• Journal of the Korean Data and Information Science Society
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• 제22권3호
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• pp.605-612
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• 2011

In multi-center randomized clinical trial the treatment eect may be changed over centers. It is thus important to investigate the heterogeneity in treatment eect between centers. For this, uncorrelated random-eect models assuming independence between random-eect terms have been often used, which may be a strong assumption. In this paper we propose a correlated frailty modelling approach of investigating such heterogeneity using the hierarchical-likelihood method when the outcome is time-to-event. In particular, we show how to construct a proper prediction interval for frailty, which explores graphically the potential heterogeneity for a treatment-by-center interaction term. The proposed method is illustrated via numerical studies based on data from the design of a multi-center clinical trial.

• 한국데이터정보과학회:학술대회논문집
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• 한국데이터정보과학회 2005년도 춘계학술대회
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• pp.200-201
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• 2005

• Journal of the Korean Data and Information Science Society
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• 제19권4호
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• pp.1429-1440
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• 2008

In a meta-analysis combining the results from different clinical trials, it is important to consider the possible heterogeneity in outcomes between trials. Such variations can be regarded as random effects. Thus, random-effect models such as HGLMs (hierarchical generalized linear models) are very useful. In this paper, we propose a HGLM framework for analyzing the binominal response data which may have variations in the odds-ratios between clinical trials. We also present the prediction intervals for random effects which are in practice useful to investigate the heterogeneity of the trial effects. The proposed method is illustrated with a real-data set on 22 trials about respiratory tract infections. We further demonstrate that an appropriate HGLM can be confirmed via model-selection criteria.

• 대한한방내과학회지
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• 제38권2호
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• pp.201-216
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• 2017

Objective: This research aimed to understand patients' perceptions of Korean medicine treatment for osteoporosis in a clinical trial setting. Methods: Ten patients participating in a clinical trial of a herbal medicine drug for osteoporosis were invited to an interview. Data were collected by in-depth interviews and patient observations. This qualitative study adopted the case study research method, and within-case and cross-case analyses were conducted. Results: A model of the patients' osteoporosis management planning was derived from the study. The results showed that the patients' perceptions of osteoporosis were derived from their knowledge and experience during diagnosis and treatment of the condition. Two groups of patients were recognized: those who overlooked the importance of osteoporosis and those who recognized the importance of osteoporosis. Before making treatment decisions about osteoporosis, the patients evaluated the treatment options and weighed the advantages and disadvantages of each option. When evaluating their treatment, the patients combined their knowledge and experience of Korean and western medicine treatments. Their experience of participating in the clinical trial influenced the management planning of osteoporosis. Two major reasons for low compliance with osteoporosis treatment were ignorance of the disease and insufficient information provided by doctors. Conclusion: The results of this qualitative study pointed to four strategies that could be employed to improve accessibility to Korean medicine treatment for osteoporosis: the dissemination of comprehensive information on osteoporosis in the clinic and mass media, promotion of Korean medicine therapies for osteoporosis, management of clinical trial participants, and insurance coverage for Korean medicine.

• 대한약학회:학술대회논문집
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• 대한약학회 2000년도 춘계총회 및 학술대회
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• pp.221.2-221.2
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• 2000

• 대한한방소아과학회지
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• 제35권2호
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• pp.11-20
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• 2021

Objectives The purpose of the study is to evaluate the safety of the Allium Fistulosum extract in children and its effectiveness in height growth. Methods This study is randomized, double-blind, placebo-controlled trial. The participants are children between the 3rd and 25th percentiles in height, and between the ages of 5 and 12 years. They are randomly assigned to treatment group or control group. The treatment group will take 5 g (1 g as Allium Fistulosum extract) for 24 weeks, 1 time a day. The control group will take the 5 g (0 g as Allium Fistulosum extract) of placebo for 24 weeks, 1 time a day. The primary outcome is change in height, and the secondary outcomes are growth rate, height standard deviations, Insulin-like growth factor-1 (IGF-1), Insulin-like growth factor binding protein-3 (IGFBP-3), IGF1-1/IGFBP-3 ratio, growth hormone, bone age, osteocalcin, and Z-score for growth. Results This protocol has been approved by the institutional review board (IRB) of Daejeon Korean Medicine Hospital of Daejeon University (IRB No. DJDSKH-20-BM-15), and registered in the Clinical Research Information Service (CRIS) (Registry No. KCT0005981). Conclusions This study will provide clinical information about the effectiveness and safety of Allium Fistulosum extract in children for their growth.

