Drug Evaluation Committee 2008-19 How to include safety information in the explanatory document
Related classification: Obtaining consent
First published: January 2009
Question
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1.Each sponsor has its own method of describing side effects in the explanatory documents for subjects.
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2.Foreign sponsors generally list side effects by frequency, with more serious side effects (CTC grade 3 or 4 or higher) and serious side effects. Recently, they only list them roughly divided into X% or more and X% or less, and we ask them to identify and add serious side effects from the investigational new drug summary at our hospital. On the website of the Natoinal Cancer Institute in the U.S., I saw in the template that serious side effects should be written so that they can be identified, but in Japan, do we have to specifically mention serious ones? I believe that this information is necessary for patients. Also, which is better to include in the explanatory document, the severe or the serious one?
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3.The sponsor of a domestic clinical trial writes in a table the frequency of all grades and those that are severe (CTC 3 or 4 or higher). Sometimes I can't find a section called "serious side effects" from the investigational new drug summary, what is the data for such? Since the compensation is "only compensated in case of serious and unknown" in the case of anticancer drugs, do you interpret this as serious side effects = severe side effects?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Regarding your question 1
The explanatory document is to be prepared by the investigator, and the items to be included in the document are stipulated in Article 51, Paragraph 1 of the GCP. However, there are no guidelines regarding the details of each item to be described or the range of adverse reactions that should be described as you asked.
Regarding your question 2
The explanatory document must describe "anticipated disadvantages to subjects," but there are no provisions in the GCP ordinance or related notices regarding the scope and level of such disadvantages. The sponsor will provide materials and information necessary for the investigator to prepare the explanatory document. Based on these materials and information, the investigator prepares an explanatory document containing information that the investigator considers necessary to fully explain to the subject when he/she participates in the clinical trial. The investigational review committee will then deliberate on whether or not the content of the explanatory document is appropriate. Therefore, the investigator and the clinical trial review committee will determine the range and level of side effects to be described.
Incidentally, although this information is not intended to go beyond the scope of reference, the Pharmaceutical and Food Safety Bureau of the Ministry of Health, Labour and Welfare in its Notice No. 0630001 dated June 30, 2005, "Guidelines for Preparation of Drug Guide for Patients," provides the following information on adverse reactions, which should be immediately discussed with a physician The notice states that "all serious adverse reactions should be described" as symptoms that should be immediately reported to a physician.
Regarding your question 3.
Please check with the sponsor if there are any unclear points regarding whether safety information such as side effects described in the investigational new drug summary is appropriately described in the explanatory document. The scope of compensation also differs for each clinical trial, so please check with the sponsor.
Although there is no guideline on how to describe the consent document, if there are any points to keep in mind or Q&A on how to prepare the explanation document as a medical institution, it would make the preparation of the explanation document smoother if you publish them on your website or other places.