Financial management of large, multi-center trials in a challenging funding milieu

• Published in: Current controlled trials in cardiovascular medicine Vol. 19; no. 1; p. 267
• Main Authors: Lovegreen, Olivia, Riggs, Danielle, Staten, Myrlene A, Sheehan, Patricia, Pittas, Anastassios G
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 03-05-2018; BioMed Central; BMC
• Subjects: Budget; Budgets; Cholecalciferol - administration & dosage; Cholecalciferol - adverse effects; Cholecalciferol - economics; Clinical trial; Clinical trials; Costs; Diabetes; Diabetes mellitus; Diabetes Mellitus, Type 2 - diagnosis; Diabetes Mellitus, Type 2 - economics; Diabetes Mellitus, Type 2 - epidemiology; Diabetes Mellitus, Type 2 - prevention & control; Dietary Supplements - adverse effects; Dietary Supplements - economics; Enrollments; Financial management; Financing, Government - economics; Financing, Government - legislation & jurisprudence; Funding; Government finance; Government Regulation; Health aspects; Health Care Costs; Humans; Hybrid; Incidence; Models, Economic; Multicenter Studies as Topic - economics; Multicenter Studies as Topic - legislation & jurisprudence; National Institutes of Health; National Institutes of Health (U.S.) - economics; National Institutes of Health (U.S.) - legislation & jurisprudence; Nonprofit organizations; Patient Selection; Public Sector - economics; Public Sector - legislation & jurisprudence; Randomized Controlled Trials as Topic - economics; Randomized Controlled Trials as Topic - legislation & jurisprudence; Reimbursement; Reimbursement Mechanisms; Review boards; Risk factors; Time Factors; Treatment Outcome; United States - epidemiology; Vitamin D; United States; United States > US; Financial management; Hybrid; Clinical trial; Budget; Diabetes; National Institutes of Health
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-018-2638-z

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.