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한국 제약업계의 실사용데이터 활용 현황 및 발전 방향에 대한 설문조사 연구
조해린(Haerin Cho), 임은선(Eunsun Lim), 박수빈(Suvin Park), 조혜인(Haein Cho), 고하나(Hana Go), 조민정(Minjung Cho), 최남경(Nam-Kyong Choi) 한국보건사회약료경영학회 2023 한국보건사회약료경영학회지 Vol.11 No.1
Backgrounds: Real-world data (RWD) are drawing ever-increasing attention in the pharmaceutical industry. We survey to understand the current status of RWD utilization and gather opinions on improving its usage. Methods: We surveyed RWD utilization related to pharmaceutical companies' conducting and planning RWD studies. A survey was distributed to 181 members of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association and 47 members of the Korean Research-based Pharma Industry Association on November 10, 2021. The questionnaire consisted of closedended and open-ended questions and was divided into three main parts: 1) experience of RWD studies, 2) plan of RWD studies, and 3) future of RWD development. Results: A total of 16 replies were received. Five of the respondents (31.2%) reported having experience conducting RWD studies, and eleven of the respondents (68.8%) reported having a plan for RWD studies. Most companies (81.3%) responded that no experts or departments were in charge of using RWD. Among them, 93.7% indicated that needed an education program to foster experts conducting RWD studies. Opinions on RWD utilization included resolving legal issues, expanding RWD acceptance by regulatory agencies, revising related regulations, and securing professional personnel. Conclusion: Although the low response rate, this study is meaningful in that only those currently interested in using RWD who are aware of the challenges responded. The survey indicates that most pharmaceutical companies have little experience conducting RWD studies but plan to conduct RWD studies. Therefore, we suggest establishing relevant guidelines for using RWD and nurturing infrastructures that can professionally handle RWD.
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사람유두종 바이러스 백신 미접종 관련 요인: 미국 국민건강영양조사 자료를 이용한 단면연구
김민주 ( Min-ju Kim ),임은선 ( Eunsun Lim ),박상신 ( Sangshin Park ),최남경 ( Nam-kyong Choi ) 한국보건정보통계학회(구 한국보건통계학회) 2021 보건정보통계학회지 Vol.46 No.1
The purpose of this study was to investigate the human papillomavirus (HPV) vaccination proportion and the factors associated with HPV non-vaccination according to the characteristics of Americans. Methods: The 2015-2018 National Health and Nutrition Survey (NHANES) data were ana lyzed. The subjects aged 9 to 26 were divided into subgroups according to age and sex. Results: The meaningful variables influencing HPV vaccination included birth country, health insurance, hepatitis A vaccine, hepatitis B vaccine, routine place to go for healthcare and times receive healthcare last year. The factors associated with HPV non-vaccination were income, hepatitis A vaccine, hepatitis B vaccine and times receive healthcare last year. Conclusions: This study was based on a survey of Americans, so the factors associated with HPV non-vaccination may differ from those of Koreans.
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정나영 ( Na-young Jeong ),박상신 ( Sangshin Park ),임은선 ( Eunsun Lim ),최남경 ( Nam-kyong Choi ) 한국보건정보통계학회(구 한국보건통계학회) 2019 한국보건정보통계학회지 Vol.44 No.4
Vaccines require higher safety standards than most other medicinal products because they are given to healthy individuals, including infants, children, and elderly. Despite various activities by national agencies, public concern about vaccine safety often arises. Post-marketing activities for vaccine safety can be broadly classified into passive and active surveillances. Many countries as well as Korea operate passive vaccine safety surveillance systems that report adverse events related to vaccines. However, the active surveillance systems operate only in several countries, such as the United States of Amer ica (USA), Europe, Canada and Australia. In the US, Vaccine Safety Datalink (VSD) and Post-Licensure Rapid Immunization Safety Monitoring (PRISM) were developed in 1990 and 2009 respectively for monitoring vaccine actively. In the case of Europe, the Vaccine Adverse Event Surveillance and Communica tion (VAESCO) consortium was launched in 2008. After the end of VAESCO, the Accelerated Development of VAccine beNefit-risk Collaboration in Europe (ADVANCE) was organized to establish a vaccine benefit-risk monitoring framework in 2013. Canada has been operating a vaccine active monitoring sys tem known as the Canadian Immunization Monitoring Program, ACTive (IMPACT) since 1991. The objective of this review was to describe and compare background, databases, and analysis systems of various vaccine active surveillance systems in the US, Europe, and Canada. We described the examples of studies on the safety of influenza A (H1N1) vaccines carried out in each system. This review could help provide directions for the future development of the ideal active vaccine safety surveillance system in Korea.
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점액성 위선암과 비점액성 위선암 및 위반지세포암종의 임상적 비교
안홍근 ( Honggeun Ahn ),정우철 ( Woo Chul Chung ),김연지 ( Yeon-ji Kim ),유성열 ( Seongyul Ryu ),임은선 ( Eunsun Lim ) 대한소화기학회 2020 대한소화기학회지 Vol.76 No.6
Background/Aims: This study examined the clinical features and prognosis of patients with mucinous gastric carcinoma (MGC), non-mucinous gastric carcinoma (NMGC), and signet ring cell gastric carcinoma (SRC). Methods: A retrospective cohort study was performed, enrolling 65 patients with MGC from January 2007 to December 2016. During the same period, 1,814 patients with histologically proven gastric cancers underwent curative or palliative operations. One hundred and ninety-five NMGC patients were selected as the 1:3 age- and sex-matched control groups. In addition, 200 SRC patients were identified. This study evaluated the demographic features of the patients, pathologic features of the tumor, and the predictive factors, such as the recurrence-free survival and overall survival. Results: The recurrence rates were significantly high in MGC than in NMGC or SRC (both p<0.01). The proportion of early gastric cancer was lower in the MGC group than in the other groups (p<0.01). In addition, metastatic lymph nodes were found more frequently in the MGC group (p<0.01), and the proportion of initial pT4, M1 stage, was highest in the MGC group. The recurrence- free survival and overall survival in the MGC group were significantly lower than those in the NMGC or SRC. Subgroup analysis showed that patients with the same American Joint Committee on Cancer (AJCC) stage of each cancer group showed a similar prognosis. Conclusions: MGC frequently presents an advanced stage with an unfavorable prognosis compared to NMGC or SRC. On the other hand, MGC of the same AJCC stage had a similar prognosis to NMGC and SRC. (Korean J Gastroenterol 2020;76:297-303)
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