薬理と治療

Abstract

Background Because the quantities of information are increasing in the informed consent of investigational drugs, an informed consent form of more than 30pages is not rare at the present. It seems to be difficult for depressive patients to understand such kind of document and do the decision making of the participation in clinical trials as a subject. This study was performed to know the desirable method that was better than the current information presentation method in the informed consent form of investigational drugs for depressive patients. Methods The explanation document consisting of 27 pages in size of A4 which was generally used and the explanation document consisting of three parts with a quantity same as the former one were made. Part 1 was“concise explanation document about the clinical trial in general”, part 2 was“explanation document about the clinical trial concerned”, and part 3 was “supplement explanation document for the patient who wanted to know more detailed information”. Using these two kinds of explanation document, the survey was performed to clarify about an impression called“easy to read”,“friendly”, and “easy to understand”in 20 depressive patients compared with 61 healthy Japanese citizens. Results The depressed patients felt that the document consisted of three parts was more “easy to read”,“friendly”, and“easy to understand”, than healthy Japanese citizens. Conclusions It is necessary for the current explanation document in informed consent form of investigational drugs to be devised depending on the pathological condition of depressive patients.