Current Challenges & Future Considerations – Leveraging the FDA’s External Controls Draft Guidance to Execute Clinical Trials with External Control Arms
Time: 11:35 am
day: Pre-Conference Workshop Day
Details:
Following the guidance on the use of RWD to develop RWE for regulatory decision making, in February the FDA expanded upon this to release the draft guidance ‘Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products’ or the External Controls Draft Guidance. However, although the guidance shines a light upon the potential to use a synthetic control group in clinical trials to demonstrate safety as well as substantial evidence of effectiveness for a new drug, there are still many uncertainties surrounding the applicability of external control arms outside of rare diseases and the ability to utilize regulatory grade data to ensure acceptance by the FDA.
Attend this workshop to learn:
- Statistical Considerations for the Design and Conduct of Externally Controlled Trials
- Highlighting international work currently being done to harmonise guidance and best practices regarding real world data (RWD)
- Reviewing the importance of randomisation as well as statistical assumptions like causal inference and assay sensitivity. Going over considerations for assessing quality and comparability of data, with a particular focus on RWD
- Exploring statistical analysis, such as bias, confounding, and missing data, and how these can affect the interpretation and generalisability of the study results.
- Focusing on the FDA Draft Guidance: “Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products” but will speak to other related guidance's as well.
