Frequently Asked Questions about Budgeting a Multisite Clinical Trial in a PBRN
1) Who needs to be involved when first developing the budget for a multisite clinical trial with a PBRN?
A clearly designated scientific lead and administrative lead develop the budget and sub-budgets.
If the team leading the clinical trial is different from the PBRN core team, it is critical to include a scientific and/or administrative representative from the PBRN. These individuals understand both the grant budgeting process and what the practices and the PBRN will need to support the research. The practices will not be at the table except under unusual circumstances.
- Work with the PBRN core team to identify the overall structure of the budget (e.g., lead organization, affiliated organizations, subcontracts, consultants)
- Develop a scope of work for the lead organization, affiliated organizations, and subcontracts which will determine the budget required for each task.
- Develop an initial budget, including funds for conduct of work at the practices. Costs may vary at each practice based on regional salary levels and other factors, such as structure of the participating practices and PBRNs. Make sure the budget allows funding flexibility in case some practices and PBRNs are more expensive than others.
- Share relevant aspects of the budget with practices if appropriate once funding limits are clear.
- Make sure the budget draft is agreed upon by those with institutional or practice authority after finishing the specific aims and before scientific writing begins to make sure the project is feasible and to make sure the science fits the budget.
When the PBRN sits in a typical academic institution, the prime organization is generally the university, regardless of whether the PI sits in the PBRN or not. The university will subcontract and develop consulting arrangements with health systems, practices, and their personnel.
When the PBRN and the PI sit in a non-profit organization, and other investigators sit in an academic institution, then the PBRN will hold the primary budget and subcontract with the university.
When the PBRN sits in a non-profit organization (e.g., DARTNet Institute) and the PI sits in an academic institution, then the budget structure depends on which organization is serving as the lead:
- If the university is lead, then the PBRN will subcontract with the university as outlined above.
- If the PBRN is lead, then the PI and the rest of the academic
team may develop a subcontract with the PBRN. Examples of this situation
include center grants that the PBRN is submitting, or grants from
sponsors that the PBRN is working with but recruits a scientific lead
from a university.
- Note: Many universities require that the university serve as the lead institution for a grant if one of their faculty members is the PI. PIs need to discuss this with their grant and contract offices well in advance of the budget planning period so that there are no complications in creating the budget.
The first rough budget draft should be completed no later than six weeks before the grant due date.
Make sure the budget limits are clear before the approach is developed. It can be expensive to work with multiple collaborators, and it is important to avoid an approach that outstrips the budget limits.
The final budget, including all sub-contracts, should be finalized no later than three weeks before the grant due date if possible. Consortium agreement letters should be in place at the prime institution at least one week before the due date.
5) If a freestanding PBRN and a university are collaborating on a grant proposal, how can the proposal be a win-win situation?
Both organizations will want the recognition of being the lead organization on the proposal, so consider a co-PI-ship between the lead academic and PBRN investigators.
Ensure optimal allocation of the budgets so that each institution receives adequate indirect cost returns, anchored on the expertise provided by each institution (e.g., practice facilitation, research coordination, or payment of incentives and consultants may best be accomplished by the PBRN; payment of academic investigators by the university).
6) Why would a PI want to develop subcontract arrangements with a PBRN that has a non-profit structure?
PBRNs with non-profit structures may be able to more easily and efficiently pay incentives and honoraria to practices and patients, and pay consultant fees to practice personnel. They may be more familiar with incentives and honoraria payment to practices and health systems.
Non-profit PBRNs may have lower indirect cost rates, so grants with total cost limits may be more feasible if some grant functions are assumed by these PBRNs.
There may be more dollars available for direct costs if working with a PBRN or practice that charges indirect costs for only certain budget items (e.g., personnel). This could direct the choice of partners for a project.
7) What budget elements need to be included in a multisite PBRN-based budget that investigators donít usually include?
Practice Lead Physician/Clinician FTE Ė Depending on the PBRN and the project, Practice Lead Physicians/Clinicians serve as collaborating investigators. Adequate time should be budgeted for engagement of practice clinicians and administration, IRB processes, team meetings, and manuscript review.
Practice honorarium/incentives/payments Ė This is funding for use of practicesí facilities, time spent by practice staff on any clinical trial processes, practice administration involvement, time spent answering questions about the trial to inquiring patients, appreciation for willingness to be involved themselves and to involve their patients in the clinical trial. Informed consent processes with patients within the practice is time consuming, and needs to be adequately compensated.
PBRN central research project team costs Ė A PBRN Investigator is important to translate a clinical trial to the primary care setting, help the academic research project team understand the primary care clinical constraints and factors relevant to the trial, help disseminate trial findings back to the practices in a practice-friendly way (e.g., powerpoint that Practice Lead Physician/Clinician can share with the practice); PBRN Coordinator to coordinate the conduct of the trial at the PBRN practices, to ensure clinical trial procedures are conducted appropriately at the practices (e.g., IRB, Data Use Agreements, communications, meeting scheduling, practice-friendly materials development -- this is separate from research project staff who work with patients), and to serve as the PBRN contact for both participating practices and the academic research project team and/or PI. The PBRN central research project team needs an adequate budget to take on tasks that might not be feasible for a busy practice or that the practice may not have expertise in (e.g., IRB, survey dissemination).
PBRN infrastructure costs - It is important to build in a PBRN infrastructure fee to cover the basic costs of maintaining a PBRN and its trusted relationships and processes (e.g., annual meetings, communications, data sharing infrastructure).
- Annual fixed costs for practice personnel for IRB and regulatory work when appropriate (these are costs that are incurred regardless of patient enrollment).
- Data costs Ė extraction of data
- Costs of training personnel on-site or off-site to take part in the trial (e.g., standard operating procedures for the trial protocol)
- Site visit costs (e.g., travel, accommodations, meeting expenses)
- Costs of disseminating the findings back to the practices in a practice-responsive fashion
- Provision of data sets to the practices for their own analysis, or providing data reports to the practices, as agreed upon and if desired.
8) What is the best way to structure a budget so that the practices receive payment upon completion of required tasks?
Divide practice-required study tasks into timed milestones that are linked to payment.
Maintain a set of principles when addressing budgets and budget changes:
- agree on what is core to the trial, and donít cut core budget areas
- be transparent about budgets, and budget changes or cuts
- academic and PBRN leaders make decisions, but check these decisions with all of the investigators and subcontractors to make sure the trial can still go forward.
10) What happens if the academic research project team hasn't finished the study analyses and there are no further grant funds to complete the work?
It is important that the academic research project team meets its obligations to the practices and the PBRN so that trusting relationships are maintained and the practices are willing to participate in future research projects. This includes dissemination of findings back to practices in a practice-responsive form and making data sets available as agreed upon.
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