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

ABSTRACT: BACKGROUND: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. METHODS: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

SUBMITTER: Lovegreen O 

PROVIDER: S-EPMC5934907 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature