Accurate and effective clinical trial budgeting is an interwoven web of dependencies that require perfect alignment to enable efficiency in study start-up and avoidance of costly amendments needed to address gaps downstream.
Study start-up traditionally involves a flurry of activity across multiple stakeholders; budget creation and parameter-setting are either deprioritized or rushed out to sites. If a site receives a budget that does not align with protocol requirements, it will extend the duration of budget negotiations, defeating the purpose of expedited distribution.
Protocol complexity, availability of supporting study documents such as lab, imaging, and pharmacy manuals, participant reimbursement, and logistics around investigator meetings are all components typically outstanding when initial budget offers go out the door to sites. Each contributes to delays in execution of site contracts and gaps in site budgeting, which result in costly budget amendments that balloon a sponsor’s anticipated study FTE and out-of-pocket (OOP) estimates.
Protocols are becoming ever more complex, and those tasked with building the budget are typically not from a clinical background. This added complexity translates into either overly complicated budgets or missed cost items. There are many demands on clinical operations teams in study start-up. However, if they are not involved in the detailed review and finalization of the budget (and specifically the invoiceables required per the protocol), their time required during budget negotiations increases exponentially. Clinical feedback in template development is key. If a clinician or clinical operations role reviews the initial budget build against his or her understanding of the protocol and confirms it covers the effort required to implement study activities, these roles are far less likely to require engagement during site specific budget negotiations. As such, they can focus their time on other start-up activities. Comprehensive clinical trial budgeting helps sponsors build trust with their sites, who are a crucial partner in ensuring study success. It is far easier to achieve the coveted “Sponsor of Choice” tagline when sites trust the sponsor’s budget was built to cover their needs to effectively implement a study onsite.
Lab, imaging, and pharmacy manuals offer clarification and refinement of protocol statements and are often finalized and distributed following a sponsor’s initial budget offer to sites. Finalizing budget templates in parallel with ancillary study manuals – especially in the absence of real clinical input in budget template development – will better inform budgeting and reduce the volume of additional clinical support during budget negotiations. For example, if the protocol requires an MRI at given time points but does not define the specific imaging requirements (functional MRI versus a standard MRI), the imaging manual can provide clarification. If this manual is not available at the time of budget finalization, the costing for an MRI against an fMRI may vary greatly and will impact parameter setting, negotiations, and time to agreement.
A sponsor’s approach to participant reimbursement – be it travel, stipend, or other – should be defined at the template development stage in both site contracts and the informed consent form (ICF). This item should be budgeted for appropriately as some countries or sites require specific reimbursement options and others will not allow stipends at all. Defining clear messaging, parameters, and language on participant reimbursement, will expedite this discussion with individual sites. Ensure a site’s ICF aligns with the participant reimbursement terms outlined in the site’s budget to avoid a contract amendment.
Sponsors should consider logistics around investigator meetings and be prepared to address during negotiations as this is a point of discussion sites will raise. For example, is the Investigator Meeting (IM) in person or remote? Will the sponsor cover Investigator and Study Coordinator travel to and from the Investigator Meeting? Ensuring IM travel and accommodations are budgeted for, including contract terms to adequately cover this component of study participation, will avoid unnecessary delays and unanticipated spend.
Clinical trial budgeting and the cycle times required to achieve budget agreement between sponsors and sites has increased exponentially in the last ten years. Ensuring the budget adequately covers the study’s requirements at the start of negotiations better positions the sponsor and site to work effectively toward a meaningful study outcome and reduces the administrative burden required to achieve agreement. If any or all of the items outlined here are addressed at the outset of negotiations, aggressive time to FPI may become more realistic and achievable.
