Per-patient clinical trial costs have risen an average 70 percent across all development phases since 2008. The report, “Clinical Operations: Benchmarking Per-Patient Costs, Staffing and Adaptive Design,” tracks per-patient clinical trial cost benchmarks for 100 trials across multiple therapeutic areas. Cutting Edge Information compared new data with research going back to 2008 and found that Phase I per-patient costs increased by an average 46 percent and Phase II costs increased an average 72 percent.
But the largest increases in per-patient costs came in Phase IIIa and Phase IIIb, which saw an average 88 percent and 86 percent rise, respectively. The study found that both Phase IIIa and Phase IIIb per-patient costs now top $40,000 compared to approximately $25,000 three years ago. Phase IV (post-marketing studies) costs also rose, but at a more modest 31 percent, on average.
The most significant factor for increased clinical trial costs is patient recruitment. This comes as no surprise because clinical development teams have struggled to enroll sufficient volunteers to fill trials for several years now. But other factors, such as site recruitment challenges and vendor management, also play a big part in the rising costs we now see.
While finding a sufficient number of general clinical sites is a challenge, the biggest driver behind higher vendor costs and site recruitment issues is an increasingly intense competition for top-performing investigator sites. An increase in the number of trials across almost all therapeutic areas means that more companies are competing for the most reliable and best-staffed sites, leading to greater demand and higher costs.
Likewise, finding CROs and sites that are not recruiting against themselves by hosting several similar studies is proving challenging, and thereby expensive, according to many surveyed executives.
“Clinical Operations: Benchmarking Per-Patient Costs, Staffing and Adaptive Design,” (http://www.cuttingedgeinfo.com/research/clinical-development/trial-operations/) contains clinical performance metrics, including trial budgets and key performance indicators. The study provides 26 key metrics of clinical trial performance as well as usage data for adaptive clinical trials. It also provides benchmarking insights for better coordinating in-house staff and vendor teams to hit trial endpoints.