Droice Labs had the opportunity to submit a letter to the FDA on their draft guidance titled Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products (referred to as “Draft Guidance”).

The Draft Guidance recognizes the importance of utilizing real-world data (RWD) for external control arms (ECA) and lays out a vision to use RWD in clinical trials. Droice shares FDA’s values of transparency, reproducibility, and good scientific practices when using RWD for regulatory decisions. As scientists and researchers, we believe that conducting ECA studies in a transparent, scientifically rigorous manner is critical for generating valid and trustworthy results. We thus applaud the Draft Guidance’s emphasis on the principles of sound scientific methods for ECAs across the study lifecycle, from selecting an appropriate data source to the final analysis.

Here are some of the things we request in our letter to the FDA to emphasize in the Draft Guidance: 

• Importance of collecting and reporting metadata, including data lineage, to ensure transparency and mitigate biases. Suggestions for storing and reporting revised study definitions along with appropriate validation metrics, assessment of impact on the study, and justification that the revised definition would not favor particular study results.

• Challenges in providing patient-level source data and suggestions for utilizing metadata and lineage to ensure auditability and reproducibility, especially in cases where source data cannot be provided directly. Recommendations for addressing challenges in using CDMs for RWD, including capturing data loss and ensuring reliability through element-level lineage and metadata.

Read our full comments here.

Droice Labs’ mission is to reduce the size and duration of clinical trials by using real-world evidence (RWE). Our technologies scalably convert raw, messy real-world patient data (RWD) collected in routine care (e.g. EHRs, labs, claims etc.) into high quality, reliable data for biopharma clinical trials as per FDA guidance. 

Explore how you can partner with Droice to solve the scalability and data reliability issues and leverage RWD to accelerate clinical trials.