Heather S. Friar, clinical research associate, IMARC Research

Understanding the cost of something is important when making a financial decision both professionally and personally.  It is imperative that one understands the cost of an item which includes the extra fees that may not be visible on the price tag.  

The same is true in conducting clinical research trials.  After the sponsor has selected a site to participate in the clinical trial, one must understand the overall cost of the study to determine if conducting the study is feasible.  It is necessary to review the clinical trial study budget and clinical trial agreement before committing to conducting the study.  Since most clinical trials are conducted on a set budget, due to the securing of federal and/or private funding and grant money, there is not much flexibility in making big adjustments once the study has started, as most funds are already allocated.   

For the study site, it is important that one understands the potential “extra” costs when determining feasibility.  The following, at a minimum, should be considered:

• Review all of the documents and footnotes.  
• Perform the cost per participant for the entire study.  
• Determine if the budgeted amount will cover the costs of the participants.  
• Determine if the staffing at the site is adequate to oversee the trial through study closure.
• Determine if the site has the necessary equipment and resources to conduct the study which includes storage and shipping costs.  

There are so many “extra” costs in a clinical research study that must be included in the overall allocation of the study dollars.  Although not all scenarios of a clinical study can be explored and budgeted, it is however important to make sure the funding is allocated appropriately and the study can be conducted as proposed. 

For the study sponsor, underestimating the overall cost of conducting the study can jeopardize the study as the study may have to prematurely end as the funding has run out and additional funds are unable to be secured. While most study sites are not in the business to make an exorbitant amount of money, they need to remain competitive and continuing a study that has run out of budgeted money will tap into the profits of the site.  Overestimating the overall cost of conducting a study can have an unfavorable effect on future studies for a sponsor as well.  If funds are available after the clinical trial has completed, they should be returned to the financial supplier and be allocated for a different use or study.  If money is not returned by the sponsor to the lender, future requests may be denied making the financial funding of a clinical trial difficult to secure for that sponsor.  

Researchers must appreciate the overall value and importance of clinical trial agreements and study budgets when determining site feasibility.  Securing adequate funding is attributable to the success of any clinical research study.  Having the ability to identify the “extra” costs can directly have an impact on the overall cost and conduct of the study.  By having a strong work ethic, integrity, a strong reputation for great service and being financially competitive, sponsors will continue to utilize the study site for clinical studies both current and future.  Lastly, the study site must be able to confidently determine if the study is feasible and able to be conducted at their site.  

Please share your thoughts on study feasibility and how the study budget impacts your overall decision as the sponsor to select a site to participate in a clinical research trial or your overall decision as the site to participate in a clinical trial.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.