TORONTO, ON --(Marketwired - July 06, 2016) - On Wednesday, July 20, 2016, Xtalks will host a complimentary webinar featuring MUDr. Alan Kott, Clinical Vice President and Practice Lead of Data Analytics at Bracket and Dr. David Daniel, Senior Vice President and Chief Medical Officer at Bracket, and Professor of Psychiatry at George Washington University as the keynote speakers.
Measurement error and data recording errors (including data fabrication) (Baigent, 2008) are frequent and often non-randomly distributed in clinical trial datasets. Even when accumulated at a single site or a small number of sites their impact may be devastating to the success of a CNS clinical trial. It is therefore critical to identify those sites and raters who are at greatest risk of providing erroneous or otherwise compromised data.
Central statistical monitoring techniques have been shown to successfully identify fraudulent/fabricated data in clinical trials using objective outcomes (Knepper, 2016) but have been less effective in clinical trials using subjective outcome measures such as psychiatric rating scales (O'Kelly, 2004). It is however exactly these 'subjective outcome' trials that are in the greatest need of effective data quality monitoring programs.
Bracket has successfully implemented risk-based data quality monitoring programs (Blinded Data Analytics) in a number of CNS clinical trials across numerous indications. These programs combined near real time central statistical monitoring approaches with comprehensive clinical review and where indicated targeted follow-up with the identified raters/sites. In many of these CNS clinical trials, central statistical monitoring worked in concert with intelligent eCOA and remote audio/video monitoring programs.
In this webinar, the speakers will discuss examples of identified data quality concerns coming from CNS clinical trials and the impact of their presence on study outcomes. They will show that many of the data quality concerns are clustering at a small number of centers and many post-randomization data quality concerns can be predicted by the occurrence of similar concerns in the screening period. The presenters will conclude by demonstrating the positive impact of implementing eCOA and remote audio/video monitoring programs on data quality.
For more information or to register for this free webinar visit: Disruptive Innovations in Data Analytics in CNS Clinical Trials
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.
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