Foundation Formed to Improve Data Quality in Clinical Trials

FOUNDATION FORMED TO ESTABLISH SUPERIOR METHODOLOGIES
FOR IMPROVING DATA QUALITY IN CLINICAL TRIALS

Leading CNS experts gather to improve ratings precision and reduce error variance

Southeastern, PA – August 25, 2008.   The Foundation for Improving Data Quality (FIDQ) recently held its first meeting in Washington, DC, to outline future efforts to refine methodologies that increase the precision of subjective endpoints used in clinical trials.  FIDQ’s mission is to generate evidence through objective, non-partisan, applied research for the purpose of improving the validity, accuracy and reliability of the measurement of subjective clinical outcomes in psychopharmacology and other disease areas.  The Foundation’s ultimate goal is to lead to stronger success rates of those clinical trials that rely on subjective assessments as pivotal endpoints.

The FIDQ is governed by a Council of leading central nervous system (CNS) research experts who have been selected for their specific areas of expertise in psychiatry and neurology.  Serving as Chairman is Amir Kalali, MD, Vice President, Medical and Scientific Services, Global Therapeutic Group Leader CNS, Quintiles Transnational Corporation.  According to Dr. Kalali, “There is a great need for taking clinical trial methodology in CNS research to the next level. We are optimistic that these research initiatives will help define superior data collection and assessment methodologies in such disease areas as psychiatry, neurology and pain which are dependent upon subjective endpoints.”

The scientific leaders serving with Dr. Kalali on the Council are Peter Buckley, MD (Department of Psychiatry, Medical College of Georgia); Jeffrey Cummings, MD (David Geffen School of Medicine at UCLA); David Daniel, MD (United BioSource Corporation); John Greist, MD (Madison Institute of Medicine, University of Wisconsin and Healthcare Technology Systems); Philip Harvey, PhD (Emory University School of Medicine); Mark Rapaport, MD (David Geffen School of Medicine at UCLA, Cedars-Sinai Medical Center); and David Sheehan, MD (University of Southern Florida).
 
The need to establish concise methodologies for research initiatives within CNS studies is widely understood among researchers.  Dr. Greist explained: “The subjective nature of clinician-rated and patient-reported outcomes is associated with relatively high error variance in measurement, as compared to objective, physiologic measures. This, in turn, may contribute to the high failure rate of clinical trials where reliance on non-physiologic endpoints for establishing efficacy is used.  By perfecting the precision of subjective measures, we hope to enhance statistical power and reduce sample size, while improving signal detection within clinical trials.”

The FIDQ will meet regularly to discuss new developments and plan future efforts. “Systematic development of reliable, valid and novel signal detection methodologies is paramount for the FIDQ.  There is a great need for such an undertaking in clinical research,” said Dr. Daniel. “The commitment to the advancement of evidenced-based clinical trial methodologies is core to the FIDQ and I am excited to be part of such an impressive team.”
 
The Foundation for Improving Data Quality is located in Southeastern, PA. For more information, visit www.fidq.org <http://www.fidq.org/>.