Department of Drug Policy and Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan.
Trials. 2011 Apr 14;12:96. doi: 10.1186/1745-6215-12-96.
Clinical evidence is important for improving the treatment of patients by health care providers. In the study of cardiovascular diseases, large-scale clinical trials involving thousands of participants are required to evaluate the risks of cardiac events and/or death. The problems encountered in conducting the Japanese Acute Myocardial Infarction Prospective (JAMP) study highlighted the difficulties involved in obtaining the financial and infrastructural resources necessary for conducting large-scale clinical trials. The objectives of the current study were: 1) to clarify the current funding and infrastructural environment surrounding large-scale clinical trials in cardiovascular and metabolic diseases in Japan, and 2) to find ways to improve the environment surrounding clinical trials in Japan more generally.
We examined clinical trials examining cardiovascular diseases that evaluated true endpoints and involved 300 or more participants using Pub-Med, Ichushi (by the Japan Medical Abstracts Society, a non-profit organization), websites of related medical societies, the University Hospital Medical Information Network (UMIN) Clinical Trials Registry, and clinicaltrials.gov at three points in time: 30 November, 2004, 25 February, 2007 and 25 July, 2009.
We found a total of 152 trials that met our criteria for 'large-scale clinical trials' examining cardiovascular diseases in Japan. Of these, 72.4% were randomized controlled trials (RCTs). Of 152 trials, 9.2% of the trials examined more than 10,000 participants, and 42.8% examined between 1,000 and 10,000 participants. The number of large-scale clinical trials markedly increased from 2001 to 2004, but suddenly decreased in 2007, then began to increase again. Ischemic heart disease (39.5%) was the most common target disease. Most of the larger-scale trials were funded by private organizations such as pharmaceutical companies. The designs and results of 13 trials were not disclosed.
To improve the quality of clinical trials, all sponsors should register trials and disclose the funding sources before the enrolment of participants, and publish their results after the completion of each study.
临床证据对于提高医疗保健提供者对患者的治疗水平非常重要。在心血管疾病的研究中，需要进行涉及数千名参与者的大规模临床试验，以评估心脏事件和/或死亡的风险。在进行日本急性心肌梗死前瞻性（JAMP）研究时遇到的问题突显了获得进行大规模临床试验所需的财务和基础设施资源的困难。本研究的目的是：1）阐明日本心血管和代谢疾病大规模临床试验的当前资金和基础设施环境，2）找到更普遍改善日本临床试验环境的方法。
我们使用 Pub-Med、Ichushi（由非营利组织日本医学摘要协会运营）、相关医学协会的网站、大学医院医疗信息网络（UMIN）临床试验注册处和 clinicaltrials.gov，在三个时间点检查了评估真实终点且涉及 300 名或更多参与者的心血管疾病临床试验：2004 年 11 月 30 日、2007 年 2 月 25 日和 2009 年 7 月 25 日。
我们共发现了 152 项符合我们在日本进行“大规模临床试验”标准的心血管疾病研究。其中，72.4%为随机对照试验（RCT）。在 152 项试验中，9.2%的试验检查了超过 10000 名参与者，42.8%的试验检查了 1000 至 10000 名参与者。从 2001 年到 2004 年，大规模临床试验的数量明显增加，但在 2007 年突然减少，然后再次开始增加。缺血性心脏病（39.5%）是最常见的目标疾病。大多数较大规模的试验都是由制药公司等私营组织资助的。有 13 项试验的设计和结果未公开。
为了提高临床试验的质量，所有赞助商应在招募参与者之前注册试验并披露资金来源，并在每项研究完成后公布结果。
