Perceptive Informatics Survey Results Reveal Top Barriers To Implementing Adaptive Trial Designs
Perceptive Informatics, the industry's leading eClinical solutions provider and a subsidiary of PAREXEL International Corporation, recently 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 the industry in gaining more experience in effectively implementing adaptive trials using technologies to support these complex designs and their associated supply management challenges," said Bill Byrom, Ph.D., Senior Director, Product Strategy, Perceptive Informatics.
Perceptive Informatics, which has supported the implementation of over 100 adaptive trials, provides eClinical solutions, including Electronic Data Capture (EDC), Interactive Voice and Web Response Systems (IVRS/IWRS), and Electronic Patient Reported Outcomes (ePRO), which are important to supporting the consolidated information required in adaptive trial design. 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
- Electronic collection of clinical response data
Perceptive's products and services are complemented by adaptive trial expertise provided by other business units of PAREXEL, including Clinical Research Services, and an established partnership with Cytel. For more information about capabilities from Perceptive to support adaptive trials visit: http://www.perceptive.com/product/ivrs/adaptive-trials.html.
About Perceptive Informatics
Perceptive Informatics, a subsidiary of PAREXEL, is the industry's leading eClinical solutions provider. Perceptive Informatics offers unprecedented access to innovative eClinical technologies and resources, providing clinical trial sponsors, CROs, and other service providers with the benefits of an extensive line of products and services throughout the entire clinical development lifecycle. In August, 2008 Perceptive was joined with ClinPhone plc, and the newly combined organization offers eClinical software and services that increase the efficiency and productivity of clinical research. Perceptive's expansive product portfolio includes Interactive Voice and Web Response Systems (IVRS/IWRS,) Medical Imaging, Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS) and Electronic Patient Reported Outcomes (ePRO) solutions, as well as eClinical systems integration and implementation services. For more information about Perceptive Informatics, visit www.perceptive.com.
About PAREXEL International
PAREXEL International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, medical communications and consulting 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 over 9,180 employees. For more information about PAREXEL International visit www.PAREXEL.com.
SOURCE: Perceptive Informatics