Ueda Rieko, Nishizaki Yuji, Nojiri Shuko, Iwata Hiroshi, Miyauchi Katsumi, Matsuyama Kotone, Sanada Shoji, Minamino Tohru, Daida Hiroyuki
Department of Cardiovascular Biology and Medicine, Juntendo University School of Medicine, Tokyo, Japan.
Medical Technology Innovation Center, Juntendo University, Tokyo, Japan.
Front Pharmacol. 2021 Oct 27;12:753067. doi: 10.3389/fphar.2021.753067. eCollection 2021.
Under-recruitment in clinical trials is an issue worldwide. If the number of patients enrolled is lower than expected, based on the required sample size, then the reliability of the study results and their validation tend to be impaired. The current study therefore evaluated factors associated with accelerating patient enrollment using data from an ongoing multicenter prospective cohort study. The researchers encouraged research institutions to accelerate patient enrollment e-mail, newsletters, telephone calls, and site visits. We analyzed the relationship between several potential factors associated with acceleration of patient enrollment including site visits and patient enrollment in a real clinical study. Data were collected from 106 research institutions that participated in a multicenter prospective cohort study. Results showed that the following parameters differed in terms of patient enrollment and non-enrollment: urban area (47.2 vs. 67.6%, = 0.04), clinical research coordinator (CRC) participation in data input to electronic data capture (EDC) (41.7 vs. 11.8%, < 0.01), and site visit (38.9 vs. 11.8%, < 0.01). A multivariate analysis revealed that patient enrollment was significantly associated with urban area (odds ratio [OR] 0.33, 95% confidence interval [CI] 0.12-0.86, = 0.02), CRC participation in data input to EDC (OR 5.02; 95% CI 1.49-16.8; < 0.01), and site visit (OR 4.54, 95% CI 1.31-15.7, = 0.01). In conclusion, site visits and CRC participation in data input to EDC had a significant effect on patient enrollment promotion. Moreover, hospitals in rural areas were more effective in promoting patient enrollment than those in urban areas.
临床试验中招募不足是一个全球性问题。如果入组患者数量低于基于所需样本量的预期，那么研究结果的可靠性及其验证往往会受到损害。因此，本研究利用一项正在进行的多中心前瞻性队列研究的数据，评估了与加速患者招募相关的因素。研究人员通过电子邮件、时事通讯、电话和实地考察等方式鼓励研究机构加速患者招募。我们分析了包括实地考察和实际临床研究中的患者招募等几个与加速患者招募相关的潜在因素之间的关系。数据收集自参与多中心前瞻性队列研究的106个研究机构。结果显示，以下参数在患者招募和未招募方面存在差异：城市地区（47.2%对67.6%，P = 0.04）、临床研究协调员（CRC）参与电子数据采集（EDC）的数据录入（41.7%对11.8%，P < 0.01）以及实地考察（38.9%对11.8%，P < 0.01）。多变量分析显示，患者招募与城市地区显著相关（优势比[OR] 0.33，95%置信区间[CI] 0.12 - 0.86，P = 0.02）、CRC参与EDC的数据录入（OR 5.02；95% CI 1.49 - 16.8；P < 0.01）以及实地考察（OR 4.54，95% CI 1.31 - 15.7，P = 0.01）。总之，实地考察和CRC参与EDC的数据录入对促进患者招募有显著影响。此外，农村地区的医院在促进患者招募方面比城市地区的医院更有效。
