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Perceptive Informatics Survey Results Reveal Top Barriers to Implementing Adaptive Trial Designs
Date:5/4/2009

BOSTON, May 4 /PRNewswire-FirstCall/ -- Perceptive Informatics, the industry's leading eClinical solutions provider and a subsidiary of PAREXEL International Corporation (Nasdaq: PRXL), today announced the results of a survey conducted during its recent webinar entitled "Optimizing Adaptive Trial Designs: Using Simulation Methodologies to Overcome Challenges." The webinar, conducted by Perceptive Informatics with partner Cytel Inc., a provider of specialized statistical applications, was attended by over 500 professionals from the biopharmaceutical industry, across a broad range of clinical, statistical, and regulatory functions. The survey results identified regulatory acceptance concerns, lack of understanding about new techniques, and ability to rapidly access clinical endpoint data as the top barriers to the implementation of adaptive trials.

Respondents to the survey were able to choose more than one category. Regulatory acceptance concerns were cited by more than 35% of respondents, followed by lack of understanding about new techniques (over 33%) and rapid access to clinical endpoint data (over 28%). Other barriers to implementing adaptive trial designs that were cited by respondents included understanding and implementing complex statistical methodologies as well as difficulties in medication supplies estimation and supply chain management.

"Formal FDA guidance on adaptive trials implementation is expected later this year and should help to alleviate regulatory acceptance concerns. As biopharmaceutical companies focus on making reliable decisions as early as possible in drug development, a growing area for adaptive trials is the ability to include more dose levels in Phase II dose-finding studies without significantly increasing the number of study participants or timeline required. Perceptive is committed to assisting t
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SOURCE PAREXEL International Corporation
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