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Background: Medical devices are continuously being improved in routine clinical practice. As necessary, new or additional clinical data for an investigational medical device is collected through clinical research and/or registered clinical investigations. We conducted a questionnaire survey to determine the current environment for clinical research with medical devices, particularly focusing on infrastructure and human resources in hospitals.
Methods: The questionnaire for this study included 6 main topics: experience of clinical research, in-hospital manuals, issues on clinical research, related regulations, and effectiveness of a guidance published by the Medical Engineering Technology Industrial Strategy Consortium. The questionnaire was mailed to all 10 core clinical research centers and 30 major clinical trial institutions at the time of survey in Japan.
Results: Eighteen hospitals (45%) provided responses. Relatively few clinical research activities with medical devices had been conducted in each hospital, and two-thirds of respondents thought low number of clinical research activities was problematic. A shortage of experts in medical devices was also raised as an important challenge. Most of the hospitals had established in-hospital manuals for clinical research with medical devices; however, specific features required for the evaluation of medical devices might not be included in the manuals. Many hospitals had too few clinical research coordinators
(CRCs) for support of clinical research with medical devices, but half of the hospitals could not afford to increase the number of CRCs.
Conclusion: Our study revealed that the current environment for clinical research with medical devices in hospitals has been partly organized, but it was suggested that a shortage of experts, the complexity of the regulatory system, and a need for financial support are remaining issues.