Research shows that the use of electronic medical record (EMRs) have the greatest reliability among real-world data (RWD), but controlling for biases that may affect study outcomes remains challenging. 

In this study, Dr Hye Sook Han, MD Division of Hematology and Medical Oncology, Department of Internal Medicine, Chungbuk National University Hospital, Cheongju, South Korea and colleagues attempted to create a data collection framework of EMR based RWD to assess the effectiveness and safety of oncology drugs by conducting a nationwide real-world study based on Korean Cancer Study Group.

Researchers selected ramucirumab plus paclitaxel (RAM/PTX) and trastuzumab-emtansine (T-DM1), which are currently utilized to treat advanced gastric cancer and breast cancer, respectively, under the national health insurance, and systematically collected EMR-based RWD at relevant institutions in South Korea.

Investigator reliability was assessed utilizing the concordance rate between the recommended input value for representative fictional cases and the input value of each investigator. Reliability of collected data was evaluated twice during study period at three institutions randomly chosen by statisticians utilizing the concordance rate between the previously collected data and data collected by the independent investigator. 

Two statisticians independently examined the same data and compared their results to evaluate the data analysis reproducibility.

The researchers discovered that between the starting date of medical insurance coverage and December 2018, a total of 1,063 patients at 56 institutions in the RAM/PTX cohort and 824 patients at 60 institutions in the T-DM1 cohort were included. 

Average investigator reliability for major case report form (CRF) variables in the RAM/PTX and T-DM1 cohorts was 73.5% and 71.9%, respectively. The most common CRF variable with a concordance rate < 70% between the recommended input value and the input value of each investigator was related to adverse events in both cohorts. Average reliability of collected data for major CRF variables in the RAM/PTX and T-DM1 cohort was 90.0% for both cohorts in the first analysis, and 88.0% and 89.0% in the second analysis, respectively. 

The input data discrepancies between previously collected data and data collected by independent investigators were due to the input for variables that were not sorted and were in textual form in the EMRs (performance status, reason for termination, adverse events, best response or disease progression, and survival data). The clinical trial information includes: NCT04192734 and NCT04202328.

In conclusion, the authors wrote, “This real-world study provides a framework that ensures relevance and reliability of EMR-based RWD for evaluating the effectiveness and safety of cancer drugs. There is a need for a digital healthcare system in which EMR-based RWD can be structured, defined, formatted, and exchanged with an integrated computer system and converted into scientific data.” 

Resource:

Han H, Lee,K, Suh Y, et al.  Data collection framework for electronic medical record-based real-world data to evaluate the effectiveness and safety of cancer drugs: a nationwide real-world study of the Korean Cancer Study Group (KCSG). Abstract presented at: ASCO Annual Meeting; June 3-7, 2022; Chicago, IL, and virtual. Abstract e18759.