Web-based trial to evaluate the efficacy and safety of tolterodine ER 4 mg in participants with overactive bladder: REMOTE trial
Web-based trial to evaluate the efficacy and safety of tolterodine ER 4 mg in participants with overactive bladder: REMOTE trial
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DOI：
10.1016/j.cct.2014.04.009
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发表时间：
2014-07-01
影响因子：
2.2
通讯作者：
Cummings, Steven R.
中科院分区：
文献类型：
--
作者：
Orri, Miguel;Lipset, Craig H.;Cummings, Steven R.
引言：以患者为中心的、基于网络的方法可以简化和提高临床试验参与的便利性。我们使用了一个完全基于网络的方法进行随机，安慰剂对照，4期（远程）试验下的新药研究（IND）的应用，以评估托特罗定延长释放（ER）4毫克膀胱过度活动症。方法：该试验的目的是复制以前的临床试验托特罗定ER，但通过网络进行从一个临床网站监督的医生。参与者通过网络招募，使用基于网络的问卷筛选资格，在其社区进行实验室测试，并进入需要膀胱电子日记的磨合阶段。知情同意书是通过基于网络的交互式方法获得的，并由医生会签。研究药物直接运送给参与者。结果：目标为283名随机参与者，5157名在试验网站上注册。在456名通过初始筛选、身份验证和签署知情同意书的受试者中，237名通过额外的医学筛选并由研究者会签。实验室检测后，118人进入安慰剂导入期;只有18人通过电子日志评估并随机接受治疗。在第12周，托特罗定ER组排尿次数/24小时（主要终点）相对于基线的平均变化为-2.4，安慰剂组为-0.8 [治疗差异（95%CI）：1.6（-3.9，0.6）]。观察到的疗效与常规试验的结果一致。随着多步骤筛选和测试的简化，基于网络的试验或其组成部分应该为许多临床试验提供参与者友好的方法。(C)2014 Elsevier Inc. All rights reserved.
Introduction: Participatory patient-centered, web-based methods could streamline and improve the convenience of clinical trial participation. We used an entirely web-based approach to conduct a randomized, placebo-controlled, Phase 4 (REMOTE) trial under an Investigational New Drug (IND) application to evaluate tolterodine extended release (ER) 4 mg for overactive bladder.Methods: The trial was designed to replicate previous clinic-based trials of tolterodine ER but was conducted via the web from one clinical site overseen by physicians. Participants were recruited via the web, screened for eligibility using web-based questionnaires, had laboratory testing in their community, and entered a run-in phase requiring bladder e-diaries. Informed consent was obtained using an interactive web-based method with physician countersignature. Study medication was shipped directly to participants.Results: With a goal of 283 randomized participants, 5157 registered on the trial website. Of 456 who passed initial screening, identification verification, and signed consent, 237 passed additional medical screening and were countersigned by the investigator. After laboratory testing, 118 entered the placebo run-in; only 18 passed e-diary assessments and were randomized to treatment. At week 12, the mean change from the baseline in micturitions/24 hours (primary endpoint) was -2.4 for tolterodine ER versus -0.8 for placebo [treatment difference (95% CI): 1.6 (-3.9, 0.6)].Conclusion: The REMOTE trial is the first entirely web-based trial conducted under an IND application. The efficacy observed was consistent with results from conventional trials. With simplification of multi-step screening and testing, web-based trials or their component parts should provide a participant-friendly approach to many clinical trials. (C) 2014 Elsevier Inc. All rights reserved.