Department of Drug Policy and Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan.
BMC Med Res Methodol. 2011 Nov 1;11:148. doi: 10.1186/1471-2288-11-148.
Large-scale clinical trials with thousands of participants are often needed to evaluate the risk reductions of cardiac events and/or death. Many recent clinical trials have evaluated the incidences of cardiac events using hard endpoints, especially in cardiovascular and metabolic medicine. A high investigation cost is involved in conducting a large-scale clinical trial, and obtaining sufficient funding is essential. The infrastructural environment of clinical trials is currently inadequate in Japan. We conducted a questionnaire-based survey to address this issue. The present study sought to clarify the current situation surrounding large-scale clinical trials in terms of funding and infrastructure, and to inform discussion about improving the financial and infrastructural situation for clinical trials.
We sent questionnaires to 119 sponsors of large-scale clinical trials between August 2007 and December 2007, and between July 2009 and August 2009. Answers to each question were summarized and data were statistically analyzed.
We received responses from the sponsors of 63 (52.9%) out of 119 trials to which questionnaires were sent. The results revealed that 25 trials (39.7%) were funded by foundations, and 21 trials (33.3%) were funded by public agencies. All of the foundations involved in conducting clinical trials, where funding sources were specified, were funded by private organizations such as pharmaceutical companies. All of the clinical trials with a cost of JPY 300 million (USD 3.27 million) or more were funded by private organizations, and none were funded solely by public agencies. The sponsors of 23 trials (36.5%) responded that the trial was 'not registered' to clinical trial registry.
The questionnaire responses revealed that there were still many trials whose funding sources were unclear and many sponsors were unaware of their responsibilities in managing and/or financing the costs of clinical trials. These findings indicate that further discussion is required to establish appropriate frameworks and/or rules regarding funding, while considering conflicts of interest. This discussion should take place as soon as possible to facilitate appropriate clinical trials.
为了评估心脏事件和/或死亡的风险降低，通常需要进行有数千名参与者的大规模临床试验。许多最近的临床试验使用硬终点评估心脏事件的发生率，特别是在心血管和代谢医学领域。进行大规模临床试验需要高昂的调查成本，获得足够的资金至关重要。日本目前的临床试验基础设施环境还不够完善。我们进行了一项基于问卷调查的调查来解决这个问题。本研究旨在阐明当前在资金和基础设施方面的大规模临床试验现状，并为改善临床试验的财务和基础设施状况提供信息。
我们于 2007 年 8 月至 12 月和 2009 年 7 月至 8 月期间向 119 个大规模临床试验的赞助商发送了问卷。对每个问题的回答进行了总结，并进行了统计分析。
我们收到了对 119 项试验中 63 项（52.9%）试验的赞助商的回复。结果表明，25 项试验（39.7%）由基金会资助，21 项试验（33.3%）由公共机构资助。所有参与临床试验的基金会，如果指定了资金来源，则全部由制药公司等私营组织资助。所有成本达到 3 亿日元（3270 万美元）或以上的临床试验均由私营组织资助，没有一个是完全由公共机构资助的。23 项试验的赞助商（36.5%）回应称该试验“未注册”临床试验登记处。
问卷回复显示，仍有许多试验的资金来源不清楚，许多赞助商不知道自己在管理和/或资助临床试验成本方面的责任。这些发现表明，需要进一步讨论建立适当的框架和/或规则，考虑利益冲突。为了促进适当的临床试验，应尽快进行此类讨论。
