PERCEPTIVE INFORMATICS GLOBAL SURVEY RESULTS SHOW GROWING INDUSTRY INTEREST IN IMPLEMENTING ADAPTIVE TRIAL DESIGNS
Boston, MA, April 25, 2011–Perceptive Informatics, the industry’s leading eClinical solutions provider and a subsidiary of PAREXEL International Corporation (NASDAQ: PRXL), today announced results of a global survey conducted during its recent webinar entitled “Implementing Bayesian Response Adaptive Trials.” The webinar, presented by Perceptive Informatics with Tessella, was attended by over 300 professionals from the biopharmaceutical industry across a broad range of clinical, statistical and regulatory functions. Perceptive polled these professionals about their plans for the implementation of adaptive clinical trial designs.*
The survey results revealed that 80% of respondents are considering the implementation of some type of adaptive design over the next 12 months. Of these respondents, the majority (76%) are considering designs that drop treatment arms at fixed interim analyses. Fewer respondents (24%) expect to implement designs that regularly adjust the randomization ratio throughout the study. This approach is referred to as a response adaptive design.
“Following the FDA draft guidance on adaptive trials, increasing implementation of these designs has helped to alleviate regulatory acceptance concerns within the industry,” said Damian McEntegart, Senior Director of Statistics and Product Support, Perceptive Informatics. “An important requirement 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 the length of timelines. Perceptive Informatics is committed to driving the industry in using eClinical solutions to support complex adaptive trial designs and their associated supply management challenges. We are focused on helping the industry to successfully implement adaptive trials, which can enable better decision-making about compounds and reduce the time between development phases.”
Perceptive Informatics, which has supported the implementation of over 100 adaptive trials, provides interoperable eClinical solutions from its eClinical Suite, including Electronic Data Capture (EDC), Randomization and Trial Supply Management (RTSM) technologies, and Electronic Patient Reported Outcomes (ePRO). The Perceptive eClinical Suite facilitates access to the real-time, consolidated data required in adaptive trial designs. Services provided by Perceptive Informatics experts in the area of adaptive trial design include:
- Study design consultation
- Supplies forecasting and simulation
- Implementation of technologies to manage randomization, trial adaptations and supply inventories
For more information about capabilities from Perceptive to support adaptive trials visit: http://www.perceptive.com/solutions/adaptive-trials/. For more information about Perceptive’s strategic alliance partner Tessella, which provides specialized statistical applications, visit: http://www.smarterclinicaltrials.com/.
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*According to the draft guidance from the U.S. Food and Drug Administration (FDA) “Adaptive Design Clinical Trials for Drugs and Biologics” clinical trials can be designed with adaptive features, such as changes in design or analyses guided by examination of accumulated data at an interim point in the trial, that may make the studies more efficient, more likely to demonstrate an effect of the drug if one exists, or more informative by providing broader dose-response information.
About Perceptive Informatics
Perceptive Informatics, a leading eClinical solutions provider and subsidiary of PAREXEL, is focused on helping customers to accelerate the product development process through innovation. Perceptive enables customers to maximize the benefits of clinical trial technologies by providing flexible software-as-a-service (SaaS) applications and leading technology services. The Perceptive eClinical Suite is built on extensive medical and clinical expertise, as well as a deep understanding of the regulatory environment. The suite includes Randomization and Trial Supply Management (RTSM) technologies, Medical Imaging, Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), and Electronic Patient-Reported Outcomes (ePRO). The Perceptive eClinical Suite blurs the boundaries among systems that traditionally have been used in isolation, resulting in simplified workflow, improved efficiency and enhanced productivity. For more information about the integrated solutions in the Perceptive eClinical Suite visit www.perceptive.com.
About PAREXEL International
PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in 71 locations throughout 52 countries around the world, and has approximately 10,380 employees. For more information about PAREXEL International visit www.PAREXEL.com.
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