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

Hye Sook Han, Kyoung Eun Lee, Young Ju Suh, Hee Jung Jee, Bum Jun Kim, Hyeong Su Kim, Keun Wook Lee, Min Hee Ryu, Sun Kyung Baek, In Hae Park, Hee Kyung Ahn, Jae Ho Jeong, Min Hwan Kim, Dae Hyung Lee, Siheon Kim, Hyemi Moon, Serim Son, Ji Hye Byun, Dong Sook Kim, Hyonggin AnYeon Hee Park, Dae Young Zang

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Abstract

Background: Electronic medical records (EMRs) have the highest value among real-world data (RWD). The aim of the present study was to propose a data collection framework of EMR-based RWD to evaluate the effectiveness and safety of cancer drugs by conducting a nationwide real-world study based on the Korean Cancer Study Group. Methods: We considered all patients who received ramucirumab plus paclitaxel (RAM/PTX) for gastric cancer and trastuzumab emtansine (T-DM1) for breast cancer at relevant institutions in South Korea. Standard operating procedures for systematic data collection were prospectively developed. Investigator reliability was evaluated using 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 the study period at three institutions randomly selected using the concordance rate between the previously collected data and data collected by an independent investigator. The reliability results of the investigators and collected data were used for revision of the electronic data capture system and site training. Results: Between the starting date of medical insurance coverage and December 2018, a total of 1063 patients at 56 institutions in the RAM/PTX cohort and 824 patients at 60 institutions in the T-DM1 cohort were included. Mean investigator reliability in the RAM/PTX and T-DM1 cohorts was 73.5% and 71.9%, respectively. Mean reliability of collected data in the RAM/PTX and T-DM1 cohort was 90.0% for both cohorts in the first analysis and 89.0% and 84.0% in the second analysis, respectively. Mean missing values of the RAM/PTX and T-DM1 cohorts at the time of simulation of fictional cases and final data analysis decreased from 20.7% to 0.46% and from 18.5% to 0.76%, respectively. Conclusion: 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.

Original languageEnglish
JournalTherapeutic Advances in Medical Oncology
Volume14
DOIs
StatePublished - 2022

Bibliographical note

Funding Information:
This study was conducted by the GC and BC committees of the KCSG with funding from the Health Insurance Review & Assessment Service (HIRA). The study was performed in accordance with Good Clinical Practice guidelines and approved by the IRB of each hospital ( Supplemental Tables 1 and 2 ). The IRBs of all participating institutions waived the requirement for informed consent from patients due to the retrospective nature of the study. This study is registered with ClinicalTrials.gov, with identifiers NCT04192734 (KCSG ST19-16) and NCT04202328 (KCSG BR19-15).

Publisher Copyright:
© The Author(s), 2022.

Keywords

  • cancer drug
  • data collection
  • medical record
  • real-world data
  • relevance
  • reliability

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