121 – Minimizing Bias in Medical Device Trials Through Study Design and Data Analysis
Minimizing Bias in Observational Comparative Clinical Studies
Lilly Q. Yue
U.S. Food and Drug Administration
Although well-controlled and conducted randomized clinical trials are viewed as gold standard in the safety and effectiveness evaluation of medical products, including drugs, biological products and medical devices, observational (non-randomized) comparative studies play an important role in the medical product evaluation, due to ethical or practical reasons, in both pre-market and post-market regulatory settings. However, various biases could be introduced at every stage and into every aspect of the observational study, and adversely impact the interpretation of the study results. Among existing statistical techniques for addressing some of the bias issues, propensity score methodology is one increasingly used in regulatory settings, due to its unique future of separating "study design" and "outcome analysis". In this presentation, we will focus on the propensity score approaches in minimizing bias in medical device studies through adequate study design and data analysis.