Phase I and II clinical trial budgets double over past five years due to staffing, patient enrollment
Early phase clinical trial budgets climbed dramatically during the recent five year period, rising 157% from 2008 to 2013, largely due to increased clinical research associate (CRA) costs and higher per patient costs, according to a just-released study by life sciences intelligence firm Cutting Edge Information. Phase II clinical trial costs also doubled during the same time period.
“Early-stage trials have experienced very high cost increases on both a raw dollar and percentage basis,” said Cutting Edge research team leader Ryan McGuire in a statement about the study. “Phase I trial costs experienced the largest increase, rising $23,600 per patient,” said McGuire. “Phase II trials were not far behind, rising 108% during the same time period.”
Based on interviews, Cutting Edge found that staffing, patient enrollment and increased protocol complexity are the primary factors driving growth in phase I clinical trial costs. Executives interviewed cited several healthcare trends also driving costs higher: (1) emphasis on drug safety data; (2) new demand for health economics and outcomes research; and (3) a shift toward personalized medicine and orphan drug development.
In another analysis of early phase clinical cost drivers by market research firm Beroe, staffing accounted for 40% to 45% of the total cost, which includes a dedicated team of nurses, the principal investigator, project managers, sub-investigators, pharmacists, regulatory managers and CRAs.
Beroe also found that operating costs associated with running a clinical pharmacology unit (CPU), patient recruitment, diagnostic equipment and other operating costs have increased substantially. Between 15% and 20% of total clinical trial costs are associated with running a CPU and a similar proportion of the costs are tied to patient recruitment.
Procedural costs, including routine equipment user fees for ECG machines, bed cardiac monitoring devices, lab supplies and general clinical supplies accounted for 10% to 15% of total clinical trial costs, according to Beroe. Electronic solutions used for site and data management accounted for an additional 8% to 10% of total clinical trial costs on average.
Beroe analysts also found that other expenses, including medical writing services, sample storage and clinical monitoring, comprised the remaining 8% to 9%.
“No question that patient recruitment is our biggest challenge at the site level,” said Terry Stubbs, CEO of ActivMed Clinical Trials, a phase I investigative site. “Our costs are driven by the length of time patients stay with us, the protocol procedures performed and patient compensation,” she said. Stubbs added that her company’s phase I trials now require the collection of a much higher volume of data on quality-of-life measures.
Whereas sponsors have experienced large increases in phase I and II clinical trial budgets, Stubbs said that sites have not experienced this growth. “Over the recent five year period,” said Stubbs, “early phase clinical trial sites have not experienced such extremes. We’re seeing more modest 10% increases in overall costs.”
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