The key pillars of clinical trial budgeting: preparation and flexibility

12th August 2015 (Last Updated July 16th, 2018 10:12)

As budgets for clinical development become tighter, Kieran Prior explores some key factors for cost management and control

The key pillars of clinical trial budgeting: preparation and flexibility

With the cost of clinical trials on the rise, and stricter budgets being impressed upon clinical teams, it has become harder and harder for sponsor companies to keep their costs under control whilst still ensuring quality results and regulatory compliance within required timelines. Add to this the growing amount of activity that is outsourced to CROs and other service providers, and effectively controlling costs can be a near impossible task.

It is becoming more and more commonplace for sponsor companies to use clinical trial cost tracking technologies to provide an efficient way of both calculating and managing cost accruals whilst also providing financial forecasts for the trial. Sponsors are trying to incorporate these sorts of technologies from the earliest stage and utilizing them to set the clinical budget during the protocol development. However, despite use of all the technology available, accurate forecasting of budgets may not be achieved if sponsors are not properly prepared. With an almost limitless number of factors and unexpected issues that can affect trial costs, a 100% accurate forecast is not a realistic target, nevertheless there are a number of steps companies can take to ensure their forecast is as reliable as possible.

Some factors companies should be investigating in depth, on top of standard vendor costs, include:

  • Evaluating the target patient population to calculate recruitment and advertising costs required to meet enrolment targets
  • Considering the number of sites required as well as associated staffing costs
  • Start-up costs, such as training investigators and CRAs into any necessary specifics of the trial and site selection/initiation
  • Noting any specific, and potentially expensive, equipment/tests that will be required
  • Understanding the needs of the clinical supply chain; for example, what level of temperature maintenance would be necessary
  • Forecasting the costs of any IRB and Ethical Committee fees
  • - Close-out activities

Additionally, sponsors should always consider how the growth of the trial will impact the costs, and when these cost increases will happen. For example: will the trial be moving to other geographical areas, will additional vendors will be required, at what level will your CROs be outsourcing to third parties, and at what point in the trial is the sponsor going to be expected to shell out for these costs? Sponsors should also be aware of annual cost increases for already budgeted items; this is something that is often forgotten in budget forecasting and for longer trials can have a substantial impact.

Even with all these considerations and due preparation, there will always be unexpected costs and sponsors need to allow for some flexibility. The majority of these cost increases come from the same 4 areas:

  1. Trial Overruns - As a trial timeline becomes more and more delayed due to missed patient enrolment targets, monthly costs continue to add up with huge impact on trial budgets
  2. Protocol amendments - As the protocol becomes more complex (especially midway through a trial) with changes to monitoring strategies and patient testing etc the costs have the potential to rise dramatically
  3. Adding New Sites - The standard response to missed patient enrolment targets is adding new sites, resulting in additional start-up, training and monitoring costs being added to the budget
  4. Changing Vendors - One of the most cost-impactful decisions a sponsor can make mid-way through the trial. Often seen as a last resort, this may be a necessary evil but has a huge cost impact on the trial

Historically, sponsors of all sizes have a disappointing record of managing trial forecasts. To do this effectively, companies need to capitalize on cost-management tools and start using them and implementing their results at the earliest stage possible. Ensuring this is done accurately is not an easy task and this responsibility often rests on the shoulders of the more junior members of a sponsor company. Clinical project managers have to be able to provide a great level of detail on their trials and update systems of the smallest change. A tiny change to costs at an early stage can have a huge impact when scaled up across multiple sites in a variety of countries, so it is essential even changes that seem insignificant are communicated and recorded. The financials are, of course, not often high priority in the mind of the clinical project manager so this mindset needs to be installed in all sponsor staff to promote more effective trial budgeting.

Trial budgeting and forecasting has for a long time been a real challenge for sponsor companies both big and small. However, with the advent of more advanced cost tracking technologies and a change of mindset from top to bottom within sponsor companies, the future looks bright for more accurate budgeting even in the face of more complex and intricate trials.