治験(臨床試験)の事前審査における検討内容の解析

概要

論文の詳細を見る
A prior review process was introduced in the Institutional Review Board (IRB) of the University of Tokyo Hospital to facilitate the evaluation of clinical trial plans for new drugs. This study summarizes the results of prior reviews of 73 protocols that were submitted to the IRB during 1999-2000. A total of 955 items were taken up for discussin at the prior review. Among them, 325 (34.0%) were related to the profile/description of investigational drugs themselves, and 252 (26.4%) were related to the trial plan. Major requests related to investigational drugs and givin to applicants after the prior review were on adverse reactions, pharmacodynamics, and pharmacokinetics. Items related to patient selection crieria and usage of concomitant drugs were major requests related to the protocol. In some cases, protocols were amended by applications in accordance with the requests. The study shows that the review of new drug clinical trial plans prior to the evaluation by the IRB and examination from a pharmaceutical viewpoint are meaningful and worthwhile.
社団法人日本薬学会の論文
2003-04-01