배경 및 연구 목적 : 1992년 이후, 중앙약사심의위원회 신약분과 임상평가소분과위원회(중앙약심)에서 담당해 온, 임상시험 계획서/보고서 심의의 관련된 제약업계 실무 담당자들의 의견을 조사하고, 문제점을 도출하여 개선 방향을 모색하고자 본 조사를 실시하였다. 조사 대상 및 방법 : 임상시험연구회원사(총 82개) 중 55개 사(68.3%)에서 임상시험 업무를 담당하는 72명으로부터 설문조사를 실시하였다. 설문서는 임상시험 업무 경험, 중앙약심 위원들의 전문성, 제약업계의 중앙약심 참여가능성, 심의의 비일관성, IRB 심의와의 불일치, 제약업계의 청문/설명 기회 보장, 심의 첫수의 적절성, 상설 기구의 필요성, 보건복지부 담당 공무원의 협조, 중앙약심 위원과의 사전 접촉 등을 묻는 문항으로 구성돼 있다. 허가용 임상시험의 담당횟수(2건 이하, 3건 이상) 및 중앙약심에 의한 총 피심의 첫수 (2건이하,
Background : The Central Pharmaceutical Affairs Council (CPAC) in Korea has reviewed protocols and study reports of registration clinical trials since 1992. A survey was conducted in order to collect industry's viewpoint of the CPAC's review, to find problems, and finally to suggest better ways of its review process. Methods : 72 people from 56 member companies of the Korean Society for Clinical Trial (total 82 companies) replied to the questionnaire. The questionnaire covered trial experience of respondents, CPAC's review quality and consistency, compatibility with Institutional Review Board(IBB)'s review, feasibility of industry's participation in CPAC as member, necessity of hearing by industry, standing committee, review frequency, satisfaction in regulatory official's coordination, and private contact with CPAC's member prior to the official review. Contingency table analysis was done according to the respondents' experience of registration trials (2 or less, 3 and more) and the number of submission for review (2 or less, 3 to 5, 6 or more). Results : The most frequently stated problems regarding the CPAC's review are overlapped and/or incompatble review result with IRB (24.0%), less frequent or delayed review (21.6%), and lack of hearing process by industry on the result of review (17.6%). The survey respondents regarded CPAC's review quality as intermediate (72.7% for therapeutic category and 54.5% for clinical trial related matters), and 34.8% of respondents evaluated CPAC's review standard, in terms of trial related matters, as low. In order to improve CPAC's review quality, ensuring quality experts (27.5%), industry's participation in CPAC as committee members (27.5%), and hearing by industry (23.0%) were suggested. To reconcile incompatible review results between CPAC and IRB, CPAC's review followed by the notification to IRB (53.6%), and industry's premeeting with CPAC (21.7%) were reported essential. 93.1 % of respondents felt CPAC should be run as a sort of standing committee to facilitate its review. Conclusion : To increase the CPAC's review standard and to make its review more accpetable to industries, it is strongly required to ensure experts having a balanced idea and experience in scientific, ethical, and practical aspects of clinical trial, and, in the long run, to operate the CPAC on a continual basis. In the current regulatory system, however, it is suggested to communicate interactively between CP AC and industries by accepting industry's clinical trial experts into CPAC and by securing industry's hearing possbile when neeeded.
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