global clinical trialsとは 意味・読み方・使い方

However, several issues still need to be resolved in order for Japan to gain a certain level of recognition as an environment in which to conduct clinical trials from a global standpoint.例文帳に追加

しかしながら、わが国が治験を実施する環境として世界的な視点から一定の評価を得るためにはまだ解決すべき課題がある。 - 厚生労働省

In particular, as the streamlining of clinical trials, etc., require detailed reviews, a "Working Group Regarding the Streamlining of Clinical Trials, etc." was established, and reviews centered on the three main items of cost, speed, and quality were conducted. Although steady overall improvements were seen due to efforts made by the relevant parties thus far, it was shown that there are issues that still need to be resolved in order for Japan to receive a certain level of recognition in terms of an environment to implement clinical trials from a global perspective, and uniform evaluation indicators need to be established for these items, etc. (refer to Attachment 2 "Working Group Investigation Results Regarding the Streamlining of Clinical Trials").例文帳に追加

特に、治験の効率化等についてはより詳細な検討を要することから「治験の効率化等 に関するワーキンググループ」を設置し、コスト、スピード、質の主要な3つの事項を中心に検討が行われ、これまでの関係者の取組みにより全体として着実な改善がみられたものの、我が国が治験を実施する環境として世界的な視点から一定の評価を得るためにはまだ解決すべき課題があること、及びそれらの事項について一定の評価指標を定める必要があること等の評価及び課題が示された（添付資料2 「治験の効率化等に関する ワーキンググループ検討結果」参照）。 - 厚生労働省

National efforts are also being taken in neighboring Asian countries. Implementation systems for clinical trials in the later stages of development have nearly been established, and furthermore, efforts are being made to develop implementation systems for clinical research at an early stage in the development process, as in the United States and Europe. There are thus increasing concerns that Japan must further accelerate and reinforce its efforts in order to survive the fierce global competition.例文帳に追加

また、近隣アジア諸国においても国をあげた取組みが進められ、開発後期の治験の実施体制がほぼ確立され、更に欧米と同じくより早期の開発段階の臨床研究の実施体制整備に取り組もうとしており、我が国の取組みを更に加速かつ充実させていかなければ厳しい国際競争に打ち勝てない懸念が強まっている。 - 厚生労働省

It has been pointed out that the GCP Ordinance requires more implementation documents than the global standard (ICH – GCP). In the interest of promoting efficient clinical trial administration and the conduct of multinational trials, the parties concerned are also seeking its rationalization insofar as matters such as the protection of trial subjects are not affected. With reference to this situation, discussion shall be held with a view to improving the implementation of the GCP Ordinance and facilitating the conduct of clinical trials. (Fiscal 2007)例文帳に追加

ＧＣＰ省令については、国際的な標準（ＩＣＨ－ＧＣＰ）と比較して、運用上多くの必須文書が求められている等の指摘があり、治験事務の効率化や国際共同治験の推進等の観点から被験者の保護等に支障がない範囲でその合理化を図ることが関係者からも望まれている。このような現状を踏まえ、ＧＣＰ省令の運用改善を行い、治験の円滑化が図られるよう検討することとしている。（2007 年度） - 厚生労働省