Ex) Article Title, Author, Keywords
Ex) Article Title, Author, Keywords
Pharmacoepidemiology and Risk Management 2024; 16(2): 156-171
Published online September 30, 2024 https://doi.org/10.56142/perm.24.0016
Copyright © Korean Society for Pharmacoepidemiology and Risk Management.
Ja Yeon Yuk1*, Se Jung Park1*, Hwa Yeon Ko2, Hi Gin Sung2, Jin Ah Jung3, Ju-Young Shin1,2,4
육자연1*, 박세정1*, 고화연2, 성희진2, 정진아3, 신주영1,2,4
Correspondence to:Ju-Young Shin
School of Pharmacy, Sungkyunkwan University, 2066 Seobu-ro, Jangangu, Suwon 16419, Korea
Tel: +82-31-290-7702
Fax: +82-31-292-8800
E-mail: shin.jy@skku.edu
*The first two authors contributed equally for this work.
This is an Open-Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
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 12 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.
KeywordsReal-World Data, Real-World Evidence, Drug approval, Surveys and questionnaires
