Challenges to accrual predictions to phase III cancer clinical trials: a survey of study chairs and lead statisticians of 248 NCI-sponsored trials
Challenges to accrual predictions to phase III cancer clinical trials: a survey of study chairs and lead statisticians of 248 NCI-sponsored trials
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DOI：
10.1177/1740774511419683
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发表时间：
2011-10-01
期刊：
影响因子：
2.7
通讯作者：
Djulbegovic, Benjamin
中科院分区：
文献类型：
--
作者：
Schroen, Anneke T.;Petroni, Gina R.;Djulbegovic, Benjamin
背景：关于累积障碍的研究通常强调试验启动后影响参与的因素。目的：我们试图找出影响试验设计和应计预测的因素之前，试验激活与足够accustry.Methods一个30个问题的基于网络的调查被发送到研究主席和首席统计师的所有248个III期试验开放在1993-2002年由5个临床试验合作组。问题涉及既往试验经验、试验设计要素、应计预测和感知的应计影响。根据临床试验合作组的记录得出应计充分性分类：充分应计包括完全应计或中期分析时结束的试验，不充分应计包括不充分应计结束的试验。响应进行了分析，受访者的角色（研究主席/首席统计师）和应计sufficient.Results三百零九个合格的答复包括（响应率，63%;首席统计师，81%;和研究主席，45%），代表试验有足够的（63%）和不足的应计（37%）。研究主席资历或主要统计学家经验与累积充分性无关。文献综述、研究主席的个人经验和临床试验合作组内的专家意见最常影响对照组的选择。临床试验合作组经验最受影响的应计预测。这些影响与应计充足性无关。在提到应计困难的受访者中（41%），对应计产生负面影响的因素并没有得到一致的确认。受访者记入三个因素与积极影响的权责发生制：临床相关性的研究，缺乏竞争的试验，并平行正常practice.Limitations的领导统计学家和研究主席的看法可能无法准确地反映参与医生或患者遇到的权责发生制障碍协议。调查结果可能会受到召回bias.Conclusion一致的因素解释不良应计未确定，提示不良应计的原因还没有很好地理解，值得进一步研究。由于临床试验合作组的经验与成功和不成功的累积有关，因此需要替代的累积预测策略。临床试验2011; 8：591-600。http://ctj.sagepub.com
Background Research on barriers to accrual has typically emphasized factors influencing participation after trial activation. Purpose We sought to identify factors influencing trial design and accrual predictions prior to trial activation associated with sufficient accrual.Methods A 30-question web-based survey was sent to the study chair and lead statistician for all 248 phase III trials open in 1993-2002 by five Clinical Trials Cooperative Groups. Questions addressed prior trial experience, trial design elements, accrual predictions, and perceived accrual influences. Accrual sufficiency categorization was derived from Clinical Trials Cooperative Group records: sufficient accrual included trials closed with complete accrual or at interim analysis, insufficient accrual included trials closed with inadequate accrual. Responses were analyzed by respondent role (study chair/lead statistician) and accrual sufficiency.Results Three hundred and nine eligible responses were included (response rate, 63%; lead statisticians, 81%; and study chairs, 45%), representing trials with sufficient (63%) and insufficient accruals (37%). Study chair seniority or lead statistician experience was not linked to accrual sufficiency. Literature review, study chair's personal experience, and expert opinion within Clinical Trials Cooperative Group most commonly influenced control arm selection. Clinical Trials Cooperative Group experience most influenced accrual predictions. These influences were not associated with accrual sufficiency. Among respondents citing accrual difficulties (41%), factors negatively influencing accrual were not consistently identified. Respondents credited three factors with positively influencing accrual: clinical relevance of study, lack of competing trials, and protocol paralleling normal practice.Limitations Perceptions of lead statisticians and study chairs may not accurately reflect accrual barriers encountered by participating physicians or patients. Survey responses may be subject to recall bias.Conclusion Consistent factors explaining poor accrual were not identified, suggesting reasons for poor accrual are not well understood and warrant further study. Alternate strategies for accrual prediction are needed since Clinical Trials Cooperative Group experience is linked to successful and unsuccessful accrual. Clinical Trials 2011; 8: 591-600. http://ctj.sagepub.com