Drug Evaluation Committee Report on the Analysis of the Current Status of Clinical Trial Networks and the Results of Studies Toward Their Future Development
Clinical Evaluation Subcommittee
August 2017
In TF1 of the Clinical Evaluation Subcommittee in FY2016, we conducted a questionnaire survey of both clinical trial NWs and sponsors to analyze the current status of clinical trial NWs, their functions, and what is expected of them. We also examined how clinical trial NWs should be promoted by sponsors, and summarized what each clinical trial NW should focus on and what clinical trial NWs as a whole should work on.
We hope that this report will help the proactive activation activities of clinical trial NWs and lead to the further development of clinical trial NWs and the revitalization of clinical trials in Japan.
Attachment 1
We have compiled the results of a questionnaire survey received from 35 nationwide networks ("medical NWs") formed under the initiative of universities, medical associations, medical corporations, independent administrative agencies, and others between September 2016 and December 2016. The survey results are categorized into eight items: (1) basic information, (2) improvement of case accumulation, (3) streamlining of clinical trial procedures, (4) human resource development and recruitment, (5) public and patient awareness, (6) cost optimization, (7) use of IT technology, and (8) characteristics and issues of clinical trial NWs. In addition to the results of the survey, we have also compiled the contents of the questionnaire as Appendix 1 for reference.
Attachment 2
Based on the interview survey conducted with NWs, specific measures (clinical trial progress management by the NW secretariat, utilization of intra-institutional information (receipt data), and establishment and operation of a voluntary patient transfer model for participation in clinical trials) that could be proactively taken by NWs to further improve case accumulation are proposed. (management of clinical trial progress by the clinical trial NW office, utilization of intra-institutional information (receipt data), and construction and operation of a voluntary patient movement model for clinical trial participation). We hope that the proposal in Attachment 2 will be referred to by many clinical trial networks and will serve as a foothold to promote cross-sectional studies among clinical trial networks, medical institutions, and sponsors in the future.
Attachment 2: Study on Further Measures to Improve Case Concentration (565KB)
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