Triple-digit growth in the costs of early-stage studies has been a prime driver of significant inflation in per-patient costs for clinical trials over the last five years, a new US study has found.
Per-patient costs for early-stage trials have risen faster than any other category on both a raw dollar and a percentage basis, points out Cutting Edge Information. “Higher trial costs are not only a late-stage phenomenon” commented research-team leader Ryan McGuire.
The new study, Clinical Development and Trial Operations: Protocol Design and Cost Per Patient Benchmarks, notes that trial costs overall have nearly doubled in five years, with the average Phase 3b trial now running to US$48,500 per patient.
Over the same period, Phase I trial costs ballooned by 157% or US$23,600 per patient. Phase II trials were not far behind, with a per-patient cost increase of 108% between 2008 and 2013.
New data indicate, though, that the cost of Phase III trials has levelled off this year, Cutting Edge Information adds.
Executives interviewed for the study cited three trends as pivotal in pushing up trial costs: an emphasis on providing drug-safety data; new demand for health economics and outcomes research; and shifts towards personalised medicine and orphan-drug development