Some Challenges in Non-randomized Medical Device Clinical Studies: A Regulatory Perspective
*Lilly Yue, FDA Keywords: Non-randomized, Medical device clinical studies While randomized well-controlled clinical trials has been viewed as the gold standard in the evaluation of medical products, it is not uncommon for medical device clinical studies to depart from the paradigm of randomized trials, due to ethical or practical reasons. In non-randomized studies, the advantages of well designed and conducted randomized clinical trials are no longer available, and then the statistical inference obtained from such studies may have lower level of scientific assurance, compared to those from randomized trials. Apparently, there are many challenges encountered in non-randomized clinical studies in terms of study design and statistical analysis as well as regulatory issues. In this talk, some challenging issues will be discussed and illustrated from a regulatory statistical reviewer’s perspective.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC