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わが国における治験実態および患者満足度調査―治験参加前,治験参加後,今後の治験への期待―
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Abstract
Patient centricity is one of the most important concept whenever we conduct clinical trials. In recent years, several publications about patient insight have been reported and referred to improve patient experience and clinical trial process in the world. We conducted the web‒based survey with patients who have experienced to participate in Japanese clinical trials to understand their insight /feeling /satisfaction /expectations and real circumstance around clinical trials. 1364 patients participate the web‒survey. 83.4% of the total was completed the clinical trials while 16.6% was dropout before completion. Total satisfaction(score 0:worst―score 10:best)of clinical trial was 35.2% for high(score:10‒8), 54.9% for middle(score:7‒4)and 9.9% for low(score:3‒0). As the advantage of the clinical trial, compensation was 50.7% and medical expense deduction was 45.6% while time commitment was 23.4% and transportation burden was 22.3% as the disadvantage. As the expectations for future clinical trials, to have personal medical record during the clinical trial was 81.4%(very helpful and helpful)and to see clinical trial outcome was 76.4%.This survey showed that there are various types of burden, needs and expectations at any stage from before to after the clinical trial. In order to make Japanese clinical trials more accessible and improve patient enrollment and retention at minimum study drop‒out, it is important to establish the work flow to continuously incorporate participants’ voice into the study improvement process and proactively support them.
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