Consideration of the Implementation of Direct to Patient Approach in Clinical Trials in Japan Based on Questionnaire Survey

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  • 治験協力者へのアンケート調査にもとづく本邦における治験薬の被験者宅への輸送に関する課題の抽出
  • チケンキョウリョクシャ エ ノ アンケート チョウサ ニ モトズク ホンポウ ニ オケル チケンヤク ノ ヒケンシャタク エ ノ ユソウ ニ カンスル カダイ ノ チュウシュツ

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Abstract

<p>A new style of clinical trials, called Decentralized Clinical Trials, enables patients to participate in clinical trials with low-frequency visits or without having to visit a site by utilizing new methodologies such as Site to Patient, which entails delivering investigational products (IPs) to a patient from the site and Depot to Patient approach, in which IPs are shipped to the patient’s home directly from the depot without a need for the site. Based on a questionnaire-based survey that we conducted on clinical trial staff with the Academic Research Organization (ARO) Council, we observed the changes in workload associated with the introduction of Depot to Patient and its acceptability, the experience of Site to Patient in clinical trials conducted under the COVID-19 outbreak, and the results of online administration guidance when Site to Patient was conducted. The respondents expected that the introduction of the Depot to Patient approach would reduce their workload, but identified issues such as responsibility and involvement in the selection of vendors as challenges. In addition, even under the COVID-19 outbreak, the experience of Site to Patient was limited, and the staff who had the experience of Site to Patient approach felt an increased workload. Many investigational product administrators answered negatively about the implementation of non-face-to-face drug administration guidance when using Site to Patient approach. Now that the Pharmaceutical and Medical Device Act has been revised to allow online drug administration guidance, it is hoped that the experience and knowledge accumulated will be utilized for non-face-to-face drug administration guidance during Site to Patient or Depot to Patient approach implementation.</p>

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