GCP実施後の治験時におけるインフォームド・コンセントに対する患者・医師の意識 The Present Opinion of Patients and Doctors toward Informed Consent for Clinical Trials following the Implementation of "Good Clinical Practice"
Three years have passed since the enforcement of GCP (good clinical practice). Weinvestigated the understanding and reaction of patients and doctors toward informedconsent for clinical trials. The questionnaires were given to outpatients in our clinic anddoctors in our clinic as well as in our related clinic. Regarding knowledge of clinicaltrials, 48% patients did not know that clinical trials are undertaken in order to developnew drugs. It took less than 10 minutes for 51% of the patients to agree to informedconsent and for 67% of the physicians to obtain a consent. Interestingly, 44% of thepatients consistently signed the written informed consent and 28% of the doctors alwaysobtained consent. In conclusion it is necessary to establish the patient-doctor relationshipthrough adequate information. Informed consent is an important integral part of clinicaltrials which are critical for the development of the field of medicine.
- 臨床薬理 = JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
臨床薬理 = JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS 26(4), 897-902, 1995-12-31
The Japanese Society of Clinical Pharmacology and Therapeutics