PRESS RELEASE NEW YORK, February 27, 2024 (Newswire.com) – Droice Labs met with the Food and Drug Administration’s Real-World Evidence Subcommittee in a listening session held on Feb. 2, 2024. The topic of this session was SuperLineage, a standardized format and approach, developed by Droice, that stores element-level data lineage and traceability to enable trust and reliability in real-world patient data (RWD) for regulatory decision-making.
RWD has massive potential for advancing disease understanding, enhancing clinical trials, and providing core evidence in regulatory decision-making. However, the healthcare industry has not yet overcome the quality and reliability issues of RWD, severely limiting their use in critical applications. The FDA’s real-world evidence (RWE) guidance documents have provided forward-thinking clarity towards reliable RWD, recognizing these challenges and outlining scientifically rigorous requirements that any future solution must meet.
The Droice team began its presentation by illustrating challenges involved in using RWD for regulatory use. 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.
Droice staff presented that its traceability solution, SuperLineage, offers a standardized format to store element-level lineage for patient data that can be generated algorithmically along with the data transformations, facilitating highly scalable assessments of data accuracy and completeness. Also discussed was SuperLineage’s ability to accompany all RWD standards and data models, like OMOP, FHIR, SDTM or custom CDMs.
Droice representatives highlighted SuperLineage case studies during the session, including a project that enables a top pharma company to generate external control arms (ECAs) utilizing data from multiple hospitals across the U.S. and Europe and an initiative with a major U.S. health system for pragmatic clinical trials. Mayur Saxena, CEO of Droice Labs, shared, “The discussion with FDA further supports our belief that RWD has the potential to revolutionize patient care and both the industry and regulators are working towards making it a reality.” The session was attended by FDA representatives from the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
About Droice Labs
Droice Labs is an AI technology firm dedicated to scaling precision processing of real-world data to enable pharma drug development and clinical care research. For more information, please visit https://www.droicelabs.com.
Read the press release here: https://www.newswire.com/news/droice-labs-discusses-superlineage-for-real-world-data-traceability-at-22253482