In a February 2013 Clinipace-sponsored webcast on “The Joys and Woes of Clinical Trial Start-Up,” participants were polled on what percentage of total trial costs they devoted to study start-up. The wide range of responses was intriguing (Figure) and got us thinking about how these results compare to the industry as a whole.
Figure: Results of the audience poll question, “What percentage of your overall project study budget is devoted to start-up related activities and processes?”
What we found (or failed to find) was any study start-up costs data to compare with our informal poll. There are, however, a number of studies that examine timelines associated with study start-up. In particular, a recently published article by Lamberti, et al. (Therapeutic Innovation & Regulatory Science. 2013;47:101) benchmarked the process using data from 11 pharmaceutical companies initiating 105 global clinical trials at total of 5,296 sites. We identified 5 key factors that may, at least in part, explain how start-up costs can be less than 25% of some study budgets but greater than 75% of others. It is obvious, that the longer the start-up timeframe, the greater the budget needed to go towards it since, besides costs to sites to get them activated, there is the cost of managing everyone working on the project as well as the lost revenue for every day a product is not marketed.
- Definition of “study start-up”: When does the clock begin (eg, at protocol inception, protocol approval, execution of the contract with the clinical research organization) and end (eg, at first site initiation, first patient enrolled, last site initiated, last patient enrolled)?
- Type of trial: Is the study a single dose, single-site, phase I pharmacokinetic study with 15 healthy volunteers or a pivotal phase III trial with 800 patients, 85 sites, and a myriad of secondary endpoints that require additional tests? According to Lamberti and colleagues, the average time from protocol approval to initiation of all sites was 10 months for phase I trials and 16.7 months for phase II or III trials. Oncology studies had the longest start-up timelines, while respiratory studies had the shortest.
- Length of trial: Some studies run for 3 months, others for 3 years. If the start-up costs are the same, then the percentage of the budget spent on start-up will be higher for the shorter study.
- Type of site: The data collected by Lamberti, et al. found that academic institutions and government-funded hospitals or clinics had the longest start-up times (average of 13 months to enroll the first patient), while independent physicians (either individual or group practices) had the shortest timelines (7 to 9 months). The main difference was the amount of time required to reach contract execution (6 to 9 months for the academic/government sites compared with 3 to 4 months for the independent sites).
- Location of site: Start-up timelines vary widely between world regions, ranging from an average of 7.4 months in North America to 16.1 months in Latin America (again, based on the study by Lamberti, et al).
While it seems that there are too many variables to define a single, “ideal” cost (or cost percentage) for study start-up, there is no doubt that pharmaceutical and biotechnology companies are increasingly embracing approaches, technologies, and procedures that streamline study start-up.
For practical advice on improving your start-up processes, view our webcast, The Joys and Woes of Clinical Trial Start-Up: A Global Perspective.