第I相試験の健康成人ボランティアを対象とした治験に対する意識調査

抄録

After the renovation of Good Clinical Practice (GCP), the industrial sponsors and medical institutions have improved their practice. However, the clinical trials greatly depend upon the understanding and cooperation of participating volunteers. The survey of Kobayashi et al. on Phase II/III Trials, revealed that participating patients generally had a good impression. We conducted a questionnaire on healthy volunteers to clarify whether a difference may exist.
Those who participated in a Phase I Trial after April 2001 at the six participating institutions were enrolled in the study. The questionnaire covered 31 topics related to the impression before and after participating in their first trial, general impression on the trial and others from between October 2004 and January 2005. Analysis of the data (without personal information) was conducted at St. Marianna University.
Healthy volunteers had almost the same impression of Clinical Trials as diseased patients in Phase II/III Trails. The study revealed that they wished for trials for new drug development to widely inform the public, and be carried out safely, but also in an active manner. We concluded that it is important to keep ourselves attentive to the public/volunteer opinion, and to continue to carry out good practice in Clinical Trials with a good relationship between and cooperation of volunteers and patients.