Wood Dallas, Kosa Katherine, Brown Derek, Ehrlich Orna G, Higgins Peter D R, Heller Caren
RTI International, Research Triangle Park, NC.
George Warren Brown School of Social Work, Washington University, St. Louis, MO.
Crohns Colitis 360. 2019 Nov 28;2(1):otz048. doi: 10.1093/crocol/otz048. eCollection 2020 Jan.
Clinical trial recruitment is the rate-limiting step in developing new treatments. To understand inflammatory bowel disease (IBD) patient recruitment, we investigated two questions: Do changes in clinical trial attributes, like monetary compensation, influence recruitment rates, and does this influence differ across subgroups?
We answered these questions through a conjoint survey of 949 adult IBD patients.
Recruitment rates are influenced by trial attributes: small but significant increases are predicted with lower placebo rates, reduced number of endoscopies, less time commitment, open label extension, and increased involvement of participant's primary GI physician. A much stronger effect was found with increased monetary compensation. Latent class analysis indicated three patient subgroups: some patients quite willing to participate in IBD trials, some quite reluctant, and others who can be persuaded. The persuadable group is quite sensitive to monetary compensation, and payments up to US$2,000 for a 1-year study could significantly increase recruitment rates for IBD clinical trials.
This innovative study provides researchers with a framework for predicting recruitment rates for different IBD clinical trials.
临床试验招募是开发新疗法的限速步骤。为了解炎症性肠病（IBD）患者的招募情况，我们调查了两个问题：临床试验属性的变化，如金钱补偿，是否会影响招募率，以及这种影响在不同亚组中是否存在差异？
我们通过对949名成年IBD患者进行联合调查来回答这些问题。
招募率受试验属性影响：预计安慰剂率降低、内镜检查次数减少、时间投入减少、开放标签扩展以及参与者的初级胃肠科医生参与度提高会带来虽小但显著的增加。金钱补偿增加则会产生更强的效果。潜在类别分析表明存在三个患者亚组：一些患者非常愿意参与IBD试验，一些患者非常不愿意，还有一些患者可以被说服。可说服组对金钱补偿非常敏感，对于为期1年的研究，支付高达2000美元的费用可显著提高IBD临床试验的招募率。
这项创新性研究为研究人员提供了一个预测不同IBD临床试验招募率的框架。
