Participation in and withdrawal from cancer clinical trials: A survey of clinical research coordinators.

ABSTRACT

Objective: Poor accrual and withdrawal are the main reasons for the failure of cancer clinical trials. As clinical research coordinators (CRCs) work at the frontlines of clinical trials, CRCs can best identify the main factors that influence patient participation and dropout and suggest potential remedial measures. This study aimed to investigate participation and withdrawal in cancer clinical trials through a survey of CRCs. Furthermore, we collected suggestions of CRCs to increase patient participation and reduce withdrawal from cancer clinical trials. Methods: This cross-sectional survey among 100 CRC nurses currently coordinating cancer clinical trials and having more than six months of experience was conducted at four hospitals in South Korea between March and August 2021. We designed a questionnaire based on prior studies, and the key items included characteristics of respondents, characteristics of clinical trials, clinical trial participation, and withdrawal. Results: Patients refused to participate due to concern about adverse events (46.5%) and negative perception of clinical trials (44.4%). The main reasons for study withdrawal were disease progression (71.5%), adverse events (10.6%), and withdrawal of consent due to personal issues (5.5%). The provision of sufficient explanation was suggested as a remedial measure for increasing consent to participate (67.4%) and reducing withdrawal (21.8%). Conclusions: A survey of CRCs revealed the reasons governing patient participation and withdrawal in cancer clinical trials, thereby providing a novel insight into strategies for promoting subject enrollment and reducing withdrawal from cancer clinical trials.