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. 2025 Jan 1;131(1):e35528.
doi: 10.1002/cncr.35528. Epub 2024 Aug 28.

Feasibility of structuring electronic health record data to facilitate real-world data research: ICAREdata methods applied to multicenter cancer clinical trials

Suzanne George  1 , Nancy Campbell  2 , Shauna L Hillman  3 , Elizabeth S Harlos  3 , David W J Stein  4 , Miranda Y Chan  4 , Selina L Chow  5 , Cassandra L Elrahi  2 , Andre C Quina  4 , Maeve C Kokolus  4 , Michelle D Casagni  6 , Matthias Weiss  7 , Daniel M Anderson  8 , Walter M Stadler  9 , Olivia C Hoff  8 , Donna R Rivera  10 , Paul G Kluetz  10 , Sumithra J Mandrekar  3 , Steven Piantadosi  11
Affiliations

Feasibility of structuring electronic health record data to facilitate real-world data research: ICAREdata methods applied to multicenter cancer clinical trials

Suzanne George et al. Cancer. .

Abstract

Background: The use of electronic health record (EHR) data for research is limited by a lack of structure and a standard data model. The objective of the ICAREdata (Integrating Clinical Trials and Real-World Endpoints Data) project was to structure key research data elements in EHRs using a minimal Common Oncology Data Elements (mCODE) data model to extract and transmit data.

Methods: The ICAREdata project captured two EHR data elements essential to clinical trials: cancer disease status and treatment plan change. The project was implemented in clinical sites participating in Alliance for Clinical Trials in Oncology trials. Data were extracted from EHRs and sent by secure Fast Healthcare Interoperability Resource messaging (a standard for exchanging EHRs) to a database. Selected elements were compared with corresponding data from the trial's electronic data capture (EDC) system, Medidata Rave.

Results: By December 2023, data were extracted and transmitted from 10 sites for 35 patients, involving 367 clinical encounters across 15 clinical trials. Data through March 2023 demonstrated that concordance for the elements treatment plan change and cancer disease status was 79% and 34%, respectively. When disease evaluation was reported by both EHR and EDC (n = 15), there was 87% agreement on cancer disease status.

Conclusions: Documentation, extraction, and aggregation of structured data elements in EHRs using mCODE and ICAREdata methods is feasible in multi-institutional cancer clinical trials. EDC as a reference data set allowed assessment of the completeness of EHR data capture. Future initiatives will focus on elements with shared definitions in clinical and research environments and efficient workflows.

Plain language summary: Clinical trials use electronic case report forms to report data, and data must be manually entered on these forms, which is costly and time consuming. ICAREdata methods use structured, organized data from clinical trials that can be more easily shared instead having to enter free text into electronic health records.

Keywords: Integrating Clinical Trials and Real‐World Endpoints data (ICAREdata); clinical trials; electronic health record; interoperability; minimal Common Oncology Data Elements (mCODE); structured electronic health record.

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Conflict of interest statement

Suzanne George reports grants from Blueprint Medicines, Daiichi Sankyo, Deciphera Pharmaceuticals, Eisai, IDX, Merck, NewBay, SpringWorks, Thesus, and Tracon; personal/consulting fees from BioAlta, Blueprint Medicines, Deciphera Pharmaceuticals and Kayothera; fees for service on a Data and Safety Monitoring board from Ayala; support for other professional activities from BioAlta, C‐Stone, Immunicum, and UpToDate; and owns stock in Abbott Laboratories outside the submitted work. Walter M. Stadler reports grants/research support (to institution) from AbbVie, Amgen, AstraZeneca, Astellas (Medivation), Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Calithera, Clovis, Corvus, Eisai, Exelixis, Genentech (Roche), Johnson & Johnson (Janssen), Merck, Novartis, Pfizer Inc., Seattle Genetics, X4Pharmaceuticals, and Xencor; personal/consulting fees from AstraZeneca, Aveo, Calico LifeSciences, Caremark/CVS, EMA Wellness, Fortress Biotech Merck, Pfizer Inc., and Xencor; fees for service on a Data Safety and Monitoring Board from Merck Pfizer Canada Inc., Pfizer Inc., and Treadwell Therapeutics; fees as an expert witness from Apotex, DRL, Mylan Inc., and Sandoz Inc.; support for other professional activities from Dava Oncology, Global Academy for Medical Education, OncLive, PeerView, Research to Practice, and Vindico; and stock options in Fortress Biotech outside the submitted work. Sumithra J. Mandrekar reports personal/consulting fees from Flatiron Health and Harbinger Health Inc. outside the submitted work. Steven Piantadosi reports personal fees from CrainiUS and The MITRE Corporation outside the submitted work. The remaining authors disclosed no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Diagram of the mCODE STU‐2 version components (https://hl7.org/fhir/us/mcode/STU2/). CBC indicates complete blood count; CMP, comprehensive metabolic panel; ECOG, Eastern Cooperative Oncology Group; mCODE, minimal Common Oncology Data/ Elements.
FIGURE 2
FIGURE 2
The ICAREdata structured data elements for the cancer disease status (CDS) SmartForm. ICAREdata indicates Integrating Clinical Trials and Real‐World Endpoints data.
FIGURE 3
FIGURE 3
The ICAREdata structured data elements for treatment plan change on the SmartPhrase link in the encounter note. AE indicates adverse event.
FIGURE 4
FIGURE 4
CONSORT diagram for the concordance analysis cohort. CONSORT indicates Consolidated Standards of Reporting Trials; EDC, electronic data capture; pts, patients; Rave, Medidata Rave.
See this image and copyright information in PMC

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