SOURCE: Cutting Edge Information

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May 11, 2017 20:00 ET

Study Finds Variations in Percentage of Clinical Teams Using Adaptive Trials and When

RESEARCH TRIANGLE PARK, NC--(Marketwired - May 11, 2017) - There is no one-size-fits-all approach to strategic adaptive trial design use, according a study published by business intelligence firm Cutting Edge Information.

The study, Adaptive Design Clinical Trials: Strategically Modify Traditional Methodologies to Support Efficient Clinical Operations, found that although 30% of survey participants agreed that use of simple adaptive studies across all drug programs is more beneficial than using complex designs in only a few studies, another 40% of surveyed executives disagree with the statement. The remaining 30% of survey participants remain neutral.

When conducting adaptive trials, one surveyed small pharmaceutical company prefers to concentrate on specific therapeutic areas or development stages. A clinical affairs executive at this company believes that by using adaptive trial design selectively, companies can maximize their returns and avoid overcomplicating their studies. An executive at Top 10 company echoes this sentiment, encouraging sponsor organizations to conduct gap analyses early to identify studies that would be a good fit for adaptive trial designs.

"Some surveyed teams prefer to use futility studies and other simple adaptive designs across their entire drug portfolios," said Sarah Ray, senior research analyst at Cutting Edge Information. "But on the other hand, there are clinical teams that are more selective about which trials contain adaptive trial design elements and do not necessarily concentrate on simple adaptive study designs."

Surveyed pharmaceutical, medical device and biotech teams also have multiple perspectives concerning which development stages are most compatible with both adaptive trials in general and with selected adaptive trial design types. Overall, half of surveyed teams remain neutral regarding whether use of adaptive trial designs is more advantageous during early-stage clinical studies. Another 30% of surveyed teams agree that early development stages provide more benefits and present fewer risks than late-stage studies. Ten percent of surveyed teams strongly agreed that using adaptive trial designs in Phases 1 and 2 provides more benefits and poses less risk than using similar trials in Phase 3.

However, another 10% of surveyed teams disagree that companies are best served using adaptive trial designs during Phases 1 and 2. Potentially, this finding indicates that while convincing regulatory authorities to accept Phase 3 studies remains difficult, it is a challenge that some sponsor organizations feel prepared for.

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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