63 – Missing Data in Safety Evaluation and Observational Studies
Minimizing Missing Data in the Design of Observational Clinical Studies : A Regulatory Perspective
Sponsor: Biopharmaceutical Section
Keywords: Missing Data, Observational Study, Study Design
Lilly Yue
FDA/CDRH
Substantial amount of missing data is not uncommon in medical product clinical studies, particularly for medical devices, and this creates great challenges in the interpretation of study results. Compared to randomized clinical trials, observational studies may present even more hurdles. To reduce the frequency and minimize the impact of missing data, sufficient attention has to be paid at the study design stage. In this talk, some design issues related to missing data will be discussed and illustrated through examples from medical device pre-market regulatory submissions.