Webinar on RWE in Medical Device Trials Featuring FDA Statistician

March 30, 2021

Cytel’s new webinar is now available, featuring insight from former FDA statistician Dr. Ram Tiwari, now Head of Statistical Methodology at Bristol Myers Squibb. Industry-wide trends include utilizing RWD (real world data) and RWE (real world evidence) and the FDA has begun utilizing such data in regulatory decisions. Dr. Tiwari discusses the use of Bayesian methods to generate RWD.

“External data can be used to generate hypotheses to be tested in a prospective clinical study. It is useful in establishing Performance Goal (PG) or Objective Performance Criteria (OPC). External data can also be used as supplementary data to get additional information. And as mentioned earlier, external data is useful in trials to construct or strengthen investigational device arm and/or control arm.” Read more here.

(Source: The Cytel Blog, 3/26/21)


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