臨床研究コーディネーターが治験における被験者ケアにおいて抱える課題の抽出：フォーカスグループインタビュー法を用いた研究

抄録

The role of a clinical research coordinator (CRC) is to support and facilitate clinical research activities, and thus the CRC plays a key role in conducting clinical research. Care for participants during the trial is a particularly important aspect of the CRC's responsibilities, but the difficulties and challenges involved remain unclear. This study aimed to clarify the issues related to care for participants from the perspective of CRCs by means of semi-structured focus-group interviews. The issues were extracted from verbatim data of the interviews by coding and categorization based on the KJ method. Sixteen CRCs participated in the study. There were 4 categories of issues; CRCs themselves, related to participants, doctors, and the environment. “Difficulty in interacting with participants” or “difficulty of explaining the trial to participants” were perceived as issues of CRCs themselves, and “participants' high expectations” or “participants' misunderstanding of clinical trials” were identified as issues of participants. In addition, “insufficient communication between participant and doctor”, “ambiguity in the division of roles between doctor and CRC”, and “differences in the expertise of CRCs such as nurses and pharmacists” were perceived as issues that affect care for participants. For CRCs, to efficiently fulfill their responsibilities, it would be necessary to resolve the multifaceted issues related to care for participants identified in this study.