| 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 |
