webinar register page

Webinar banner
CBER BEST Seminar Series - Negative controls and p-value calibration in RWE generation
Background: The CBER BEST Initiative Seminar Series is designed to share and discuss recent research of relevance to ongoing and future surveillance activities of CBER regulated products, namely biologics. The series focuses on safety and effectiveness of biologics including vaccines, blood components, blood-derived products, tissues and advanced therapies. The length of each session may vary, and the presenters will be invited from outside FDA. Please see the details below for our upcoming seminar. Anyone can register and join for free.

Topic: Negative controls and p-value calibration in real-world evidence (RWE) generation
Description: Despite our best efforts to adjust for confounding, selection bias, and measurement error through clever epidemiological design, we cannot guarantee our effect estimates produced from real-world data are free from bias. Negative controls, exposure-outcome pairs where we believe there is no causal relationship, can help understand how accurate our study design and data are. By comparing the estimates we produce for our negative controls to the truth (of no causal) effect, we can infer a probability distribution for systematic error in our study. By integrating this expression of uncertainty about systematic error into our statistics, such as p-values, confidence intervals, and critical values when performing sequential testing, we can demonstrably achieve operating characteristics closer to nominal; Our p-values will lead to type-1 errors closer to our alpha, and our confidence intervals will show coverage closer to alpha. OHDSI has developed tools that facilitate the selection of negative controls, include those controls in our study designs, and perform empirical calibration, making these best practices available to everyone.

Speaker: Dr. Martijn Schuemie
Research Fellow @ Janssen Research & Development

Mar 22, 2023 11:00 AM in Eastern Time (US and Canada)

Webinar is over, you cannot register now. If you have any questions, please contact Webinar host: Kristin Kostka.