Drug Evaluation Committee 2016-36 Indication of target disease names in the recruitment of test subjects
Related classification：Recruitment of human subjects
Date of first publication: October 2016
Question
We would like to ask you about the materials for recruiting subjects that you plan to publish on the hospital's website.
The target disease is a generic name for cancer of three sites, and this generic name is used in the study protocol and in the explanatory documents for subjects. Only the generic name is used, and there is no mention of the name of the disease for each site, such as "(area name) cancer. The physician wishes to include the name of the disease for each site in the recruitment description because it is likely to be searched for by the name of the cancer for each site, but the sponsor wants the disease name to be listed as in the study protocol.
Is this a deviation from the "Disclosure of information on clinical trials can be conducted within the scope indicated in the consent and explanation documents and the study protocol" as stated in the Pharmaceutical Manufacturers Association of Japan document "Guidelines for providing information for recruiting subjects for clinical trials" and "2.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The "Guideline for Provision of Information for the Recruitment of Subjects for Clinical Trials" (revised version) (November 2008) indicates how information should be provided when recruiting subjects for clinical trials, while taking into consideration the prohibition of advertising of unapproved drugs under the Pharmaceuticals and Medical Devices Act and the advertising regulations for medical institutions under the Medical Care Act. Therefore, the "name of the target disease and symptoms" when providing such information can be provided to the extent indicated in the explanatory documents and clinical trial protocols, taking into consideration the above regulations.
If it is considered difficult for subjects to understand the names of target diseases as described in the protocol, it is acceptable to use terms that are easier to understand without going beyond the scope described above.
It is important to provide information that is beneficial to subjects in an appropriate and easy-to-understand manner, so we believe it is best to determine the terminology to be used after consultation with the sponsor.