Akaza Hideyuki, Fukuoka Masahiro, Ohtsu Atsushi, Usami Michiyuki, Ikeda Tadashi, Aiba Keisuke, Isonishi Seiji, Ohashi Yasuo, Saijo Nagahiro, Sone Saburo, Tsukagoshi Shigeru, Tsuruo Takashi, Kato Masuhiro, Mikami Osamu, Dong Rui-Ping, von Euler Mikael, Blackledge George, Stribling Don
Dept. of Urology, Institute of Clinical Medicine, University of Tsukuba.
Gan To Kagaku Ryoho. 2003 Apr;30(4):555-65.
Based on reviews of the Japanese clinical trial situation in lung cancer, gastric cancer, prostate cancer and breast cancer, it was clear that much progress has been made in short time. There are considerable differences between Japan and the West and also differences between clinical areas in Japan. For regulatory purposes bridging studies have become increasingly important. Use of identical protocols are required for effective bridging. Participations in global phase III trials is the best way of achieving registration in Japan. For successful global trials in Japan it is important to include Japanese investigators in the preparation of the protocol and to recognise the challenges facing such a project. Clinical practice in diagnosis and treatment have many differences, thus it is recommended to have clear and detailed information in the protocol. Hard end points like survival are important since they are not biased by cultural differences. There are clear difficulties with HE or QOL outcomes. The emergence of focus on evidence based medicine is also happening in Japan and will help to harmonize documentation across the world. For large adjuvant or prevention cancer global trials are essential. To facilitate global studies further development of infrastructure is necessary in Japan. Use of electronic data capture web based communication etc. will help overcome communication difficulties. Other improvements that will make Japanese participation in global trials easier and better include establishment of clinical trial centre at each hospital, introduction of trial coordinators or study nurses and an improved collaboration with company staff. A critical issue that also need addressing is agreement of centre target recruitment. We need to introduce a new flexible system in Japan if participation in global trial is to be optimised. If we can address these issues Japanese investigators and collaborative groups should be able to initiate and lead global trials in the future.
基于对日本肺癌、胃癌、前列腺癌和乳腺癌临床试验情况的审查，很明显在短时间内已经取得了很大进展。日本与西方之间存在相当大的差异，日本国内不同临床领域之间也存在差异。出于监管目的，桥接研究变得越来越重要。为了进行有效的桥接，需要使用相同的方案。参与全球III期试验是在日本获得注册的最佳方式。要在日本成功开展全球试验，重要的是在方案制定过程中纳入日本研究人员，并认识到此类项目面临的挑战。诊断和治疗方面的临床实践存在许多差异，因此建议在方案中提供清晰详细的信息。像生存率这样的硬终点很重要，因为它们不受文化差异的影响。在硬终点或生活质量结果方面存在明显困难。日本也出现了对循证医学的关注，这将有助于统一全球的文献记录。对于大型辅助或预防癌症试验，全球试验至关重要。为了促进全球研究，日本需要进一步发展基础设施。使用基于网络的电子数据采集、通信等将有助于克服沟通困难。其他有助于日本更轻松、更好地参与全球试验的改进措施包括在每家医院设立临床试验中心、引入试验协调员或研究护士以及改善与公司工作人员的合作。另一个需要解决的关键问题是中心目标招募的一致性。如果要优化日本参与全球试验的情况，我们需要在日本引入一种新的灵活系统。如果我们能够解决这些问题，日本研究人员和合作团体未来应该能够发起并引领全球试验。
