Centralized Adaptive Trial Design Teams Promote Cross-Geography Communication

RESEARCH TRIANGLE PARK, NC–(Marketwired – December 07, 2016) – A recent study released by Cutting Edge Information found that most surveyed clinical trial teams — either global or at the country level — report better cross-geography communication through centralized adaptive trial design decision-making structures. Establishing these centralized structures helps influence active dialogue between global and country-level teams.

Cutting Edge Information’s study, Adaptive Design Clinical Trials: Strategically Modify Traditional Methodologies to Support Efficient Clinical Operations, explained that comparing adaptive trial design structures by company type shows that all company types tend to favor centralized structures. Only one surveyed small pharma team reported a completely decentralized decision-making process around adaptive design trials. However, company type affects the degree of centralization that large and mid-sized companies use. The key difference between centralized and somewhat centralized structures is that in the former, non-global teams do not contribute to clinical strategy development.

When decision making is centralized, global and corporate-level teams develop strategy and country-level teams implement strategy. However, under somewhat centralized decision making processes, global and corporate-level teams develop a strategy and country-level teams have autonomy to modify adaptive trial strategies in-line with specific therapeutic-area or regional needs. Completely decentralized decision making, an uncommon structure, occurs when country-level teams make their own decisions about use of adaptive trial designs, depending on specific trial needs.

“Surveyed top 10 pharma organizations have somewhat centralized clinical operations structures,” said Adam Bianchi, senior director of research at Cutting Edge Information. “In these structures, global teams develop strategy and regional or country-level teams can adjust this strategy to better align with any specific needs they may have.”

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 design trial planning and execution challenges and solutions

For more information about Cutting Edge Information’s clinical development research, visit https://www.cuttingedgeinfo.com.

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Elio Evangelista
Senior Director, Commercialization
Cutting Edge Information