The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, supports five distinct research networks to conduct clinical trials on HIV/AIDS.
Currently, funding for NIAID HIV/AIDS clinical trial protocols is disbursed to the Leadership and Operations Center at each of the networks, which then remits funds to individual Clinical Research Sites (CRSs) around the world. Starting in 2017, NIAID will begin pilot testing a new funding stream where NIH disburses a portion of the protocol funds directly to Clinical Trials Units (CTUs) for further distribution to their component CRSs to cover the costs of already enrolled participants in HIV/AIDS clinical trials. Further, NIAID is forming working groups to develop templates and methods for standardization and capitation of protocol costs.
These pilot tests will determine if this method of funds disbursement provides improved oversight of taxpayer dollars while also reducing the administrative burden placed on CRSs and the networks. The pilots will conclude prior to making final funding decisions for the HIV/AIDS network grant cycle beginning in 2020. Expected benefits of this change include:
- NIAID will have increased oversight on how federal funds are allocated within each clinical trial.
- By providing some portion of the funds up front, NIAID will help CRSs – particularly those in areas with fewer resources – better plan operations and alleviate risk of funding delays on trial operations.
- The time it takes for funding to reach clinical research sites will be greatly reduced, which will allow trials to enroll participants without administrative delays.
- The changes will promote transparency and understanding of protocol costing among CTUs/CRSs, networks, and NIAID.
To understand the initial proposal on how the pilot tests will work, watch the archived webinar posted below, and review the questions and answers. NIAID welcomes your thoughts and suggestions on how to best implement these pilot tests. To provide feedback or ask additional questions, please use the comment form.