• The Journal of the Institute of Internet, Broadcasting and Communication
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• v.16 no.5
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• pp.205-212
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• 2016

Recently, researches for the integration and standardization of clinical data in the Western medicine and Korean medicine is in progress. If an integration of similar clinical data as well as heterogeneous clinical data is possible based on one standardization, we can able to derive implicit medical knowledge from integrated clinical data. In this paper, we implemented Korean clinical database based on internationally known CDISC standardization to efficiently store Korean clinical data and constructed E-CRF system for convenient data input in clinical sites. Furthermore, we showed example of an integration of Korean clinical data from 4 clinical sites. The results of our study will help to establish the foundation for the extraction of implicit medical knowledge from integrated clinical data. Also, our results may support efficient management through data integration, prevention of repetitive or unnecessary clinical trials, facilitation of collaborative study and convenient research through the distribution of refined clinical data.

• The Journal of the Korea Contents Association
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• v.11 no.1
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• pp.350-356
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• 2011

The purpose of this study is to empirically examine how much the electronic clinical trial data management system actually enhances its efficiency. While the development of clinical trial markets highlights the significance of data management with increasing rate of adoption of electronic systems, its effects have not been fully supported with rigorous evidences. Particularly, the adoption rate of electronic clinical trial systems is low in domestic clinical trials markets. This study attempts to analyze the effect of the systems for reminding the importance of e-data management in clinical trials. The measurement indicator is experimented with the time related data collected from a multi-center clinical trial case. The result showed that the speed of the electronic clinical trial processes can be improved. The implication of this study lies in its first attempt to empirically analyze the effect of electronic clinical data management systems. Furthermore, application of the indicator in conjunction with electronic clinical trial processes is expected to facilitate strategic data management.

• Journal of Internet Computing and Services
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• v.13 no.1
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• pp.45-55
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• 2012

Electronic data management is getting important to reduce overall cost and run-time of clinical data management with the enhancement of data quality. It also critically needs to meet regulated guidelines for the overall quality and safety of electronic clinical trials. The purpose of this paper is to develop the performance evaluation framework in electronic clinical data management. Four key metrics in the area of infrastructure, intellectual preparation, study implementation and study completion covering major aspects of clinical trial processes are proposed. The performance measures evaluate the extent of regulation compliance, data quality, cost and efficiency of electronic data management process. They also provide measurement indicators for each evaluation items. Based on the key metrics, the performance evaluation framework is developed in three major areas involved in clinical data management - clinical site, monitoring and data coordinating center. As of the initial attempt how to evaluate the extent of electronic data management in clinical trials by Delphi survey, further empirical studies are planned and recommended.

• The Journal of the Korean dental association
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• v.53 no.7
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• pp.476-484
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• 2015

Purpose: This study intended to analyze the validity of clinical effectiveness data of clinical trials testing systemic titrated extract of Zea Mays L. unsaponifiable fraction chemotherapeutic agent. Material and Methods: Among 5 clinical trials claimed as proof of clinical effectiveness on the Web site of the manufacturer of this chemotherapeutic agent, a review of 4 clinical trials, written in either Korean or English, was conducted. Data were extracted from studies for the following variables: year of publication, age, sample size, follow-up period, combination with contemporary periodontal treatments, randomization, randomization check, blinded measurement, and statistical test type. Results: The study subjects' age intervals were too diverse to decide a common target population to generalize the findings. No study stated clearly the rationale for the sample size determination. Follow-up period to observe the start of clinical effectiveness was inconsistent and decided without any rationale of pathophysiological latent period. Randomization to make the comparisons on the same start line was performed but failed in a study. Randomization effect was not checked in 4 studies. Performance of blinded measurement of clinical outcomes to prevent bias was unclear in 2 studies. Type of statistical test was inappropriate in 3 studies. Conclusions: Based on the analysis of the validity of data on clinical and demographic variables, the four available clinical trials have not demonstrated compelling evidence of therapeutic effectiveness of systemic titrated extract of Zea Mays L. unsaponifiable fraction chemotherapeutic agent to improve prognosis of periodontal disease either with the contemporary periodontal treatment or without it.

• Journal of Gastric Cancer
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• v.18 no.1
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• pp.1-19
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• 2018

Gastric cancer (GC) is the second leading cause of cancer mortality and the fourth most commonly diagnosed malignant diseases. While continued efforts have been focused on GC treatment, the introduction of trastuzumab marked the beginning of a new era of target-specific treatments. Considering the diversity of mutations in GC, satisfactory results obtained from various target-specific therapies were expected, yet most of them were unsuccessful in controlled clinical trials. There are several possible reasons underlying the failures, including the absence of patient selection depending on validated predictive biomarkers, the inappropriate combination of drugs, and tumor heterogeneity. In contrast to targeted agents, immuno-oncologic agents are designed to regulate and boost immunity, are not target-specific, and may overcome tumor heterogeneity. With the successful establishment of predictive biomarkers, including Epstein-Barr virus pattern, microsatellite instability status, and programmed death-ligand 1 (PD-L1) expression, as well as ideal combination regimens, a new frontier in the immuno-oncology of GC treatment is on the horizon. Since the field of immuno-oncology has witnessed innovative, practice-changing successes in other cancer types, several trials on GC are ongoing. Among immuno-oncologic therapies, immune checkpoint inhibitors are the mainstay of clinical trials performed on GC. In this article, we review target-specific agents currently used in clinics or are undergoing clinical trials, and highlight the future clinical application of immuno-oncologic agents in inoperable GC.

