• The Journal of the Convergence on Culture Technology
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• v.4 no.4
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• pp.387-392
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• 2018

Clinical trials are an important part of developing new medical devices or developing new drugs. However, it takes many time and expense to conduct clinical trials. In order to solve this problem, it define the standard format of the data collected in clinical trials in major countries and in Korea. Clinical trials are also underway in korean medicine to develop new medical devices. If it define the standards for the data we collect in clinical trials, there are likely to be a variety of ways to use them. If it collect and manage various clinical trial data as one standardized data, you will be able to draw various results. Based on these findings, we established a system for collecting and managing integrated data on clinical trials. And let's look at how to use it.

• Journal of the Korean Data and Information Science Society
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• v.18 no.2
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• pp.411-418
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• 2007

Sample size calculation is very important in clinical trials. In this paper, we propose sample size calculation method for non-inferiority trials using sample size calculation method suggested by Wang et al.(2003) based on Wilcoxon's rank sum test. Also, sample size comparison between parametric method and proposed method are presented.

• 대한예방의학회:학술대회논문집
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• 1994.02b
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• pp.336-341
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• 1994

Multicenter controlled clinical trials require It synthesis of the scientific method and the precepts of modern management. The management tasks associated with these studies are akin to those found in other kinds of complex corporate endeavors. It is recommended that clinical investigators become more knowledgeable about management concepts and methods and management specialists be given a major role in the planning and conduct of large-scale clinical trials.

• Korean Journal of Biological Psychiatry
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• v.19 no.4
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• pp.153-158
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• 2012

Understanding of a clinical trial is essential in developing clinical guideline and adopting evidence based practice. In designing and executing clinical trials, following ethical requirements should be considered : social value, scientific validity, fair subject selection, informed consent, favorable risk-benefit ratio, institutional review board, and respect for human subjects. According to the stage of drug development, purpose of trials, accumulated scientific data, clinical trials for drug development are classified as phase 1, 2, 3, and 4. Phases of clinical trials can be overlapped and the judgment of entering into the next phase should be considered highly strategically. In reading, evaluating and interpreting clinical trial reports, various skills and challenges exist. Patient sample composition, trial duration, selection of endpoints, responders and non-responders, placebo effect, patient recruitment, and extrapolation to the real world are the examples of those challenges. Treatment success will come from the well balanced approach of evidence based decision making and consideration of specific single case.

• Communications for Statistical Applications and Methods
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• v.5 no.2
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• pp.459-475
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• 1998

In many clinical trials, we are interested in comparing the failure time distribution of different treatment groups. Because of ethical and economic reasons, clinical trials need to be monitored for early dramatic benefits or potential harmful effects. Prior knowledge, evolving knowledge, statistical considerations, medical judgment and ethical principles are all involved in the decision to terminate a trial early, and thus the monitoring is usually carried out by an independent scientific committee. This paper reviews the recently proposed group sequential testing procedures for clinical trials with survival data. Design considerations of such clinical trials are also discussed. This paper compares the characteristics of each of these methods and provides the biostatisticians with the guidelines for choosing the appropriate group sequential methods in a given situation.

• Biomolecules & Therapeutics
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• v.22 no.4
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• pp.267-274
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• 2014

Drug development and preclinical trials are challenging processes and more than 80% to 90% of drug candidates fail to gain approval from the United States Food and Drug Administration. Predictive and efficient tools are required to discover high quality targets and increase the probability of success in the process of new drug development. One such solution to the challenges faced in the development of new drugs and combination therapies is the use of low-cost and experimentally manageable in vivo animal models. Since the 1980's, scientists have been able to genetically modify the mouse genome by removing or replacing a specific gene, which has improved the identification and validation of target genes of interest. Now genetically engineered mouse models (GEMMs) are widely used and have proved to be a powerful tool in drug discovery processes. This review particularly covers recent fascinating technologies for drug discovery and preclinical trials, targeted transgenesis and RNAi mouse, including application and combination of inducible system. Improvements in technologies and the development of new GEMMs are expected to guide future applications of these models to drug discovery and preclinical trials.

• Asian-Australasian Journal of Animal Sciences
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• v.8 no.4
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• pp.387-392
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• 1995

Though a variety of non-conventional feedstuffs have been successfully evaluated in research stations in Asian countries, there had been little adoption of these technologies at the small farm level. The methodology and results of three separate on-farm trials evaluation the possible use of some non-conventional feedstuffs in broiler diets under small farm conditions in Sri Lanka are reported in this paper. In all trials, the commercial mash, that in normally used in the farms, served as the control. In trials 1 and 2, 5 and 10% cassava leaf meal, respectively, was substituted (w/w) for the commercial mash and fed to broilers for six weeks. In trial 3, several non-conventional feedstuffs (cassava leaf meal, rubber seed meal, ipil ipil leaf meal and died poultry manure) were substituted (w/w) for the commercial mash at levels of 15-20%. The results demonstrated that these non-conventional feed resources can be used in broiler diets under small farm conditions, with no adverse effects on performance. The salient features of on-farm animal research are highlighted.

• The Journal of Korean Medicine
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• v.32 no.4
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• pp.128-138
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• 2011

Objective: This study aimed at providing preliminary data useful in reducing participant dropout and improving the quality of clinical trials, by analyzing the factors related to dropout. Methods: The data came from 15 acupuncture and/or moxibustion clinical trials (n=638; August 2005 to December 2009). Logistic regression analysis was used to reveal factors influencing participant dropout. Results: Gender, age, treatment method (intervention), treatment frequency, availability of follow-up, and presence of compensation treatment for the control group were factors influencing participant dropout. Conclusion: Subsequent studies of large-scale acupuncture and moxibustion clinical trials should address dropout factors that consider the character of each clinical trial, or general characters like participants' gender, age, occupation, and diverse diseases.

• Journal of the Korean Data and Information Science Society
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• v.19 no.4
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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.

• Korean Journal of Acupuncture
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• v.25 no.2
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• pp.71-85
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• 2008

Objective : Acupuncture, one of the Oriental medical treatment techniques in East Asia, is growing in popularity all over the world. Based on bibliographical and clinical data, the depth of needling, i.e. superficial or deep needling, has been considered to be a variable as potential modifiers of needling effects, such as localization, manipulation of the needle, or elicitation of DeQi. The purpose of this review is to summarize clinical trials using minimal acupuncture and to evaluate its appropriateness as a control. Methods : A survey of computerized literature searches for randomized controlled trials using minimal acupuncture revealed that a total of 10 studies were published until April 2008. Results : Results obtained from clinical trials showed that acupuncture were more effective than minimal acupuncture in 3 out of 10 trials, while others were no more effective than control. However, minimal acupuncture might neither be a inert placebo nor be indiscriminable. Conclusion : Minimal acupuncture as 'placebo' controls seems misleading and scientifically unacceptable.