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Monitoring Progress

Data monitoring committees (DMCs) are frequently used to oversee accruing data from large, pivotal double blind clinical trials where the objective is to demonstrate safety and efficacy. The various roles of the DMCs are often not fully understood or appreciated. DMCs serve two primary functions: to ensure the ethics of the clinical trial, and to provide assurance that basic objectives of the trial have a reasonable likelihood of success.

The ethical mandate is to ensure that patients are not put at undue risk by their participation in the clinical trial. Ensuring patient safety is the primary responsibility of a DMC. A DMC monitors safety outcomes as the trial is ongoing and provides a mechanism to quickly react to any untoward safety events.

The assurance objective is to use DMCs to oversee and monitor the general trial progress. These large trials represent a significant commitment of time and resources, and a DMC provides a means of monitoring essential design elements of the trial in a way that preserves credibility while providing the company with assurance that at the trial’s conclusion the basic objectives have a reasonably high likelihood of being achieved. In this capacity, the DMC can provide important feedback regarding design parameters, such as emerging trends showing lower than anticipated efficacy, unacceptable risk/benefit, or unanticipated trends in the control arm which could result in insufficient power to detect clinical efficacy.


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Ron Kershner received his PhD in biostatistics from Cornell University and has worked in the areas of biostatistics and data management in the pharmaceutical industry for over 25 years. He has worked for large pharma, biotech and clinical research organisations. Currently, Ron is Vice President of Biostatistics and Data Management at AAIPharma Inc. Through his career, Ron has participated in 24 NDA submissions and has served in various capacities in over 20 DMCs. Most recently, Ron served as Chairman of a DMC, providing efficacy and safety oversight for two Phase III studies in kidney transplantation.
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Ron Kershner
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