• Journal of Science and Technology Studies
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• v.18 no.3
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• pp.1-45
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• 2018

South Korea has recently emerged as one of the leading countries conducting clinical trials. Seoul, for instance, is now ranked at the top of the list among the cities in the world. This paper examines the rapid growth of research involving human subjects in Korea, not just from the economic perspective (e.g., the growth of global pharmaceutical markets and the subsequent increase in the demand for clinical trials), but from the policy perspective (e.g., the government?s drive to support and promote this field as a new industry). The industrialization of clinical trials in Korea has manifested itself in the rise of international Contract Research Organizations (CRO) doing their business in Korea. They are, figuratively speaking, invited to Korea by the government. This paper intends to uncover and discuss the bioethical issues concerning research on human subjects, the issues that tend to be set aside merely as procedural ones like ??workable documents??. To this end, it investigates the practice of clinical trials by collecting hitherto unherad voices from patient-volunteers, physician-researchers, CRO employees, and government officials. This paper also explores the themes of ??ethical variability?? and ??biocapital?? in order to compare and constrast the case in Korea with those in other countries.

• IMMUNE NETWORK
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• v.22 no.5
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• pp.37.1-37.16
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• 2022

Autoimmune diseases are caused by a dysfunction of the acquired immune system. In a subset of autoimmune diseases, B cells escaping immune tolerance present autoantigen and produce cytokines and/or autoantibodies, resulting in systemic or organ-specific autoimmunity. Therefore, B cell depletion with monoclonal Abs targeting B cell lineage markers is standard care therapy for several B cell-mediated autoimmune disorders. In the last 5 years, genetically-engineered cellular immunotherapies targeting B cells have shown superior efficacy and long-term remission of B cell malignancies compared to historical clinical outcomes using B cell depletion with monoclonal Ab therapies. This has raised interest in understanding whether similar durable remission could be achieved with use of genetically-engineered cell therapies for autoimmunity. This review will focus on current human clinical trials using engineered cell therapies for B cell-associated autoimmune diseases.

• The Journal of Pediatrics of Korean Medicine
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• v.33 no.1
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• pp.58-77
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• 2019

Objectives The purpose of this study is to investigate clinical studies on the effect of acupuncture, moxibustion, and manual therapy in pediatric growth by analyzing randomized controlled trials conducted in China. Methods We searched the clinical studies from the China Academic Journal (CAJ) in China National Knowledge Infrastructure (CNKI) by specific key words and criteria. Selected 31 clinical studies were collected and analyzed. Results Total of 31 randomized controlled trials were selected and analyzed. In most of the studies, the effectiveness of acupuncture, moxibustion, and manual therapy on growth was significantly high. The most commonly used therapies were massage. The most commonly used massage methods were pinching spine (捏脊), pressing and kneading $Z\acute{u}s\bar{a}nl\check{i}$ (按?足三里), supplementing $P\acute{i}j\bar{i}ng$ (補脾經), supplementing $Sh\grave{e}nj\bar{i}ng$ (補腎經), rubbing Abdomen (摩腹), pushing $Y\check{o}ngqu\acute{a}n$ (推涌泉), supplementing $F\grave{e}ij\bar{i}ng$ (補肺經), kneading $T\grave{a}iy\acute{a}ng$ (?太陽), and kneading $Sh\acute{e}nqu\grave{e}$ (?神闕) etc. Conclusions Based on the results of the clinical studies from China, acupuncture, moxibustion, and manual therapy can be a valuable option for pediatric growth.

• The Korean Journal of Applied Statistics
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• v.11 no.2
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• pp.269-285
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• 1998

One of the most important issues in the area of clinical trial research is the determination of the sample size required to insure a specified power in detecting a real or clinically relevant difference of a stated magnitude. Increasingly, medical journals are requiring authors to provide information on the sample size needed to detect a given difference. We restrict our attention to the designs far comparirng two survival distributions. These are concerned with the survival time which is defined as the interval from a baseline(e.g. randomization) to failure (e.g. death, recurrence of disease). Survival times axe right censored when patients have not foiled by the time of analysis or have been loss to follow-up during the trial. For different types of clinical trials for comparing survival distributions, there have been marry research in sample size determination. We review the existing literature concerning commonly used sample size formulae in the design of randomized clinical trials, and compare the assumption, the power and the sample size calculation of these methods. We also compare by simulation the expected power and observed power of each method under various circumstances. As a result, guidelines in terms of practical usage are provided.

• IMMUNE NETWORK
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• v.21 no.1
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• pp.4.1-4.18
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• 2021

The global outbreak of coronavirus disease 2019 (COVID-19) is still threatening human health, economy, and social life worldwide. As a counteraction for this devastating disease, a number of vaccines are being developed with unprecedented speed combined with new technologies. As COVID-19 vaccines are being developed in the absence of a licensed human coronavirus vaccine, there remain further questions regarding the long-term efficacy and safety of the vaccines, as well as immunological mechanisms in depth. This review article discusses the current status of COVID-19 vaccine development, mainly focusing on antigen design, clinical trials in later stages, and immunological considerations for further study.