Drug Evaluation Committee Report on Examination of Efficient Feasibility Study Methodology
Clinical Evaluation Subcommittee
June 2016
In TF-1 of the Clinical Evaluation Committee in FY2015, we examined how to achieve an efficient feasibility study by unraveling the "feasibility study" conducted by the sponsor prior to the start of a clinical trial and organizing it according to the purpose of the study, rather than lumping all feasibility studies into one category. The following report and appendices summarize the results of this study.
- Report: Report on the Study of Efficient Feasibility Study Methods
- Attachment 1: Survey Questionnaire for Clinical Trial Protocol Preparation
- Attachment 2: Checklist of Points to Consider When Conducting Feasibility Study
- Attachment 3: Questionnaire Survey on the Utilization of Public Information of Medical Institutions
- Attachment 4: Results of Analysis of "Information Database of Medical Institutions Conducting Clinical Trials" by Center for Promoting Clinical Trials of the Japan Medical Association
- Attachment 5: Questionnaire Survey on the List of Useful Information for Clinical Trial Sponsors
We hope that this report will help not only sponsors and medical institutions but also all parties involved in clinical trials to understand efficient feasibility studies and lead to good progress of clinical trials, success of clinical trials, and revitalization of clinical trials in Japan.
- Report】Report on the Study of Efficient Feasibility Study Methods (8.92MB)
- Attachment 1: Questionnaire Survey for Preparation of Clinical Trial Protocols (181KB)
- Attachment 2] Checklist of Points to Consider When Conducting a Survey for Preparation of a Clinical Trial Protocol (36KB)
- Attachment 3] Questionnaire on the use of public information on medical institutions (50KB)
- Attachment 4] Results of analysis of the Center for Promoting Clinical Trials, Japan Medical Association, "Database of Information on Clinical Trials Conducted by Medical Institutions" (47KB)
- Attachment 5] Questionnaire survey on consideration of the list of useful information for sponsors (98KB)
Deliverables of the Drug Evaluation Committee Return to list of all deliverables