Effort Required in Eligibility Screening for Clinical Trials
Effort Required in Eligibility Screening for Clinical Trials
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DOI：
10.1200/jop.2012.000646
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发表时间：
2012-11-01
影响因子：
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通讯作者：
DeShazo, Jonathan P.
中科院分区：
文献类型：
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作者：
Penberthy, Lynne T.;Dahman, Bassam A.;DeShazo, Jonathan P.
目的：确定临床试验（CT）的资格通常需要对单个评估的数据进行长时间的人工审查。与资格筛选相关的费用通常不会通过支持ct的合同得到补偿。方法：我们使用实时跟踪系统来获取CT评估，并提供评估结果和研究人员在每次资格筛选上花费的时间的信息。使用这些数据，我们描述了总体和每个入组癌症ct患者的合格筛查的努力和成本。研究样本包括18个月研究期间所有完成的合格性评估（评价）记录。我们使用广义多项模型来预测评估结果，然后使用得到的参数系数来估计与每个参与者相关的努力，并根据入选概率进行调整。根据这些数据，我们计算了与资格筛选相关的成本。结果：我们发现不同研究类型和阶段的归因成本有很大差异。每个入组患者的合格筛选费用从129.15美元到336.48美元不等。每年的筛查费用估计超过9万美元。结论：本研究提供了基于前瞻性捕获努力的结果，以估计资格筛查的大部分未报销成本，并表明筛查可能是一个机构的重大经济负担。在与资助机构谈判合同时，执行ct的中心可能需要承认不同研究类型的筛查费用的差异。这里收集的资料可以支持这种谈判，以缩小已报销费用和未报销费用之间的差距。
Purpose: Determining eligibility for a clinical trial (CT) typically requires a lengthy manual review of data for a single evaluation. The cost associated with eligibility screening is typically not compensated through contracts supporting CTs.Methods: We used a real-time tracking system that captures CT evaluations and provides information on evaluation outcomes and time spent on each eligibility screening by research staff. Using these data, we describe the effort and costs of eligibility screening overall and per enrolled patient for cancer CTs. The study sample included all completed eligibility assessment (evaluation) records for the 18-month study period. We used generalized multinomial modeling to predict evaluation outcomes and then used the resulting parameter coefficients to estimate the effort associated with each participant, adjusted for probability of being enrolled. From these data, we calculated cost associated with eligibility screening.Results: We found substantial variation in attributed cost by study type and phase. The cost of eligibility screening ranged by study phase from $129.15 to $336.48 per enrolled patient. The estimated annual cost of screening was more than $90,000.Conclusion: This study provides results based on prospectively captured effort to estimate the largely nonreimbursed costs of eligibility screening and suggests that screening can be a significant financial burden to an institution. Centers performing CTs may need to acknowledge the differences in screening costs for different study types when negotiating contracts with funding organizations. Information such as that captured here could support such negotiations to reduce the gap between reimbursed and nonreimbursed costs.