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  1. Real-World Evidence

Real-World Evidence (RWE) Resources

The table lists Real-World Data and Real-World Evidence-related public resources, including webinars, presentation, and workshops.

Use filters and search box to find resources

Event Title Event Topic
Public Webinar: Considerations for the Design and Conduct of Externally Controlled Drug and Biological Products  4/24/2023 Guidance, Regulatory Considerations
A Framework for Regulatory Use of Real-World Evidence Workshop 9/17/2017 Guidance, Regulatory Considerations, RWD, RWE
Examining the Impact of Real-World Evidence on Medical Product Development: Workshop I: Incentives 9/19/2017 Guidance, Regulatory Considerations, RWD, RWE 
Examining the Impact of Real-World Evidence on Medical Product Development: Workshop II: Practical Approaches 3/6/2018 Guidance, Regulatory Considerations, RWD, RWE
Examining the Impact: Workshop III: Application 7/17/2018 Guidance, Regulatory Considerations, RWD, RWE
Embedded Pragmatic Clinical Trials Workshop 5/16/2018 Guidance, RWD, RWE, RCTs in Clinical Trials, Pragmatic
SBIA Webinar: Framework for FDA's Real-World Evidence Program 3/15/2019 Guidance, Regulatory Considerations, RWD, RWE
DIA 2019 Update on FDA RWE Program 6/25/2019 Guidance, Regulatory Considerations, RWD, RWE
Leveraging RCTs to Generate RWE for Regulatory Purposes 7/11/2019 Guidance, RWD, RWE, RCTs in Clinical Trials, Pragmatic
Developing Real-World Data and Evidence to Support Regulatory Decision-Making 10/3/2019 Guidance, RWD, RWE, RWE Guidance
Webinar 1: Targeted Machine Learning for Causal Inference based on Real World Data- Dr. Mark van der Lann 2/5/2020 Targeted Learning, Demonstration Project, Statistics
Webinar 2: An Introduction to Targeted Maximum Likelihood Estimation of Causal Effects- Dr. Susan Gruber 3/11/2020 Targeted Learning, Demonstration Project, Statistics
Webinar 3: An Introduction to Super Learning 4/8/2020 Targeted Learning, Demonstration Project, Statistics
Webinar 4: Bayesian Additive Regression Trees (BART) for Causual Inference 5/13/2020 Targeted Learning, Demonstration Project, Statistics
Webinar 5: Practical Issues in Targeted Learning-Dr. David Benkeser 6/3/2020 Targeted Learning, Demonstration Project, Statistics
Webinar 6: Causal Inference of Longitudinal Exposures with Marginal Structural Models: An Overview and Application of Longitudinal TMLE- Dr. Mireille Schnitzer 7/22/2020 Targeted Learning, Demonstration Project, Statistics
Establishing a High-Quality RWD Ecosystem 7/13/2020 Guidance, Data Sources, RWD
Webinar 7: Advantages of covariate adjustment in randomized studies with time-to-event endpoints 9/30/2020 Targeted Learning, Demonstration Project, Statistics
Webinar 8: Cross-validated Targeted Maximum Likelihood Estimation (CV-TMLE) 10/21/2020 Targeted Learning, Demonstration Project, Statistics
Webinar 9: Highly Adaptive Lasso (HAL) in Causal Inference 12/9/2020 Targeted Learning, Demonstration Project, Statistics
Evaluating RWE from Observational Studies In Reg Decision-Making: Lessons Learned from Trial Replication Analyses (Day 1) 2/16/2021 Demonstration Project
Evaluating RWE from Observational Studies In Reg Decision-Making: Lessons Learned from Trial Replication Analyses (Day 2) 2/17/2021 Demonstration Project
Webinar 10: Targeted Machine Learning in Action in the ICU 3/24/2021 Targeted Learning, Demonstration Project, Statistics
Webinar 11: Developing a Targeted Learning-Based Statistical Analysis Plan 4/29/2021 Targeted Learning, Demonstration Project, Statistics
Webinar 12: Practical Considerations for Specifying a Super Learner- Rachael Phillips 5/20/2021 Targeted Learning, Demonstration Project, Statistics
Webinar 13: Challenges and Solutions in the Analysis of Cluster Randomized Trials- Dr. Laura Balzer 6/23/2021 Targeted Learning, Demonstration Project, Statistics
Webinar 14: Expert Augmented Machine Learning- Dr. Gilmer Valdes 7/13/2021 Targeted Learning, Demonstration Project, Statistics
Webinar 15: BAA Project to Advance Regulatory Science and Leverage RWE in Regulatory Decision Making- Drs. John Concato and Hana Lee 8/4/2021 Targeted Learning, Demonstration Project, Statistics
Webinar 16: Targeted Learning: Towards a Future Informed by RWE- Dr. Mark van der Laan 9/15/2021 Targeted Learning, Demonstration Project, Statistics
Public Webinar: Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry 11/4/2021 Guidance, Data Sources, RWD
Public Webinar: Data Standards for Drug and Biological Products Containing RWD 12/3/2021 Guidance, Data Sources, Data Standards, RWD
Public Webinar: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products 1/28/2022 Guidance, Data Sources, RWD
Pubic Webinar: Considerations for the Use of RWD and RWE 2/11/2022 Guidance, Regulatory Considerations
An Overview of Targeted Learning: Instructional Video:  Brief 1 of 4 (~3min) 3/21/2022 Targeted Learning, Demonstration Project, Statistics
The Ratio of Bias to Standard Error: The secret behind poor confidence interval coverage: Instructional Video: Brief 2 of 4 (~5 min) 3/21/2022 Targeted Learning, Demonstration Project, Statistics
Why V-Fold Cross Validation: Instructional Video: Brief 3 of 4 (~9 min) 3/21/2022 Targeted Learning, Demonstration Project, Statistics
What is an Influence Curve? Instructional Video: Brief 4 of 4 (~7 min) 3/21/2022 Targeted Learning, Demonstration Project, Statistics
Lessons Learned from Trial Replication Analyses: Findings from the DUPLICATE Demonstration Project 5/10/2022 Demonstration Project
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