BOSTON, MA, October 29, 2013 – WorldCare Clinical (WCC), a leading CRO focused on maximizing the precision and accuracy of independent assessments in clinical trials, today announced a new peer-reviewed article entitled, “Subjective Endpoints in Clinical Trials: the Case for Blinded Independent Review.” The article, which was written in collaboration with Drs. Glenn Bubley, associate professor of medicine at Harvard Medical School and director of the genitourinary oncology at Beth Israel Deaconess Medical Center, and Bin Yao, director of biostatistics at Amgen, was published in the September 24 issue of Open Access Journal of Clinical Trials.
“This review article and its companion video abstract is a multidisciplinary overview and process map derived from over ten years of experience conducting complex Endpoint Assessment Committee (EAC) and adjudication services,” stated the lead author of the article, WCC President Dr. Richard Walovitch. “In discussing EAC services with multiple sponsors, it was clear to WCC that there is a lack of consensus on how to perform an EAC. WCC hopes that its review article will act as a resource and provide some initial guidance.”
Independent EACs and clinical event committees are increasingly being requested by regulatory agencies to decrease bias in the interpretation of subjective endpoints in many different therapeutic areas. Although no FDA guidelines for performing these assessments currently exist, WCC’s EAC trial designs have been found acceptable by regulatory agencies and have passed an FDA audit.
“The publication outlines a relatively novel and innovative approach for endpoint assessments in multi-center clinical trials. This approach adds accuracy and rapid analysis with potential cost savings; and therefore should be helpful for the assessment of future studies,” stated Dr. Glenn Bubley, senior author of the manuscript.
By maintaining a relationship with Harvard teaching hospitals, WCC is able to draw from the best subspecialty-trained, board-certified practicing physicians. From radiology and dermatology to oncology, cardiology and neurology, WCC provides blinded independent central reviews (BICR) by experts that are trained by WCC under a uniform system to maximize the precision and accuracy of data interpretation.
About WorldCare Clinical
WorldCare Clinical (WCC) is a leading imaging CRO that employs clinical expertise, innovative technology and operational excellence to maximize the precision and accuracy of a blinded independent central review (BICR) 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.
For more information on WCC’s services call (888) 816-4721 or visit us on our new website worldcareclinical.com.