Collaborative Program to Evaluate Real World Data for Use in Clinical Studies and Regulatory Decision Making

Meredith N Zozus; Byeong Yeob Choi; Maryam Y Garza; Rhonda Facile; Holly J Lanham; Zhan Wang; Bill Sanns; Muayad Maallah; Henry G Wei; Amy N Cramer; Eric L Eisenstein

Collaborative Program to Evaluate Real World Data for Use in Clinical Studies and Regulatory Decision Making

AMIA Jt Summits Transl Sci Proc. 2023 Jun 16:2023:632-641. eCollection 2023.

Authors

Affiliations

¹ University of Texas Health Science Center San Antonio, San Antonio, TX.
² University of Arkansas for Medical Sciences, Little Rock, AR.
³ Clinical Data Interchange Standards Consortium, Austin, TX.
⁴ Regeneron Pharmaceuticals, Tarrytown, NY.
⁵ Johnson and Johnson, Titusville, NJ.
⁶ Duke University, Durham, NC.

PMID: 37350921
PMCID: PMC10283122

Abstract

The 21^st Century Cures Act allows the US Food and Drug Administration to consider real world data (RWD) for new indications or post approval study requirements. However, there is limited guidance as to the relative quality of different RWD types. The ACE-RWD program will compare the quality of EHR clinical data, EHR billing data, and linked healthcare claims data to traditional clinical trial data collection methods. ACE-RWD is being conducted alongside 5-10 ancillary studies, with five sponsors, across multiple therapeutic areas. Each ancillary study will be conducted after or in parallel with its parent clinical study at a minimum of two clinical sites. Although not required, it is anticipated that EHR clinical and EHR billing data will be obtained via EHR-to-eCRF mechanisms that are based on the Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR®) standard.