Four Critical Factors for Clinical Trial Budget Success

Published on:
May 1, 2020
Written by:
Christopher Rao
Chris Rao

Planning a relevant and accurate budget, regardless of the trial phase or indication, can be one of the most challenging aspects of the clinical trial process.

Though it is one of the most integral and essential components of the program, clinical trial budgets are often overly bulky, missing fine details or just plain inaccurate. This results in the need to re-forecast and re-plan, delay or even close a trial due to insufficient or improperly allocated funds.

How can you ensure your clinical trial budget is airtight? By taking a realistic approach to clinical trial budget planning and execution. Consider these four factors when developing your budget:

  • 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.


Related news

Multimedia May 19, 2022
Fireside Chat Replay: Latest Developments in Oncology Supportive Care
In this fireside chat, we sit down with two medical experts in oncology and discuss some of the fascinating developments that are happening in the oncology supportive care field.
Events May 19, 2022
DIA 2022 Global Annual Meeting
We are pleased to announce that we will be joining DIA 2022 Global Annual Meeting as exhibitors and delegates.
Biometrics Clinical Life Sciences Regulatory
Events May 9, 2022
7e Journée start-up innovantes du dispositif médical
Clinical Digital Health Market Access MedTech Research & Development
Uncategorized May 6, 2022
U.S. and European Clinical Development for Asian MedTech Startups
This webinar will focus on the U.S. FDA and EU MDR/IVDR regulatory pathways and strategies for medical device startups based in the Asia Pacific.
Clinical MedTech
Multimedia April 28, 2022
Alira Health’s Transformation Talks: Real-World Data to Support HTAs in Europe
Learn more about RWD as a support in HTAs and its direct impact on HTAs budgets, results, and even patient outcomes by listening to this episode of Transformation Talks.
Clinical Market Access RWE
Multimedia April 15, 2022
Alira Health’s Transformation Talks: Real-World Evidence Strategy Playbook
As a special guest, our episode “Real-World Evidence Strategy Playbook” with Romain Finas, Vice President of Real-World Evidence at Alira Health, is now live! Listen to this podcast(...)
Clinical RWE
Multimedia April 13, 2022
Fireside Chat Replay: Clinical Trials in Rare Disease: Best Practices for Integrating the Patient Voice
This webinar will focus on the U.S. FDA and EU MDR/IVDR regulatory pathways and strategies for medical device startups based in the Asia Pacific.
Clinical Patient Engagement
Welcome to Alira Health. This site is best viewed in Chrome, Microsoft Edge, or Firefox.