Big Ideas

Glenn Bubley, M.D.

November 14, 2013

Dr. Glenn Bubley is the Associate Professor of Medicine at Harvard Medical School, Director of Genitourinary Oncology at Beth Israel Deaconess Medical Center and a 2012 Translational Grant recipient. He collaborated on the recent peer-reviewed article “Subjective Endpoints in Clinical Trials: The Case for Blinded Independent Review,” published in Open Access Journal of Clinical Trials. Bubley’s article distills 10 years of experience with Endpoint Assessment Committee (EAC) work to provide a process map for maximizing the precision and accuracy of independent reviews of clinical trials. According to WorldCare Clinical, primary efficacy and safety endpoints are often subjective assessments made by site personnel conducting trials over broad geographic regions, with different clinical practice settings, all of which may result in a loss of precision and accuracy. EACs offer the potential to increase precision and accuracy of the assessment. “The publication outlines a relatively novel and innovative approach for endpoint assessments in multi-center clinical trials,” stated Dr. Bubley, senior author of the manuscript. “This approach adds accuracy and rapid analysis with potential cost savings and therefore should be helpful for the assessment of future studies.”