Pharmaceutical Approaches to Enhancing RWE Data Collected in Non-Interventional Studies
Author(s)
SOO H. LEE, M.PH., Min-Taek Lee, Ph.D., Bo-Ram Park, Ph.D., Seung-Hee Jeong, Ph.D..
Pfizer Korea, Seoul, Korea, Republic of.
Pfizer Korea, Seoul, Korea, Republic of.
OBJECTIVES: To explore the data protection, integrity, and quality assurance aspects of the real-world data (RWD) collected in the non-interventional study (NIS) in South Korea.
METHODS: The NIS aims to evaluate the burden of Respiratory Syncytial Virus (RSV) infections and associated risk factors in infants and children aged 5 years and younger in South Korea. The NIS collects RWD from medical chart reviews and patient-reported outcomes (surveys) based on 59 patients enrolled from December 2023 to February 2024. The characteristics of the study design were investigated to assess data protection and integrity. Exploratory methods included analyzing characteristics of missing values. Data protection involved encrypting data (e.g., AES-256), anonymizing identifiers, and restricting access to authorized personnel. Data integrity was ensured through validation checks, audit trails, and standardized data collection procedures. The quality of RWD collected from the 59 patients was evaluated by assessing variable-level completeness, the distribution of missing data, and response patterns across multiple categories, ensuring completeness and reliability.
RESULTS: Patient confidentiality was ensured through strict adherence to data protection regulations, with informed consent obtained from parents or legal guardians. Data were anonymized and securely stored in encrypted electronic forms, accessible only to authorized personnel. The accuracy and consistency of data were maintained through standardized protocols and validation processes. The electronic case report form (eCRF) tools ensured accurate data recording and management, with any modifications tracked through audit logs. Data quality checks revealed high completeness (over 95% for key variables) and low missingness, with consistent response distributions across variables. No systematic errors or inconsistencies were identified during validation.
CONCLUSIONS: These findings demonstrate the robustness of the NIS' research quality to develop real world evidence (RWE) suitable for the NIS’ objectives. Generating reliable RWE based on robust RWD is crucial for informing future healthcare strategies and regulatory decision making. ACKNOWLEDGEMENT: NIS (C3671045) funded by Pfizer
METHODS: The NIS aims to evaluate the burden of Respiratory Syncytial Virus (RSV) infections and associated risk factors in infants and children aged 5 years and younger in South Korea. The NIS collects RWD from medical chart reviews and patient-reported outcomes (surveys) based on 59 patients enrolled from December 2023 to February 2024. The characteristics of the study design were investigated to assess data protection and integrity. Exploratory methods included analyzing characteristics of missing values. Data protection involved encrypting data (e.g., AES-256), anonymizing identifiers, and restricting access to authorized personnel. Data integrity was ensured through validation checks, audit trails, and standardized data collection procedures. The quality of RWD collected from the 59 patients was evaluated by assessing variable-level completeness, the distribution of missing data, and response patterns across multiple categories, ensuring completeness and reliability.
RESULTS: Patient confidentiality was ensured through strict adherence to data protection regulations, with informed consent obtained from parents or legal guardians. Data were anonymized and securely stored in encrypted electronic forms, accessible only to authorized personnel. The accuracy and consistency of data were maintained through standardized protocols and validation processes. The electronic case report form (eCRF) tools ensured accurate data recording and management, with any modifications tracked through audit logs. Data quality checks revealed high completeness (over 95% for key variables) and low missingness, with consistent response distributions across variables. No systematic errors or inconsistencies were identified during validation.
CONCLUSIONS: These findings demonstrate the robustness of the NIS' research quality to develop real world evidence (RWE) suitable for the NIS’ objectives. Generating reliable RWE based on robust RWD is crucial for informing future healthcare strategies and regulatory decision making. ACKNOWLEDGEMENT: NIS (C3671045) funded by Pfizer
Conference/Value in Health Info
2025-09, ISPOR Real-World Evidence Summit 2025, Tokyo, Japan
Value in Health Regional, Volume 49S (September 2025)
Code
RWD21
Topic Subcategory
Data Protection, Integrity, & Quality Assurance
Disease
No Additional Disease & Conditions/Specialized Treatment Areas