Status of Awareness and Use of Real-World Data and Real-World Evidence in the Domestic Drug Approval Process: Insights from the Survey Study

Objective: Real-World Data (RWD) and Real-World Evidence (RWE) complement the limitations of clinical trials and play a crucial role in drug development and approval processes.This study assesses the awareness of RWD/RWE in the Korean drug approval process, and investigates practical experiences and challenges.Methods: The survey collected 113 responses through both offline and online methods.The respondents were broadly classified into two groups: those utilizing it for academic purposes and those for profitgeneration purposes.Data were analyzed using SAS 9.4 software.Results: Data revealed that only 26% of respondents felt they could fully utilize RWD/RWE currently, while 40% believed they could do so within 1 2 years.Both groups recognized the importance of RWD/RWE, but there were significant differences in utilization perceptions.80% of academic respondents positively evaluated RWD/RWE, while 48% of respondents from the pharmaceutical industry indicated that more time was needed (p-value=0.011).In academia, the proportion of those with and without RWD/RWE experts was similar.However, the pharmaceutical industry showed 1.75 times higher rate of lacking such experts (p-value=0.173).Major challenges identified included data accessibility and quality issues, with the industry particularly concerned about costs.Among those without plans to utilize RWD/RWE, the main obstacles cited were the absence of experts within research teams and inadequate laws and regulations.Conclusion: This study highlights the necessity of addressing data accessibility and quality issues, training specialized experts, and providing clear regulatory guidelines and support.Bridging the perception gap between academia and the industry requires solutions to improve data accessibility and reduce cost burdens.Regulatory agencies should strengthen the legal framework for RWD/RWE utilization and establish systems and guidelines to ensure data quality and consistency.By systematically investigating the awareness and utilization of RWD/RWE in the domestic drug approval process, this study identifies key barriers and proposes solutions to overcome them.Effective utilization of RWD/RWE is expected to significantly enhance the efficiency and safety of drug development and approval processes, driving innovation.(