Centers for Disease Control and Prevention, Atlanta, GA, USA.
Northrop Grumman, Atlanta, GA, USA.
Clin Trials. 2020 Feb;17(1):39-51. doi: 10.1177/1740774519885380. Epub 2019 Nov 6.
BACKGROUND/AIMS: Efficient recruitment of eligible participants, optimizing time and sample size, is a crucial component in conducting a successful clinical trial. Inefficient participant recruitment can impede study progress, consume staff time and resources, and limit quality and generalizability or the power to assess outcomes. Recruitment for disease prevention trials poses additional challenges because patients are asymptomatic. We evaluated candidates for a disease prevention trial to determine reasons for nonparticipation and to identify factors that can be addressed to improve recruitment efficiency.
During 2001-2009, the Tuberculosis Trials Consortium conducted Study 26 (PREVENT TB), a randomized clinical trial at 26 sites in four countries, among persons with latent tuberculosis infection at high risk for tuberculosis disease progression, comparing 3 months of directly observed once-weekly rifapentine plus isoniazid with 9 months of self-administered daily isoniazid. During March 2005-February 2008, non-identifying demographic information, risk factors for experiencing active tuberculosis disease, and reasons for not enrolling were collected from screened patients to facilitate interpretation of trial data, to meet Consolidated Standards of Reporting Trials standards, and to evaluate reasons for nonparticipation.
Of the 7452 candidates screened in Brazil, Canada, Spain, and the United States, 3584 (48%) were not enrolled, because of ineligibility (41%), site decision (10%), or patient choice (49%). Among those who did not enroll by own choice, and for whom responses were recorded on whether they would accept treatment outside of the study (n = 1430), 68% reported that they planned to accept non-study latent tuberculosis infection treatment. Among 1305 patients with one or more reported reasons for nonparticipation, study staff recorded a total of 1886 individual reasons (reason count: median = 1/patient; range = 1-9) for why patients chose not to enroll, including grouped concerns about research (24% of 1886), work or school conflicts (20%), medication or health beliefs (16%), latent tuberculosis infection beliefs (11%), and patient lifestyle and family concerns (10%).
Educational efforts addressing clinical research concerns and beliefs about medication and health, as well as study protocols that accommodate patient-related concerns (e.g. work, school, and lifestyle) might increase willingness to enter clinical trials. Findings from this evaluation can support development of communication and education materials for clinical trial sites at the beginning of a trial to allow study staff to address potential participant concerns during study screening.
背景/目的：高效招募符合条件的参与者，优化时间和样本量，是成功开展临床试验的关键组成部分。低效的参与者招募会阻碍研究进展，消耗工作人员的时间和资源，并限制研究质量、推广性或评估结果的能力。预防疾病的临床试验的招募工作面临着额外的挑战，因为患者没有症状。我们评估了预防疾病试验的候选人，以确定不参与的原因，并确定可以解决哪些因素以提高招募效率。
在 2001 年至 2009 年期间，结核病试验联合会（Tuberculosis Trials Consortium）在四个国家的 26 个地点开展了研究 26（预防结核），对处于结核病进展高风险的潜伏性结核感染者进行了一项随机临床试验，比较了 3 个月直接观察每周一次利福喷丁加异烟肼与 9 个月自行每日服用异烟肼的疗效。在 2005 年 3 月至 2008 年 2 月期间，从筛选出的患者中收集了非识别人口统计学信息、发生活动性结核病的风险因素和不参与的原因，以促进对试验数据的解释、满足临床试验报告的统一标准，并评估不参与的原因。
在巴西、加拿大、西班牙和美国筛查的 7452 名候选人中，有 3584 名（48%）因不符合条件（41%）、地点决定（10%）或患者选择（49%）而未被纳入。在那些因自身选择而不参与，且记录了他们是否会接受研究以外的治疗的人中（n=1430），有 68%的人表示他们计划接受非研究性潜伏性结核感染治疗。在 1305 名有一个或多个不参与原因的患者中，研究人员共记录了 1886 个患者选择不参与的个人原因（原因数：中位数=1/患者；范围=1-9），包括对研究的担忧（24%的 1886 个原因）、工作或学校冲突（20%）、药物或健康信念（16%）、潜伏性结核感染信念（11%）以及患者生活方式和家庭问题（10%）。
针对药物和健康方面的临床研究关注和信念的教育工作，以及适应患者相关问题的研究方案（如工作、学校和生活方式），可能会提高参与临床试验的意愿。这项评估的结果可以为临床试验开始时的临床试验地点的沟通和教育材料的开发提供支持，以便研究人员在研究筛选期间解决潜在的参与者问题。
