Patient Response toward a Clinical Trial when They Are Informed Strictly According to the Ethical Guidelines of GCP (The Standard of Clinical Trial for Medicine).

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Objective: The ethical requirement of GCP (the Standard for Clinical Trial for Medicine) confronts physicians with the dilemma of obtaining informed consent prior to trials. The patient response when physicians requested patients to participate in a trial strictly in obedience to the GCP ethical guidelines was investigated in the present study.<BR>Subjects: All patients admitted to the department of Hematology/Oncology of the Second Tokyo National Hospital, with hematologic disorders during the 5 month period of the present study.<BR>Method: Patients were asked about their response toward a hypothetical trial of intra venous antibiotics that would be a double-blind, randomized trial using an active drug as control. To standardize the manner of informing the patient about the trial, a recorded explanation about the trial was given to the patient; the patient could then discuss withthe interviewer.<BR>Results: Fifty-four (68%) of 79 patients interviewed agreed to participate in the trial, and 25 (32%) refused. The two major motivations to enter the trial were altruism and the patient-physician relationship, and the main reason not to enter was anxiety, especially about adverse drug reactions. Twelve patients (15%) stated they had an ill feeling about the randomization, and 17 (22%) stated the same about the double-blind procedure. People who were more willing to enter the trial, did not have a negative feeling towards a double-blind trial, were elderly, had stayed longer in the hospital, and had experienced parenteral antibiotic therapy.<BR>Comments: This kind of study can investigate the influence of ethical requirements like GCP on clinical trials and can make physician more comfortable with GCP.
一般社団法人日本臨床薬理学会の論文

Patient Response toward a Clinical Trial when They Are Informed Strictly According to the Ethical Guidelines of GCP (The Standard of Clinical Trial for Medicine).

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