Clinical trial implementation and recruitment: lessons learned from the early closure of a randomized clinical trial.
Clinical trial implementation and recruitment: lessons learned from the early closure of a randomized clinical trial.
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DOI：
10.1016/j.cct.2011.11.018
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发表时间：
2012-03
影响因子：
2.2
通讯作者：
Sickle Cell Disease Clinical Research Network (SCDCRN)
中科院分区：
文献类型：
--
作者：
Peters-Lawrence MH;Bell MC;Hsu LL;Osunkwo I;Seaman P;Blackwood M;Guillaume E;Bellevue R;Krishnamurti L;Smith WR;Dampier CD;Minniti CP;Sickle Cell Disease Clinical Research Network (SCDCRN)
nhlbi赞助的镰状细胞病临床研究网络（SCDCRN）进行了一项多中心、急性干预的随机临床试验，研究了两种患者自控镇痛治疗急性疼痛的方法。由于低入组率，该试验被提前终止。我们分析了协调员和主要研究者报告的感知障碍和招聘困难。参与站点完成了在整个研究过程中承认有疼痛危机的受试者的缺失资格日志，并在试验结束时进行了调查。该调查涵盖了研究实施中的具体因素、政策和程序、招聘策略和资格因素。新英格兰研究机构（NERI）从31个参与网站中的29个收集了31名受访者的去身份调查。从2009年12月到2010年6月，参与研究的机构中发生了1116例SCD和疼痛患者：38名受试者入组（14名儿童和24名成人），34名受试者完成了试验，低于预期的278名受试者。14个站点登记了受试者，17个站点没有登记。招募障碍包括人员不足、受试者不合格或太痛苦而无法同意、相互竞争的方案以及对疼痛控制的担忧。招募方法是从紧急护理、SCD诊所和内部数据库转诊。没有使用媒体或外部医生的报道。我们发现了患者累积的多重障碍，包括入组时间短、方案设计、复杂的给药计划、周末和下班后对工作人员的要求、多个部门的参与、方案的可接受性、资格标准、相互竞争的方案和有限的工作人员。这些领域中的每一个都应该成为干预的目标，以便计划和开展成功的未来临床试验。
The NHLBI-sponsored Sickle Cell Disease Clinical Research Network (SCDCRN) conducted a multi-center, acute intervention randomized clinical trial of two methods of Patient Controlled Analgesia for acute pain. This trial was terminated early due to low enrollment. We analyzed the perceived barriers and recruitment difficulties as reported by the coordinators and principal investigators. Participating sites completed a missed eligibility log of subjects admitted in pain crisis throughout the study and a survey at the end of the trial. The survey covered site-specific factors, policies, and procedures in study implementation, recruitment strategies, and eligibility factors. The New England Research Institutes (NERI) collected de-identified surveys from 31 respondents at 29 of 31 participating sites. From December 2009 to June 2010, 1116 patient encounters for SCD and pain occurred at participating institutions: 38 subjects were enrolled (14 pediatric and 24 adults) and 34 completed the trial, below the projected 278 subjects. Fourteen sites enrolled subjects and seventeen did not. Recruitment barriers included insufficient staff, subject ineligibility or in too much pain to consent, competing protocols, and concerns regarding pain control. Recruitment methods were referrals from urgent care, SCD clinics and in house databases. No use of media or outside physicians was reported. We identified multiple barriers to patient accrual including short duration of enrollment period, protocol design, complex dosing schedule, requirement for staff availability during week-end and after hours, multiple departments’ involvement, protocol acceptance, eligibility criteria, competing protocols, and limited staff. Each of these areas should be targeted for intervention in order to plan and conduct successful future clinical trials.
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DOI：
10.1016/j.jana.2010.10.008
发表时间：
2011-09
影响因子：
2
作者：
Polanco, Frinny R.;Dominguez, Dinora C.;Grady, Christine;Stoll, Pamela;Ramos, Catalina;Mican, JoAnn M.;Miranda-Acevedo, Robert;Morgan, Marcela;Aizvera, Jeasmine;Purdie, Lori;Koziol, Deloris;Rivera-Goba, Migdalia V.
通讯作者：
Rivera-Goba, Migdalia V.
影响因子：
3.1
作者：
Robinson, JaMuir M.;Trochim, William M. K.
通讯作者：
Trochim, William M. K.
影响因子：
158.5
作者：
PLATT, OS;THORINGTON, BD;KINNEY, TR
通讯作者：
KINNEY, TR
影响因子：
2.7
作者：
Schroen, Anneke T.;Petroni, Gina R.;Djulbegovic, Benjamin
通讯作者：
Djulbegovic, Benjamin
影响因子：
120.7
作者：
Gladwin, Mark T.;Kato, Gregory J.;Casella, James F.
通讯作者：
Casella, James F.