Four Critical Factors for Clinical Trial Budget Success

• Be realistic: Unrealistic timelines and cost ceilings are frequently pushed down from the top. Understand where you can shave time (and costs) off your trial plan and where it is simply not possible. A realistic view of costs, though sometimes painful, will help you plan for the necessities of the trial and will avoid “wishful thinking”. Examples of timelines which can only be minimally shifted are institutional startup timelines (such as IRB review) and regulatory timelines set by FDA or other agencies.

• Understand your indication: Each indication is unique as it relates to subject accrual, institutional reimbursement and standard of care vs. protocol-required procedures. By having a firm grasp on the nuances of your patient population, you will be better equipped to estimate subject costs, institutional fees and enrollment rates at the site level, all of which have a direct budgetary impact.

• Look for hidden costs: Sponsor companies are often plagued by “hidden” costs, such as clinical equipment rentals and unanticipated invoiceable study procedures at the site level, as well as study delays and other timeline changes which increase costs. Plan for the unexpected by building a cushion into your trial budget. Some sponsor companies will increase study-wide costs by a 5-10% margin, ensuring that an unanticipated delay or increased cost is not a budget-breaker.

• Compare Service Providers: Not all service providers are created equally. When budgeting for items such as data management, clinical site monitoring and pharmacovigilance, your chosen service provider should be able to provide you with a clear, concise and understandable explanation of projected charges. While change orders are sometimes a necessary evil, a good service provider should ensure that these are the exception, rather than the norm.

Taking a practical and measured approach to clinical trial budgeting will help you build an initial trial budget that is as accurate as possible and provide some cushion to help weather unexpected storms that may pop up during your trial. With these factors in mind, you’ll be well on your way to success, without breaking the bank (or your budget).

Chris Rao is the Vice President, Clinical Development. Chris has over 15 years of experience in clinical research, with a focus on trial design and management.