Abstract
BackgroundLarge-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.MethodsWe 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.ResultsWe 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.ConclusionsThe 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.
Highlights
Large-scale clinical trials with thousands of participants are often needed to evaluate the risk reductions of cardiac events and/or death
After the Japanese Acute Myocardial Infarction Prospective (JAMP) study, we found a number of issues surrounding large-scale clinical trials [4]
Party responsible for monitoring and data management activities, and involvement of third-party Regarding the infrastructure required for conducting large-scale clinical trials, we investigated the situations surrounding the support of human resources and material resources in trials whose sponsors reported foundations or private organizations as funding sources
Summary
Large-scale clinical trials with thousands of participants are often needed to evaluate the risk reductions of cardiac events and/or death. 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. 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. In the 1970s, researchers began to conduct large-scale clinical trials in Western countries, with the incidence of cardiovascular events as endpoints [1,2]. The Japanese Acute Myocardial Infarction Prospective (JAMP) study [3] was the first non-pharmaceutical company-funded multicenter trial of a medication in Japan. After the JAMP study, we found a number of issues surrounding large-scale clinical trials [4]. No comprehensive regulations are currently in place to manage conflicts of interest in Japan
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