Drug Evaluation Committee 2016-22 Disclosure of Clinical Trial Information after Clinical Trial Completion
Related classification: Other
Date of first publication: August 2016
Question
Recently, we have received requests from several cooperating departments to provide information, if possible, on the results of clinical trials after their completion, including the approval status of investigational drugs conducted at our hospital.
We believe that the cooperation of various departments within the hospital is indispensable when conducting clinical trials, and that providing such information on the results of clinical trials will serve as an incentive for the cooperating departments. Therefore, we would like to continuously provide information to cooperating departments in the future, and are considering providing information such as the fact that an investigational drug for which we have been conducting a clinical trial has been approved for marketing or that its development has been discontinued, through newsletters published in the hospital and lectures for staff members, etc. We are considering providing information such as "Approval for marketing" or "Discontinuation of development".
We believe that the marketing approval is public knowledge, but on the other hand, the confidentiality of the clinical trial agreement states that regardless of the term of the agreement, "The First Party shall not divulge to any third party any materials or other information disclosed by the Second Party regarding this clinical trial or any information obtained as a result of this clinical trial without prior written consent from the Second Party. The above is the same as the above. As stated above, is it acceptable to disclose information including (1) the name of the investigational drug code, (2) the fact that the clinical trial was conducted at our hospital, and (3) information regarding the results of the clinical trial (e.g., marketing approval obtained, development discontinued), mainly to hospital staff, in order to maintain confidentiality? Is it necessary to obtain the consent of the sponsor in advance or take other measures when providing such information? Newsletters and lectures are intended for all employees, so information will be provided to departments and employees who are not necessarily collaborating in the clinical trial. In addition, newsletters may be distributed to related facilities outside the hospital, etc., and lectures may be attended by people outside the hospital.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
In the case of the contract in question, since the contract is between the sponsor and the investigational organization, disclosure of information on the clinical trial to the staff of the medical institution, including departments and staff who are not cooperating in the clinical trial, does not constitute disclosure to a third party and would be acceptable, but it is necessary to take measures to maintain confidentiality. However, it is necessary to take measures to maintain confidentiality.
On the other hand, distribution of materials to facilities outside the hospital and lectures attended by persons outside the hospital correspond to disclosure of information to a third party as defined in the relevant agreement, so disclosure other than information that is public knowledge is not allowed.
Since it may be difficult to determine whether some information is public knowledge or not, it is desirable to obtain the consent of the sponsor in advance when disclosing such information.