• 한방비만학회지
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• 제12권1호
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• pp.48-58
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• 2012

Objectives These prescribing recommendations have been written to guide clinicians on the appropriate use of Bangpungtongseong-san(BT) and Bangkihwangki-tang(BH) in the treatment of obesity. These recommendation are aimed at providing evidence based information concerning diagnosis and management of obesity. Methods We collected all relevant references about treatment effect of BT and BH on obesity in the forms of meta-analysis, systematic review, randomized controlled trial, case-control study, observational study and practice guideline from international and domestic databases and paper journals. We examined treatment effect, side effects, recommendations for dose, indication and contraindication of BT and BH. Results The treatment effect of BT and BH on obesity has been proved through clinical trial. BT is indicated for obese patients (Body mass index, $BMI{\geq}25$) with strong abdomen and a tendency to constipation, BH is indicated for obese patients ($BMI{\geq}25$) with a fair skinned, soft muscled, edematous and sweat easily. Conclusion We wish the information contained in theses recommendations will help clinicians reach a reasonable and beneficial decision with evidence-based results. Further studies are strongly needed to develop better treatment strategies for herbal medicines on obesity.

• 인터넷정보학회논문지
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• 제13권1호
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• pp.45-55
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• 2012

임상시험 전체 소요시간 및 비용의 절감, 임상 데이터 질의 향상을 위해 임상시험 전자자료의 관리가 점차 중요해지고 있다. 또한 임상시험 전자자료 관리는 전자 임상시험의 안정성 및 질을 위해 규정 가이드라인을 준수하는 것이 결정적으로 필요하다. 본 연구는 전자적 시스템을 활용한 임상시험에 있어 데이터 관리의 성과를 평가하기 위한 프레임웍을 개발하고자 한다. 연구의 목적을 위해 임상시험 프로세스에 근거하여 기반능력, 연구설계, 연구진행 및 연구완료 등 네 개의 주요 메트릭을 구성함으로써 데이터 관리의 수준을 측정할 수 있는 성과척도를 도출한다. 이때 각 성과척도의 도출 기준은 임상시험 자체가 지향하는 데이터의 질 향상, 전자자료 관리 프로세스의 비용과 효율성 및 규정 준수 수준 등 네 가지의 관리적 관심을 기준으로 하며, 각 성과척도 별로 전자자료 관리 프로세스 상 실질적으로 측정 가능한 측정지표를 제시한다. 평가 프레임웍은 네 가지의 주요 측정 메트릭에 근거하여, 세 개의 데이터 영역(연구기관, 모니터링, 데이터관리센터) 별로 구성된다. 본 평가 프레임웍의 개발은 전문가 의견 수렴을 통한 델파이 방법론으로 접근한 탐색적 연구로서 향후 실증적 후속 연구를 과제로 남기고 있다.

• 대한한의학회지
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• 제30권6호
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• pp.80-85
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• 2009

Objective: This study aimed to build an overview of randomized clinical controlled trials (RCTs) for chronic fatigue-related symptoms to extract the useful data for management of patients and development of therapeutics using Korean traditional medicine in the future. Methods: All RCT-derived papers for chronic fatigue-related symptoms were collected via PubMed Database. We surveyed elementary information of RCTs such as clinical question, study design, and its quality and results. Results: A total of fifty-three RCTs met these review criteria. Most of the RCTs were performed in Western countries, particularly the UK and USA. The major portion of RCTs focused on chronic fatigue syndrome using immune modulators, psychotherapeutic and anti-depressants. Five RCTs using complementary and alternative medicine, including herbal remedies, showed positive results. Conclusions: Fatigue-related symptoms are a main target of Oriental medicine. This study provides helpful information for planning clinical study of chronic fatigue-related symptoms using traditional Korean medicine.

• 한국임상약학회지
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• 제31권1호
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• pp.53-60
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• 2021

Objective: To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. Methods: We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. Results: All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. Conclusion: All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission. Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.