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News Event and Announcement Detail

May 13, 2016

Non-Inferiority Pre-Conference Workshop to be conducted at the 37th Annual SCT Meeting

 

Dr. Nicole Close, President and Principal Biostatistician at EmpiriStat, Inc., is scheduled to co-conduct a Pre-Conference workshop at the Society for Clinical Trials’ (SCT) 37th Annual Meeting at the Fairmount The Queen Elizabeth in Montreal, Quebec, Canada, May 15-18, 2016.


The Annual Meeting of the Society for Clinical Trials is a multidisciplinary program with broad participation. The Meeting brings together the clinical trials community from academia, the pharmaceutical and device industries, government agencies, medical groups and centers and clinical research entities.


Dr. Close will co-teach teach a workshop titled “Overview of Non-Inferiority Studies” on Sunday, May 15, 2016, 1:00 PM – 5:00 PM. This workshop gives an overview of many of the issues faced by those designing, running, analyzing, presenting and interpreting studies aimed at showing that a new therapy is ‘no worse than’ (from a practical point of view) an existing therapy. The course will include scientific and regulatory issues, with examples taken from her US and European experience. Examples of proper implementation and improper application will be given.


Dr. Close emphasized that “our clinical trialists, not just biostatisticians, should understand the purpose and potential benefits of non-inferiority studies and how they differ from equivalence and superiority studies.”  She further explained that “extra difficulties associated with these types of studies, over and above those of superiority studies, including such things as assay sensitivity, choice of control group, choice of population to study/analyze, choice of endpoint and choice of non-inferiority margin, should be known by the larger trial professionals.”


For more information on 37th Annual Meeting of the Society for Clinical Trials, please visit http://www.sctweb.org/.




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