Basic Superiority, Non-inferiority, or Equivalence Trials: How, Why and When
June 7, 2013 - Palo Alto CA US
Areas Covered in the Webinar: Overview and comparison of NI, equivalence, and superiority study objectives and designs. Zeroing in on the specific clinical question to be asked. Choosing the appropriate design to answer the specific clinical question. How to determine the appropriate interval of equivalence or acceptable “margin” of inferiority. Appropriate hypothesis tests and statistical interpretation. (for nonstatisticians) Risk of “BioCreep” and other controversies associated with these alternative approaches. FDA guidance and CONSORT considerations. Who will Benefit: Professionals who will benefit from this webinar include: Clinical Research Professionals Clinical Protocol Developers Clinical Study Managers Regulatory Managers Clinical Studies Directors Biostatisticians Anyone who seeks to design appropriate clinical investigations for supporting anticipated labeling for a new drug or medical device.