Webinar: The Impact of Clinical Trial Design on Outcomes of Chronic Pain Studies

Date: February 12, 2014

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The epidemic of failed clinical trials of analgesics known to be efficacious has prompted first a soul searching, then a search for evidence, on how specific aspects of clinical trial design and conduct can influence outcomes. Nathaniel Katz, MD, MS, President, Analgesic Solutions will present emerging data on:

▶ The relationship between the patients' ability to report pain accurately and study outcome
▶ The impact of a specific program to reduce placebo effects on patient expectation of treatment benefit (which is the main driver of the placebo response)
▶ The impact of the number of clinical research sites on the study outcome
▶ A bedside method for subtyping patients based on putative pain mechanism
▶ A new approach to differentiating analgesics based on an integrated risk-benefit composite measure

The presentation will conclude with recommendations on what research sponsors can do to take advantage of these findings to reduce risk of failure of analgesic studies, followed by a question and answer session.

Dr. Katz is President of Analgesic Solutions, a consulting firm focused on analgesics. Dr. Katz is also Adjunct Assistant Professor of Anesthesia at Tufts University School of Medicine. After completing his neurology residency at Tufts-New England Medical Center he entered a Pain Management fellowship in the Department of Anesthesia at Brigham & Women's Hospital in 1990. After which Dr. Katz was appointed Staff Neurologist in the Pain Management Center of Brigham & Women's Hospital. Subsequently, he founded the Pain & Symptom Management Program at Dana Farber Cancer Institute, and the Pain Trials Center (a clinical analgesics research unit) at Brigham & Women's Hospital. He remained Director of both until 2001. From 2000-2004 Dr. Katz served as Chair of the Advisory Committee, Anesthesia, Critical Care, and Addiction Products Division, United States Food and Drug Administration, during which time he completed a Master of Science degree in Biostatistics at Columbia University.

Dr. Katz's interests include clinical research methods, analgesic clinical trials, opioids for chronic pain, opioids and addiction, neuropathic pain, and cancer pain. He has completed numerous clinical trials of treatments for pain, both industry-initiated and investigator-initiated, involving pharmaceuticals, non-pharmaceutical analgesics and devices, and has also conducted studies related to opioids, pain, addiction, and other issues related to opioid therapy. Dr. Katz is active on many publications and was an Associate Editor at the Clinical Journal of Pain, and Associate Editor (Pain) for the Encyclopedia of Neurological Sciences, and has overseen many local and national educational programs on pain management.