Drug Evaluation Committee 2015-27 Presentation of medical information at the time of participation in past clinical trials in direct access to original documents
Related classification: Record keeping
Date of first publication: December 2015
Question
I would like to ask a question regarding the provision of information to a clinical trial sponsor.
A patient who previously participated in a clinical trial of another sponsor has decided to participate in a clinical trial of another sponsor. At that time, he asked to see the data and worksheets from the previous clinical trial (not only the clinical trial, but also all post-marketing studies, etc.).
I refused, saying that I could not show them to him due to confidentiality obligations, but he asked me again to show them to him to check his eligibility. However, the contents of the eligibility could be sufficiently confirmed by in-hospital inspection, so I responded in the same way.
Is it necessary or obligatory to show data from clinical trials or clinical studies in which I participated in the past?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Your question seems to be about how to consider the obligation of confidentiality as a medical institution regarding clinical trials conducted in the past (Article 13, Paragraph 1, Guidance 3 (17) (iv) of GCP) and the obligation to present original materials to the sponsor (Article 13, Paragraph 1, Guidance (14) of GCP).
As you understand, there is an obligation of confidentiality as an investigational medical institution with respect to information related to clinical trials (excluding information that is public knowledge), such as information related to the study protocol, investigational new drug summary, explanatory documents, etc., properties, preparation method, dosage and administration, efficacy and safety of the investigational drug. However, the information contained in medical records and worksheets is a record of the results of the clinical trial and is limited to information related to the clinical trial as described above, and therefore, the sponsor's intellectual property rights do not usually extend to it.
Therefore, we believe that there is no problem in providing the data of past clinical trials, etc., described in medical records and worksheets for inspection by the relevant sponsor. We recommend that the sponsor and the investigator discuss how to respond to the request.