SOURCE: Cutting Edge Information

Cutting Edge Information Home

June 07, 2017 16:27 ET

Adaptive Design Trials Emerge As Most Popular Method Used By Pharma Companies to Reduce Phase 3 Failures

RESEARCH TRIANGLE PARK, NC--(Marketwired - June 07, 2017) - About 60% of surveyed life science teams believe that using adaptive design trials in early-stage clinical studies increase the odds of Phase 3 success, according to a recent study by business intelligence provider Cutting Edge Information.

An additional 10% of drug companies strongly agree with the success of implementing adaptive design techniques. However, the study found that 20% of surveyed life science teams were unconvinced either way, and another 10% claimed that using these methods did not reduce Phase 3 failures.

The study, Adaptive Design Clinical Trials: Strategically Modify Traditional Methodologies to Support Efficient Clinical Operations, discusses that trial sponsors' use of adaptive design studies during early development stages may yield multiple benefits that indirectly impact Phase 3 outcomes.

When leveraged appropriately, simple adaptive designs that test for futility may allow companies to scrap clinical trial programs that fail to demonstrate efficacy during analyses. On the other hand, complex adaptive designs may increase companies' knowledge of successful products' efficacy and associated dose-responses, in preparation for late-stage research.

"Some Phase 3 failures are difficult to anticipate," said Sarah Ray, senior research analyst at Cutting Edge Information. "However, others can be prevented through efforts to bring drugs forward from exploratory to confirmatory trials."

In moving drugs from exploratory to confirmatory trials, some clinical teams may shortchange their Phase 1 and Phase 2 clinical studies. By incorporating Phase 2 elements into Phase 1 studies, these clinical teams justify transitioning immediately from Phase 1 to Phase 3. However, according to one surveyed senior director, this rushed approach may generate misleading findings, possibly suggesting that ineffective products work.

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 pharmaceutical 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/.

Image Available: http://www.marketwire.com/library/MwGo/2017/6/5/11G140416/Images/June_7_2017_-_PH221_-_Adaptive_Design_Trials_Emerg-b9550232236f88c784742ca57c4a5213.jpg

Contact Information