As Early-Stage Clinical Trial Costs Rise; Late-Stage Costs Level Off

The past five years have seen a dramatic rise in per-patient clinical
trial costs. Excluding post-marketing trials, costs in each drug
development stage have experienced more than a 60% rise in costs between
2008 and 2013 — with early-stage trials enduring triple-digit growth, a
new Cutting Edge Information study discovered.

There are several market forces affecting changes to pharmaceutical
research and development. Many micro and macroeconomic factors impact clinical
trials. Interviewed executives cited the following three healthcare
trends as driving forces:

• Emphasis on drug safety data

• New demand for health economics and outcomes research (HEOR)

• Shifts toward personalized medicine and orphan drug development

Data from the latest Cutting Edge Information study, “Clinical
Development and Trial Operations: Protocol Design and Cost Per Patient
Benchmarks,” found that costs have nearly doubled in five years, with
the average Phase 3b trial now costing $48,500 per-patient. While
pivotal studies saw a dramatic cost increase between 2008 and 2011, new
data indicate that per-patient
costs in Phase 3 trials have leveled off in 2013.

“Higher trial costs are not only a late-stage phenomenon,” said Ryan
McGuire, research team leader at Cutting Edge Information. “Early-stage
trials have experienced higher cost increases on both a raw dollar and
percentage basis. Phase
1 trial costs experienced the largest increase, rising $23,600 per
patient, or 157% in the past five years. Phase 2 trials were not far
behind, rising 108% during the same time period.”

The study “Clinical Development and Trial Operations: Protocol Design
and Cost Per Patient Benchmarks,” (
operations/) is designed to help clinical operations teams to staff
trials appropriately using key performance indicators, such as patients
per CRA and sites per CRA. As well as create realistic clinical
trial protocols that balance scientific needs and patient needs.

Use this report to:

For more information about CRA staffing and clinical benchmarks, contact
Cassie Demeter at 919-403-6583.

Cutting EdgeCassie Demeter, 919-403-6583

Source: Cutting Edge