ISR Report Shows Increase in Adoption, Momentum for Adaptive Clinical Trial Designs

ISR Report Shows Increase in Adoption, Momentum for Adaptive Clinical Trial Designs

Industry Standard ResearchAndrew Schafer, 919-301-0106

(ISR) today launched a new market research report titled “” providing clinical operations and regulatory professionals with new insights into the industry’s adoption and use of adaptive trials.

“Rising clinical trial costs and the continued high failure rates in Phase III have forced pharmaceutical companies to reevaluate how they conduct their clinical development,” explained Andrew Schafer, President of ISR. “Pharma is looking across their entire R&D process for ways to improve outcomes and adaptive trial designs are definitely in the mix, as we’ve seen an increase in the adoption of adaptive trials since ISR last examined the topic in 2010.”

ISR’s new adaptive trial report is based on a survey of 102 pharmaceutical decision-makers who have experience with adaptive trials. The report analyzes the current market dynamics, including the levels of adoption, the types of studies being conducted, the reasons why these trials are gaining momentum, the major drivers for adoption, and the barriers that decision makers are likely to face when instituting adaptive design strategies.

“ISR found that 91% of respondents indicated adaptive trials are gaining momentum within their organizations,” Schafer explained. “Respondents indicated their companies are implementing these strategies to reach ‘go/no go decisions’ faster and hoping that adaptive trials will increase the likelihood of identifying the correct dosage to move forward with into Phase III trials.”

The report also examines the outsourcing environment surrounding adaptive clinical trials by analyzing the current level of outsourcing penetration, quantifying sponsors’ comfort level associated with outsourcing adaptive activities, as well as identifying criteria sponsors use to identify and select service providers.

“When conducting a clinical development study with an adaptive design, sponsors are more comfortable outsourcing the clinical operations component compared to the statistical design component,” Schafer explained. “One component that sponsors remain unlikely to outsource is regulatory planning.”

Industry Standard Research is the premier, full service market research provider to the pharma and pharma services industries. With over a decade of experience, ISR delivers an unmatched level of domain expertise. For more information about ISR’s off-the-shelf intelligence and custom research offerings, please visit the company’s Web site at , email , or follow us on Twitter @ISRreports.