Reconciling Your Clinical Trial Protocol Start-Up Costs and Budget
As clinical trials protocols have grown more complex and more disparate teams are working on different elements of executing them, there is a potential for incongruency between the protocol requirements and the budget. It is critical to engage the stakeholders that will have a part in carrying out the research in the budgeting process. All departments must ensure their costs related to facilitating the research will be addressed in the study budget. Failing to include key stakeholders in the process can lead to financial losses or a lack of commitment from stakeholders that are critical to successfully achieving the established goals for the study.
Even if a site is diligent about including ongoing costs such as the procedures associated with each patient visit, pharmacy costs, and radiology costs, some of the start-up costs may be overlooked. These are some of the key areas of risk in developing a budget.
Administrative start-up
Before a study even starts, research sites will incur certain expenses related to site selection activities, and training staff on the study protocol. Even items such gaining access to the sponsor’s web based portal can require the support of IT to adjust system configurations that permit access to such portals.
It may seem minor, but the time and effort it takes to develop a budget should actually be in the budget. In fact, other activities required for start-up, such as meetings with other departments and coordinating the start-up paperwork, should also be part of the overall administrative budget.
Consent Forms
The preparation and review of consent forms is also a cost often overlooked.
For example, a research site may need to translate consent forms into different languages (depending on the community it serves) for non-English speaking participants.
Screening costs
Not every patient is qualified to participate in a clinical trial, so there are screening costs. Your site may have to screen several people for each person who actually gets into the trial. These are called “screen failures,” and they take time and effort.
Training
In addition to ongoing training of staff, certain protocols may require specific additional training to ensure compliance or appropriate recruitment of patients.
Other department costs
Does your clinical or research lab, or pharmacy, have start-up costs to prepare for the initiation of this clinical trial? Investigators should understand the implications for other departments on whom she is dependent for the successful launch of the trial. Other costs to consider in the budget for other departments are annual maintenance fees and close out fees.
IRB
The research coordinator needs to prepare documents for IRB review. Even if your site uses a local IRB, those fees should be included. You may also want to include an annual or quarterly fee to cover staff time for management and maintenance of the research project and submission to the IRB for continuing review approval.
It is critical that an investigator or research coordinator understands all the tasks and procedures that impact the execution of research protocol and develops a complete and accurate budget. The sponsor’s template budget will not generally include all the budget elements, especially those related to administrative start-up, which may not be obvious. Carefully review all protocol related costs, discuss the protocol with key stakeholders, and be prepared to negotiate with the study sponsor to secure the fees needed to cover the study costs.
