Financial management of large, multi-center trials in a challenging funding milieu.
Financial management of large, multi-center trials in a challenging funding milieu.
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DOI：
10.1186/s13063-018-2638-z
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发表时间：
2018-05-03
期刊：
影响因子：
2.5
通讯作者：
Pittas AG
中科院分区：
文献类型：
--
作者：
Lovegreen O;Riggs D;Staten MA;Sheehan P;Pittas AG
具有公共卫生影响但没有或低商业收益潜力的随机临床试验主要由政府资助（例如，美国国立卫生研究院（NIH））和非营利组织。我们的目标是开发一种替代的临床试验基地的资金分配模式，明智的下降公共研究资金。在维生素D和2型糖尿病（D2 d）研究中，一项由NIH支持的大型临床试验测试了维生素D补充剂对2423名糖尿病高风险参与者的糖尿病发病率的影响，开发并应用了一种支持合作临床站点的混合财务管理模型。该资助模式采用两种报销部分：核心（用于研究启动和整个研究期间的部分工作，约占研究中心总预算的40%），由研究中心开具发票，以及基于绩效的付款（用于成功入组受试者和完成随访访视，约占研究中心总预算的60%），由协调中心根据实际招募和进行的访视自动向研究中心发放。业绩不佳的营业点仅过渡到基于业绩的付款。征聘时间为2013年10月至2016年12月，比2年预测多需要一年。每家临床试验机构的中位入组人数为88例受试者（范围29-318;临床试验机构目标的20 - 205%）。在第1年结束时，整个研究范围内的招募量为目标的12%（预计为50%），总补助金的12%用于投资。该模型不断评估研究中心的需求并重新分配资源，以满足研究入组目标。如果D2 d发布了费用报销子协议，并且研究中心为其全部预算开具发票，则83%的奖励将用于试验前4年的所有研究活动，而在D2 d使用的混合模式下，则为65%的奖励（2600万美元）。促进混合财务管理方法是可行的，以动态和一致的方式管理有限的可用公共资金用于研究，不损害试验的科学完整性，并确保节省资金以完成招募并继续随访参与者。
Randomized clinical trials that have public health implications but no or low potential for commercial gain are predominantly funded by governmental (e.g., National Institutes of Health (NIH)) and not-for-profit organizations. Our objective was to develop an alternative clinical trial site funding model for judicious allocation of declining public research funds. In the Vitamin D and Type 2 Diabetes (D2d) study, an NIH-supported, large clinical trial testing the effect of vitamin D supplementation on incident diabetes in 2423 participants at high risk for diabetes, a hybrid financial management model for supporting collaborating clinical sites was developed and applied. The funding model employed two reimbursement components: Core (for study start-up and partial efforts throughout the study, ~40% of the total site budget), invoiced by sites, and Performance-Based Payments (for successful enrollment of participants and completion of follow-up visits, ~60% of the total site budget), automatically issued to the sites by the Coordinating Center based on actual recruitment and visits conducted. Underperforming sites transitioned to Performance-Based Payments only. Recruitment occurred from October 2013 through December 2016, requiring one additional year than the 2-year projection. Median enrollment at each site was 88 participants (range 29–318; 20 to 205% of the site target). At the end of year 1, study-wide recruitment was at 12% of the target (vs. 50% projected) and 12% of the total grant award was invested. The model constantly evaluated sites’ needs and re-allocated resources to meet the study enrollment goal. If D2d had issued cost reimbursement subaward agreements and sites invoiced for their entire budget, 83% of the award would have been spent for all study activities over the first 4 years of the trial compared to 65% of the award spent (US$26M) under the hybrid model used by D2d. It is feasible to foster a hybrid financial management approach to steward limited available public funds for research in a dynamic and consistent way that does not compromise the trial’s scientific integrity and ensures conservation of funds to complete recruitment and continue to follow up participants.
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DOI：
10.1177/1740774515625974
发表时间：
2016-04
期刊：
Clinical trials (London, England)
影响因子：
--
作者：
Larson GS;Carey C;Grarup J;Hudson F;Sachi K;Vjecha MJ;Gordin F;INSIGHT Group
通讯作者：
INSIGHT Group
影响因子：
16.2
作者：
Pittas, Anastassios G.;Dawson-Hughes, Bess;Staten, Myrlene A.
通讯作者：
Staten, Myrlene A.
影响因子：
16.2
作者：
American Diabetes Association
通讯作者：
American Diabetes Association
影响因子：
120.7
作者：
Lappe, Joan;Watson, Patrice;McDonnell, Sharon L.
通讯作者：
McDonnell, Sharon L.