SOURCE: Cutting Edge Information

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March 27, 2017 19:28 ET

Surveyed Top 50 Pharma and Biotech Companies Report Average Per-Patient Costs of $57,500 During Non-Adaptive Phase 1 Studies

RESEARCH TRIANGLE PARK, NC--(Marketwired - March 27, 2017) - Surveyed pharmaceutical, biotech, and device companies expend up to $120,000 per patient during Phase 1 non-adaptive studies, according to recent data published by business intelligence firm Cutting Edge Information. Comparing survey responses for Phase 1 adaptive design clinical trials shows that companies typically expect to spend no more than $80,000 per patient.

The data published in Adaptive Design Clinical Trials: Strategically Modify Traditional Methodologies to Support Efficient Clinical Operations show that most surveyed clinical development teams were relatively consistent when budgeting for adaptive and non-adaptive research. Survey respondents expect to pay more per patient for complex adaptive elements than designs that require only limited adjustments to existing trial protocols.

For example, during Phase 1, one small pharmaceutical company expects to pay $8,000 per patient for adaptive dose-finding trial designs -- but up to $11,000 per-patient for biomarker-adaptive studies. Moreover, many surveyed companies expect to pay more per patient once adaptive and non-adaptive studies alike progress beyond Phase 1.

"Companies using adaptive trial designs may do so in an effort to identify effective products faster and to shorten clinical trials," said Sarah Ray, senior research analyst at Cutting Edge Information. "While investing in adaptive trials may help conserve research and development costs in the long run, the use of complex, planned adaptions during clinical trials may require a slightly higher investment up front."

A Top 50 pharmaceutical company expects to pay an additional $10,000 per patient when conducting Phase 1 drop-the-loser adaptive trials versus traditional Phase 1 studies. This Top 50 company also estimates that use of drop-the-loser adaptive study designs can potentially conserve up to 10 months of planned study time.

However, other survey teams -- including one biotech company -- expect to spend the same amount per patient ($70,000) for adaptive and non-adaptive oncology trials. Another biotech company spends an average of $100,000 per patient during Phase 1 studies, and for Phase 1 oncology studies with adaptive trial design elements, the team reports spending even less: $80,000 per patient.

Adaptive Design Clinical Trials: Strategically Modify Traditional Methodologies to Support Efficient Clinical Operations, available at, details the time- and cost-savings metrics associated with adaptive design clinical trials. This report covers the industry's use of adaptive trial design including organizational structures, resources and uses of adaptive designs across specific trial development stages and therapeutic areas.

The study also includes:

  • Cost-per-patient benchmarks for early- and late-stage adaptive and non-adaptive trials.
  • Metrics tracking cross-functional involvement in adaptive trial design.
  • Ratios of adaptive vs. non-adaptive clinical studies across 11 therapeutic areas.
  • Real-world profiles illustrating how life sciences teams are using adaptive design.
  • Analysis of adaptive trial design planning and execution challenges and solutions.

To see a list of Cutting Edge Information's clinical development industry research studies, please visit:

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