obtaining pre-screening consent and submitting preserved tissue while participating in Company A's clinical trial?
- Is double entry of subjects prohibited under GCP?
- Is there a problem with Company B's clinical trial CRA having access to source documents related to Company A's ongoing clinical trial?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Since we do not know the details of the trial in your question, we would like to offer our opinion in general terms.
Although there is no clear provision in GCP regarding the double entry of subjects, the "General Guideline for Clinical Trials (April 21, 1998, Pharmaceutical Affairs Bureau, Ministry of Health and Welfare, Notification No. 380)" states that "As a general principle, subjects should not participate in more than one clinical trial at the same time (exceptions may be justified). This is to ensure the safety of subjects and to protect clinical trials. This is considered to be for the purpose of ensuring the safety of subjects and proper evaluation of the investigational drug. Based on this, we believe that the following matters need to be taken into consideration.
- Specimens are not collected during the period of participation in Company A's clinical trial (impact on the safety evaluation of Company A's clinical trial)
- The results of gene analysis are not notified to the site (impact on the efficacy evaluation of Company A's clinical trial).
- Specimens are not collected only for Company A's clinical trial (specimens and rights to intellectual property derived from them) If specimens are collected only for Company A's clinical trial, obtain Company A's consent to use them for Company B's clinical trial.
In any case, it is important to confirm the provisions regarding double entry into other clinical trials in the clinical trial protocols of both companies, and it would be necessary to discuss the implementation of such pre-screening with both Company A and Company B.
Even if the source documents are related to Company A's clinical trial, if they need to be confirmed during the monitoring of Company B's clinical trial, they should be made available for inspection by Company B. In this situation, it would be necessary to discuss the implementation of such pre-screening with both Company A and Company B.