リモート SDV による治験効率化の実態と今後への期待

山谷 明正, 井上 和紀, 望月 恭子, 森 奈海子, 笹浪 和秀, 肥田木 康彦, 安永 昇司, 北川 雅一, 榎本 有希子, 氏原 淳

doi:10.3999/jscpt.44.47

Background: We conducted a questionnaire survey on clinical research associates (CRAs) of pharmaceutical companies and contract research organizations (CROs) to investigate the current status of using remote source data verification (SDV) in Japan, and to evaluate the problems related to remote SDV. Methods: The survey was performed using a self-administered questionnaire posed on the web site for CRAs in Japan. The questionnaire survey was carried out from 11 to 25 October 2011. Results: There were 640 responses from CRAs. Sixty-four percent of all respondents knew about remote SDV, and 33 CRAs had experienced using remote SDV. Regarding the possibility of using remote SDV in on-the-job training (OJT), 82% of inexperienced CRAs and 76% of experienced CRA responded “possible”. In terms of the expectation of remote SDV, 91% of experienced CRAs and 86% of inexperienced CRAs responded that they would like to use remote SDV. Although the expectation is high, 76% of CRAs responded that the standard operating procedure (SOP) describing the use of remote SDV was not available in their companies or CROs. The interval of site visit had extended significantly in sites implementing remote SDV compared with visits made by inexperienced CRAs in sites implementing standard SDV (p<0.001). Conclusions: The present survey showed that although remote SDV has not yet been widely implemented, there is high expectation of using remote SDV among the CRAs.The result also suggested that using remote SDV might decrease the time spent onsite and the frequency of onsite visits. The survey also showed that SOP for remote SDV is not available in many pharmaceutical companies and CROs. Guidelines and SOPs have to be established in the near future. (Jpn J Clin Pharmacol Ther 2013; 44(1): 47-52)

<b>リモート SDV による治験効率化の実態と今後への期待</b>

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