Questions & Answers: HIV/AIDS Network Refinement: Protocol Funds Revisited
Pilot 1: Funding Ongoing Participant Protocol Funds (PF) Expenses Through Clinical Trial Units (CTUs)
Pilot 1 aims to improve accountability of PF for all parties involved and provide NIAID with clear, consistent and accurate spending information to ensure more accurate stewardship of PF. The networks are accountable for ensuring that all necessary requirements are in place prior to initiating a new protocol and/or a new participant. For ongoing participants, it is appropriate and expected that the structure of the Clinical Trial Unit (CTU)/Clinical Research Sites (CRS) will facilitate a more seamless execution of support, budget planning and reimbursement. The CTU framework was developed and funded to provide oversight of funded CRS. For ongoing CRS expenses, NIAID will work with funded CTUs to assess funding of a CRS. Protocol specific sites will be supported throughout the protocol period via the network.
In terms of process, the leadership and operations center (LOC) will continue to submit PF recommendations to NIAID in April. Requests will be based on all protocol activity anticipated for the upcoming year. In May, NIAID will provide each network with proposed PF funding totals for all protocol activity for that network. In July, the networks will submit PF estimates of new and ongoing expenses by protocol for the entire next budget period. In September, the networks will take the earlier prepared estimates and submit a detailed distribution by CTU and CRS of ongoing expenses for actual participants on study as of August 31, 2017, as well as an estimate of anticipated enrollments from September 1, 2017 through November 30, 2017.
In July, the LOCs will request funds for all protocol activity in the upcoming year including an estimate of funds needed for new participants enrolled in network studies during the ‘gap’ period. In December, the CTUs will receive support to cover the entire year’s needs for the LOC verified actual ongoing participants that were on study through August 31, 2017. There will then be only three months of newly enrolled participants who will not have been included in the September data call and therefore, not part of the December CTU award. Grantees may use the flexibility provided in all awards to rebudget the funds as necessary to ensure the research continues until a revised final award is provided.
To ensure that the CTU receives all the funding they require for ALL ongoing participants, the LOCs would submit final FY 2017 numbers (for participants enrolled between September 1 and November 30, 2017) to NIAID by February 2018. NIAID is committed to revising the CTU Notices of Award (NoA) upward, as quickly as possible for the increased expenses for these participants enrolled during the gap period (September 1 – November 30, 2017).
Screening expenses will be included in the ‘new’ participant PF funding to the LOC, unless the screening costs have been built into the ongoing participant protocol costs. NIAID expects Pilot 2 to further address standardization of these processes.
The PF awarded to a CTU will be based on the anticipated cost amounts for supporting ongoing participants. These amounts will be provided by the LOC and accepted by NIAID.
NIAID will distribute PF for ongoing participants to the CTU. The CTU will then distribute funds to the CRS, based on number of ongoing participants. The CRSs should continue to work closely with the CTUs to ensure their funding is appropriate for the participants actively involved in their network studies.
Developing evaluation metrics/criteria will be imperative to determine whether the change has allowed the NIAID, networks and CTU/CRS to meet the goals discussed in the webinar, especially whether the pilot assisted NIAID staff in their responsibilities as stewards of federal funds. Exact metrics will be determined after discussions with appropriate stakeholders.
NIAID does not plan to revert to the current PF distribution process. Since the next competitive grant project period begins in FY 2020, we have two years to refine/enhance the PF distribution process based on feedback from this pilot and communications with appropriate stakeholders.
The total cost awarded for ongoing participants will be consistent with the LOC recommendations for ongoing participants, as approved by NIAID. NIAID will notify LOCs of any changes to their recommended PF allocations.
CTUs will have standard award authority to rebudget as necessary to ensure ongoing participant commitments are met. CTUs will need to ensure funds are provided to the CRS appropriately.
PF for the LOC will include the estimates of potential new protocols and new participants starting December 1, 2017; however, this figure is based on estimates and may change over time. Therefore, NIAID will provide a portion of the LOC PF for potential new participants with the LOC type 5 in December 2017, and release an appropriate portion of the remaining PF in June 2018, assuming a bona fide need exists.
PF amounts will continue to be calculated by the networks and submitted to NIAID. Upon approval, NIAID will ensure that the LOCs, and the CTU/CRSs are advised if PF amounts awarded are adjusted.
This issue is important and will be discussed in the near future with the LOCs and representative CTU/CRS staff as part of the pilot process. To be clear, in FY 2018, the CTU awards will include all PF for ongoing participants enrolled on or before November 30, 2017.
In the rare event that a study is stopped and/or a significant number of anticipated study visits for ongoing participants are discontinued, NIAID will work closely with the affected CTUs to determine how best to use unspent funds.
Each network has developed a unique set of procedures for PF distribution. The only way to understand the impact of these Pilots is to review their outcome in each of the HIV/AIDS networks.
