The U.S. Food and Drug Administration (FDA) has a longstanding history of utilizing Real World Data (RWD) and Real World Evidence (RWE) to evaluate the safety and effectiveness of approved, post market phase drugs. Recognizing the increasing accessibility of data and advancements in analysis methodology, the FDA is now actively taking steps to extend the potential of RWD to other phases of drug development and discovery. This shift represents a broader acceptance of the value of RWD in understanding how drugs perform in diverse patient populations and real-world clinical settings.
Following the announcement of a series of draft guidances late last year (available here) and the subsequent increase in the number of RWD study submissions, the FDA is now taking measures to improve review efficiency, starting with oncology indications. The Oncology Center of Excellence and the Reagan-Udall Foundation have collaborated to evaluate and define essential data elements that could serve as a starting point for characterizing the data sources and study design of early RWD study proposals.
The Oncology Quality, Characterization, and Assessment of Real-world Data (QCARD) initiative was created with the aim of facilitating effective communication between study sponsors and protocol reviewers, while improving the quality of proposals. At its core, QCARD establishes the basic elements that study sponsors can consider when assembling submissions for review, as well as the minimum requirements for data sources (Figure 1). It also supports information requests from the oncology review teams and provides actionable feedback on proposed RWD studies to the sponsors.
The development of a standardized approach for the approval of early RWD trials, including the characterization and evaluation of data quality brings numerous benefits. It ensures consistency, reliability, and transparency in the assessment while facilitating decision-making, and promoting interoperability and comparability across studies.
At BC Platforms, we are excited about this news because it aligns with our commitment to integrating and managing diverse clinical data types in Trusted Research Environments. One of our products – BCRQUEST.com – has functionalities that ensure full compliance with the QCARD while supporting the clinical trial sponsors in their dealings with the FDA. We are now actively working on establishing a standardized set of attributes based on the QCARD across our federated partner network. This involves characterizing the data source, standardizing information types and formats, and providing corroborating evidence. Our goal, similar to regulatory bodies like the FDA, is to prioritize patients’ interests and enhance their outcomes through effective management, analysis, and collaboration in the drug discovery and development processes.
Additional details about the Oncology QCARD Initiative can be found on the OCE Real World Evidence (RWE) website HERE. A publication describing the collaboration and methodological approach of the Oncology QCARD Initiative is currently in development.
Sources:
FDA’s Oncology Center of Excellence. 2023. Oncology Quality, Characterization and Assessment of Real-World Data (QCARD) Initiative
Facilitating High-Quality Early RWD Study Proposals in Oncology. Availble online at: https://www.fda.gov/about-fda/oncology-center-excellence/oncology-quality-characterization-and-assessment-real-world-data-qcard-initiative. Last accessed: 05.Jul.2023
Regan-Udall Foundation for the Food and Drug Administration. 2023.The Oncology Quality Characterization, and Assessment of Real-World Data. Available online at: https://reaganudall.org/oncology-quality-characterization-and-assessment-real-world-data . Last accessed 05.Jul.2023
Rivera DR, PG Kluetz. 2023. FDA Voices. Facilitating Review of Real-World Data Studies: The Oncology QCARD Initiative Available online at https://www.fda.gov/news-events/fda-voices/facilitating-review-real-world-data-studies-o
ncology-qcard-initiative Last accessed 05.Jul.2023
Common data elements for early proposals of oncology studies using RWD (Source: FDA’s Oncology Center of Excellence. Available online here: https://www.fda.gov/about-fda/oncology-center-excellence/oncology-quality-characterization-and-assessment-real-world-data-qcard-initiative, Last accessed: 06.Jul.2023
