Running A Better Clinical Trial

February 26, 2009 Ron Marks, Ph.D. Chief Scientific Officer Clinipace

Is this necessary? www.clinipace.com © 2003-2009 Clinipace, Inc. All Rights Reserved. Pharmaceutical Research and Manufacturers of America, Pharmaceutical Industry Profile 2008 (Washington, DC: PhRMA, March 2008). Regulatory Analysis Operations Design

Be design “intelligent” ,[object Object],[object Object],[object Object],[object Object],[object Object],www.clinipace.com © 2003-2009 Clinipace, Inc. All Rights Reserved. Consider Most data collected is never used…Furthermore, some data are collected excessively or in an inefficient manner. [ Dr. Gwendolyn Fyfe, senior staff scientist ,Genentech] ,[object Object],[object Object],[object Object],[object Object],[object Object]

Power it right ,[object Object],[object Object],[object Object],www.clinipace.com © 2003-2009 Clinipace, Inc. All Rights Reserved. I can tell within 15 minutes of reading a statistical plan if it will succeed. [ Dr. Blair Keagy, UNC School of Medicine]

Listen to the FDA ,[object Object],[object Object],[object Object],www.clinipace.com © 2003-2009 Clinipace, Inc. All Rights Reserved. Red Flags There is no prescribed monitoring frequency. [Robert J. Temple, M.D., Associate Director for Medical Policy, Center for Drug Evaluation and Research, FDA] ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Don’t over rely on a CRO ,[object Object],[object Object],[object Object],[object Object],[object Object],www.clinipace.com © 2003-2009 Clinipace, Inc. All Rights Reserved. Consider ,[object Object],[object Object],[object Object],[object Object]

Running A Better Clinical Trial

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Running A Better Clinical Trial