治験実施に際しての事前審査における薬剤師の役割

概要

論文の詳細を見る
A prior review system for clinical trials was introduced into The University of Tokyo Hospital in March 1999, for the purpose of supporting the Institutional Review Board(IRB). In this study, we investigated the effect of this system on IRB, and evaluated roles of pharmacists involved in utilizing this prior review system. An average period from the acceptance of regular application of each protocol to the approval of IRB was 1.7 months, and the period was significantry shorter than that before the introduction of this system(2.3 months). On the other hand, the number of instructions given to applicants increased to be 2.8 times before the introduction of this system, suggesting the improvement of the quality of this prior review system. In the prior review, the number of instructions pointed out from pharmacists concerning pharmacokinetics, pharmacodynamics, drug-interactions, adverse reactions, and the other matters related to investigational drugs was greater than that from doctors or nurses. According to the results of the surveys for doctors, nurses, and other clerical employees, pharmacists were indicated to review from a Pharmaceutical point of view and their review was found to be very important. In conclusion, the prior review system was considered to be useful for the rational practice of clinical trials and pharmacists were recognized to be indispensable as reviewers on the prior review.
社団法人日本薬学会の論文
2001-09-01