WorldCare Clinical, Inc. Publishes Guidance on Defining the Process for Independent Endpoint Review Services in Clinical Trials

Published: Dec 10, 2012

BOSTON, MA--(Marketwire - December 10, 2012) -

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A 'Second Opinion' for Subjective Endpoints: The Case for an Endpoint Assessment Committee

WorldCare Clinical (WCC), a leading CRO focused on maximizing the precision and accuracy of independent assessments in clinical trials, has in collaboration with Dr. Sheela Agarwal, Massachusetts General Hospital (MGH), Division of Abdominal & Interventional Radiology, published a review article entitled "US FDA Draft Guidance Standard for Clinical Trial Imaging Endpoints: More Than Just Imaging?" in the December issue of Biomarkers in Medicine. The lead author of the article, WCC President Dr. Richard Walovitch, will also present on the content at the CBI Bio/Pharmaceutical Imaging Forum on December 11th in Philadelphia, PA.

Independent endpoint assessment committees are increasingly being requested by regulatory agencies to decrease bias in interpretation of subjective endpoints in many different therapeutic areas. Although no FDA guidelines regarding the general process for performing these assessments currently exist, WCC has developed a process found acceptable by the FDA in multiple therapeutic areas. WCC's review article and associated presentation provide guidance on how to perform independent review for trials with subjective endpoints specifically. Dr. Walovitch's presentation, entitled "FDA Draft Guidance for Clinical Trial Imaging Endpoint and the Blinded Independent Central Review (BICR)" will take place at 4:45 p.m. on Tuesday, December 11th.

Independent endpoint assessments require access to research clinicians across a wide range of therapeutic areas, including radiology, pathology, oncology, and many others. "Our long-standing strategic relationship with MGH allows us to draw from the best subspecialty-trained, board-certified experts, who are trained by WCC under a uniform system to maximize the precision and accuracy of data interpretation," said Dr. Walovitch.

About WorldCare Clinical
WorldCare Clinical (WCC) is a leading imaging CRO that employs imaging expertise, innovative technology and operational excellence to maximize the precision and accuracy of a blinded independent central review of clinical trial data. Originally founded in 1992 by the Massachusetts General Hospital (MGH) Department of Radiology, WCC has evolved as an independent company while maintaining a strategic relationship with MGH. With a 20-year focus on imaging trials and their specific requirements, WCC provides sponsors with extensive medical, operational, and image management expertise in support of even the most complex study designs. For more information, visit www.wcclinical.com.