Questionnaire Analysis on the Use of Foreign Clinical Trials in Domestic Drug Development
Kuniaki Yasuda (Senior Researcher, Pharmaceutical and Industrial Policy Research Institute)
Shunsuke Ono (Associate Professor, Department of Drug Evaluation Science, Graduate School of Pharmaceutical Sciences, The University of Tokyo)
Hiroe Kinoshita (Department of Drug Evaluation Science, Graduate School of Pharmaceutical Sciences, The University of Tokyo (Master's Program))
(No.39: Published in June 2008)
The decision-making process on the part of companies regarding the use of foreign clinical trials in domestic drug development, and the factors that companies consider when using foreign clinical trials and the importance of factors that companies perceive regulatory authorities consider when accepting foreign clinical trials, changes between 2000 and 2006 and the time of the survey (January 2008) The changes between 2000-2006 and the time of the survey (January 2008), as well as the differences in the importance placed by companies and regulators, were analyzed using a questionnaire.
According to the perceptions of companies from 2000 to 2006, in addition to the characteristics of the drug application, factors such as the quantity and quality of clinical trials comprising the clinical data package, racial differences, and the track record of approval in other countries were also important in the decision-making process of companies and regulatory authorities regarding the use and acceptance of foreign clinical trials. In addition, the perception at the time of the survey (January 2008) is that there is an increasing tendency to place importance on past approval cases and results, and companies are considering the use of foreign clinical trials while being aware of the actions of regulatory authorities as well as the development trends of other companies and other drugs. As a whole, responding firms place less emphasis on mid- to long-term economic factors (e.g., post-launch sales projections). However, foreign-affiliated companies are more likely than domestic companies to adopt development and application strategies that take this into account. In a situation where global drug development is becoming the norm, it is necessary to recognize that factors not directly addressed in current guidelines, etc. (e.g., economic factors such as new drug development costs and post-launch domestic market) are deeply involved in the construction of clinical data packages for new drugs. It is desirable to make progress in examining the use of foreign clinical trials as a method of domestic drug development that fully takes into account the impact on the health of the Japanese people.