Droice Labs met with the Food and Drug Administration’s Real-World Evidence Subcommittee in a listening session to discuss SuperLineage, a standardized format and approach, developed by Droice. SuperLineage stores element-level data lineage and traceability to enable trust and reliability in real-world patient data (RWD) for regulatory decision-making.
Here’s a snippet from the discussion:
RWD sources are notoriously complex and diverse, both in content and structure, and utterly unoptimized for analysis. Typical approaches to generating analysis-ready data from RWD transform and aggregate multiple RWD sources into a common data model (CDM). While CDMs provide significant analytical benefits, the transformation process results in data loss, such that subsequent analyses are not reliable. To meet the reliability requirements, additional information that preserves element-level lineage of patient data from source should accompany transformed data and analysis. During the session, FDA representatives commented on accuracy, completeness, and traceability as critical attributes of RWD regulatory submissions, as described in current FDA guidance documents.
Read the full press release 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.
