SOURCE: Cutting Edge Information

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July 19, 2017 19:23 ET

Clinical Teams From Top Pharma Companies Are Overcoming Challenges in Planning and Implementing Adaptive Trial Design Studies

RESEARCH TRIANGLE PARK, NC--(Marketwired - July 19, 2017) - A recent study of Top 10, Top 50, and small medical device companies found that addressing regulators' concerns for late-stage studies is the most common challenge clinical development teams encounter during their adaptive trial design preparations, according to research published by business intelligence firm Cutting Edge Information.

Regarding adaptive trial implementation, data from the study, Adaptive Design Clinical Trials: Strategically Modify Traditional Methodologies to Support Efficient Clinical Operations, found that ensuring the probability of statistical bias (including type 1 and type 2 errors) does not exceed the FDA-mandated margin of error (5%) remains challenging for clinical teams.

"Pharmaceutical, medical device and biotech teams conducting adaptive design studies face multiple planning and execution challenges," says Adam Bianchi, senior director of research at Cutting Edge Information. "To overcome these concerns, clinical teams may begin to anticipate regulatory agency perspectives, establish additional protocol provisions for maintaining data integrity, or demonstrate company experience with adaptive trial designs."

Clinical teams should consider regulatory agencies' perspectives on strategic adaptive trial design use as part of their clinical trial planning activities, Cutting Edge Information's study found. As part of its rationale, the FDA notes that compared with late-stage studies, early-stage research has less bearing on regulatory approval.

By enforcing additional protocol provisions to uphold data integrity, clinical teams may be able to reduce statistical interference and maintain operational consistency as the trial progresses. Clearly designed clinical protocols can alleviate many adaptive trial design challenges and are more likely to yield informative findings.

Previous individual or company experience with adaptive trial design may increase the teams' odds of receiving approval, one Top 10 company executive notes. This level of caution is understandable considering that one large-scale clinical trial failure could have dire consequences, beyond the scope of research and development programs -- particularly for small and biotech organizations.

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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