Not at this time. The PF allocations to these network grantees will not be affected by these pilots. In addition, the Laboratory Center (LC) and SDMCs will continue to be involved in discussions of overall protocol costs with the LOCs, including the determination of the date of enrollment (new vs. ongoing participants) as applicable.
SDMC and LC funds are not expected to transfer into the CTU award. The PF funds under consideration in this pilot is only the PF funds that are currently being distributed to the CTU/CRSs from the LOC for ongoing participant protocol expenses.
There may be some changes in what the SDMC does to help develop PF estimates. In addition, the networks must be able to identify new and ongoing participants to determine appropriate PF cost distribution by ongoing vs new participants. It is expected that SDMCs may need to add some additional database elements to ensure that identification of each network’s ongoing participants is accurate and consistently applied.
Pilot 1 funds will apply to funds coming from other NIH ICs. This method of PF distribution will not apply to funding from non-NIH sources, including foundations and pharma.
The proposed Pilots should strengthen the CTUs role to assist a CRS in fiscally managing the support provided. The networks will continue to provide PF directly to the CRSs for new participants. In addition, CTUs will provide the PF for ongoing participants.
The CTU framework was developed and funded to provide that oversight of funded CRS. The April 2012 Clinical Trials Units for NIAID Networks RFA stated that the CTU is to provide “…coordination, fiscal management, and administrative support for all activities of the CTU”, which includes oversite of the CRS(s). NIAID recognized in the RFA that a CRS’s ability to manage the funds they are provided is paramount to the success of the CRS to perform the work supported within the CTU.
With the current PF funding model, some LOCs have been awarded PF for expenses that are not for either a CTU or a CRS cost. Only the portion of the PF for ongoing protocol participants at a CTU supported CRSs will be transferring to the CTU.
Protocol start-up funds are considered new protocol expenses, and therefore will be distributed through the LOC award.
While the aim is to improve accountability and transparency in PF spending, we also want to maintain the flexibility in the LOC awards to address new protocols and/or enrollment challenges.The current model limited flexibility to redistribute funds in a timely manner.
The CTUs are funded to provide scientific contribution to HIV/AIDS network scientific agendas, and to implement protocols as part of the HIV/AIDS networks for which they are funded. Limited observational studies are not part of the scope of the CTU and therefore cannot be supported by NIAID and the CTU.
It is anticipated that these two submission dates will remain applicable to future years. The LOCs will continue to work with NIAID to provide requests for protocol funding for the coming year (April), and then refine the request based on the approved DAIDS budget (July). However, modifications and adjustments may be made to timelines based on the results of the pilot program and other funding needs.
NIAID will evaluate the accuracy of funding requests. As part of the evaluation, NIAID will most likely require CTUs to provide information on how PF funds were allocated and spent per network. The evaluation metrics are in development, but at this time it is not expected that the CTUs must report by cost category or actual visits.
Pilot 2: Standardization of PF expenses within and across networks, and the use of capitation
The purpose of Pilot 2 is to standardize protocol costs across all networks and to evaluate the feasibility of implementing a capitation cost model for PF distribution.
Standardization/capitation cost models have not been determined yet. It will be the goal of the Pilot 2 Working Group to propose the best protocol costing model solution(s) for consideration by NIAID. The goal is to identify a model(s) that will be implemented by all LOCs for new protocols.
Standardization/capitation models will not be retroactively applied to ongoing protocols. The cross-network protocol costing proposal, which needs to be submitted by the Pilot 2 Working Group to NIAID in January 2018, will be applied to all new protocols only after the final model is approved by NIAID.
While other recommendations were also made following the visits, the recommendations outlined in these two pilots were considered the most effective means to enhance stewardship of PF funding.
The composition of the PF Pilot 2 working group will aim to balance expertise with representation from a diverse group of stakeholders. Interested parties may submit a request to NIAIDDAIDSPFPilot@niaid.nih.gov by March 29, 2017 for consideration.
The Uniformed Administrative Guidance does not specifically provide information on why capitation awards do not have to follow the cost principles.
When evaluating standardization and capitation, it will be imperative to review the impact of the modeling tools developed.
CTI is an unpredictable cost needed prior to study implementation and as such should be part of the PF provided to the LOC for distribution through their subcontracts with the CTU/CRSs.
There is no expected change in the distribution of LOC funding of PF. PF for new protocols and new participants will be distributed by the LOC to the CTU/CRSs via subconcontracts, as defined by each network.
It is currently expected that theCTU PF for ongoing participants will be distributed based annual expenses rather than by milestone reimbursement.
Yes, CTUs are expected to use core funds and PF to ensure their commitments for protocol activities across networks are met. They may re-budget as necessary, per NIH Grants Policy, to meet the specific aims of the CTU.
PF will be provided, as determined by the LOC, in a cost-per-participant amount and will include costs for all predictable protocol expenses. Unforeseen expenses such as additional visits due to adverse events would continue to be paid through the LOCs as unanticipated protocol expenses.