SOURCE: Cutting Edge Information

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September 04, 2017 19:16 ET

Study Finds Variations in Percentage of Clinical Teams Using Simple and Complex Adaptive Trial Designs

RESEARCH TRIANGLE PARK, NC--(Marketwired - September 04, 2017) - Recent analysis of clinical development teams show that surveyed clinical teams are divided on whether or not companies should concentrate their use of simple adaptive trial designs within Phases 2 and 3.

The study, Adaptive Design Clinical Trials: Strategically Modify Traditional Methodologies to Support Efficient Clinical Operations, found that half (50%) of surveyed teams agree that companies should use adaptive trial designs for Phase 2 and 3, but another 40% of surveyed clinical development teams remain neutral.

Data collected and analyzed by Cutting Edge Information show that the remaining 10% of surveyed pharmaceutical, medical device and biotech teams indicate that companies should not leverage simple adaptive trial designs primarily within Phases 2 and 3.

Instead, for these teams, less complex study designs may be equally important during earlier clinical development stages.

"There is no one-size-fits-all approach to strategic adaptive trial design use," said Adam Bianchi, senior director of research at Cutting Edge Information. "Adaptive trial designs require careful planning, and depending on design complexity, some pose more risk than others."

When it comes to complex adaptive trial designs, the study found that 70% of surveyed clinical trial sponsors agree that companies using complex adaptive trial designs should focus on early-stage studies.

Adaptive Design Clinical Trials: Strategically Modify Traditional Methodologies to Support Efficient Clinical Operations, available at https://www.cuttingedgeinfo.com/product/adaptive-design-clinical-trials/, 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: https://www.cuttingedgeinfo.com/product-category/clinical-development/.

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