Outcomes/Endpoints in Pharmaceutical Clinical Trials
About
Because of the complexity of the functional gastrointestinal disorders, it has been difficult over the years to determine which outcome measures and endpoints should be used in clinical trials of pharmaceutical agents. Some trials have used a global relief measure as a primary endpoint, while others have focused on symptom improvement. This working team conducted a systematic review and meta-analysis of the psychometric and performance characteristics of primary endpoints used in large multi-center therapeutic trials for irritable bowel syndrome using pharmacological approaches.
Publications
Psychometric Evaluation of Patient-Reported Outcomes in Irritable Bowel Syndrome Randomized Controlled Trials: A Rome Foundation Report
Spiegel, B., Camilleri, M., Bolus, R., Andresen, V., Chey, W. D., Fehnel, S. Mangel, A., Talley, N., Whitehead, W. E.
(2009). Gastroenterology, 137(6), 1944-1953.e1943
Abstract
(2009). Gastroenterology, 137(6), 1944-1953.e1943
Abstract
Members of the Working Team
Chair
Mayo Clinic
Rochester, Minnesota
Viola Andresen, MD
Hamburg, Germany
Allen Mangel, MD, PhD
RTI Health Solutions
Research Triangle Park, North Carolina, USA
Roger Bolus, PhD
Department of Medicine, David Geffen School of Medicine at UCLA
UCLA/VA Center for Outcomes Research and Education (CORE)
Los Angeles, California
Brennan Spiegel, MD, MSHS
Department of Medicine
VA Greater Los Angeles Healthcare System
Department of Medicine, David Geffen School of Medicine at UCLA
UCLA/VA Center for Outcomes Research and Education (CORE)
Los Angeles, California
Nicholas Talley, MD, PhD
Mayo Clinic
Jacksonville, Florida
Jacksonville, Florida
Peter Whorwell, MD, FRCP
Gastroenterology Department
Wythenshawe Hospital
Manchester University, Manchester, UK
William Whitehead, PhD
University of North Carolina
Chapel Hill, North Carolina, USA