[Getting informed consent in clinical trials on Japanese cancer patients].
According to the survey in the spring, 1995 of the Minister of Health and Welfare, only 20% of recently died patients had been told the truth, having cancer, in Japan. This suggest that most of clinical trials on cancer in Japan involved patients without real Informed consent (IC) from patients themselves. Recent effort of the Japanese Clinical Oncology Group are breaking through this situation. In the first part, principles of IC in cancer patients and IC in trials were explained. Then the results of a questionnaire are shown. From my personal experience of over 700 patients told the truth, all that doctors should tell to patients in western countries could be told without causing troubles even in Japan. The results of the questionnaire answered by 388 patients of various cancers treated by the author, showed clearly the feasibility of telling the truth to Japanese cancer patients. This has long been regarded impossible or unacceptable. Only 2% of them regretted to be told the truth, only 7% did not desire to know the prognosis, more than 90% wanted to be told that they have recurrence when they would have recurrence. Even when they would be incurable, 66% of them required to be told so and only 16% did not. In such difficult situation, 36% would insist anticancer treatment, while 41% would prefer best supportive care. No one but patients themselves can make this choice.
Sasako
M
M
Dept. of Surgical Oncology, National Cancer Center Hospital, Japan.
D000328:Adult; D002986:Clinical Trials as Topic; D017041:Ethics Committees; D006801:Humans; D007258:Informed Consent; D007564:Japan; D008875:Middle Aged; D009369:Neoplasms / Q000628:therapy*; D010344:Patient Advocacy; D014342:Truth Disclosure