It should come as no surprise that conducting a clinical trial is expensive. Just how expensive depends on the phase and design of the trial, with costs typically increasing with phase and complexity. A recent Tufts study has found that Phase III oncology trial budgets exceeded $65 million while non-oncology trial budgets were at ~$54 million.1 Other sources have estimated even higher costs.2
Sponsors are interested in keeping their budgets stable and reigning in out-of-scope costs that can skyrocket budgets due to study changes, including delayed enrollment, protocol changes and erroneous initial budget estimates. What are some of the challenges and subsequent tips to keeping a trial on-time and within budget? Let’s start with upfront activities.
Initial Estimation of Costs – Getting it Right From the Start
Trials that are outsourced to CROs for all or a portion of services can expect the service costs within the following categories, presented in descending order of a typical study budget:
- Site management and monitoring – usually the largest part of the budget and depends on therapeutic area, number of patients, sites, length of trial and method of source data verification
- EDC build, clinical data management– cost driven by number of patients, complexity of CRF (Case Report Forms), length of trial, different types of external sources of the data, type of EDC database selected
- Biostatistics and statistical programming – cost driven by complexity of protocol and study design (e.g., adaptive, number of endpoints), duration of study (e.g., number of interim runs) and reporting needs
- CRO Project management, risk-based management – cost depends on study duration, study complexity, number of sites and countries, study milestones, delivery models (e.g., Agile or Waterfall)
- Medical writing- cost depends on the complexity of the therapeutic area, phase of the trial, number of regulatory documents
- Pharmacovigilance- cost depends on type of database, therapeutic area with an estimation of Adverse Events and SAEs (Severe Adverse Events) reported
Budgets are drawn up for activities within each of these areas, based on a near final protocol and comprise the ‘scope of work.’ A CRO will work with sponsors to develop a budget proposal based on an agreed upon scope of work. This can be a ballpark, preliminary estimate or a detailed appraisal with corresponding tasks and activities.
- The ballpark is meant to give a price range for high level objectives.
- A detailed budget proposal should reflect an understanding of the trial’s needs in sufficient detail to provide a sponsor with enough information to compare competing proposals and illustrate the appropriateness of the budget for activities.
5 Tips for Success
- Be clear and reasonable about timeline expectations – a turnaround for a ballpark estimate will take less time than a more detailed and comprehensive budget response.
- A clear, well-structured, and detailed set of upfront information sent to the CROs will result in a more accurate budget response.
- For better comparability between different vendors, specify the needed information to be provided for a budget response.
- Look for a thoughtful response that indicates experienced staff have considered the needs of your study and not just run the numbers to generate a generically produced document.
- Don’t focus only on the bottom-line budget number for the lowest estimate. A good CRO should provide a realistic and comprehensive proposal for services that will meet the needs of your study and provide options for expected challenges (e.g., delayed enrollment? changes due to regulatory requirements or requests?)