• Tuberculosis and Respiratory Diseases
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• v.75 no.2
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• pp.47-51
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• 2013

Interstitial lung diseases are heterogeneous entities with diverse clinical presentations. Among them, idiopathic pulmonary fibrosis and connective tissue disease-associated interstitial lung disease are specific categories that pulmonologists are most likely to encounter in the clinical field. Despite the accumulated data from extensive clinical trial and observations, we continue to have many issues which need to be resolved in this field. In this update, we present the review of several articles regarding the clinical presentation, prognosis and treatment of patients with idiopathic pulmonary fibrosis or connective tissue disease-associated interstitial lung disease.

• 대한임상약리학회:학술대회논문집
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• 1999.12a
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• pp.34-34
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• 1999

• 대한임상약리학회:학술대회논문집
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• 1999.12a
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• pp.44-44
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• 1999

• Asian Pacific Journal of Cancer Prevention
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• v.13 no.12
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• pp.6337-6342
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• 2012

Background: Clinical trials on cancer subjects have one of the highest dropout rates. Barriers to recruitment range from patient-related, through institutional-related to staff-related factors. This paper highlights the low response rate and the recruitment barriers faced in our Qigong exercises trial. Materials and Method: The Qigong trial is a three-arm trial with a priori power size of 114 patients for 80% power. The University Malaya Medical Centre database showed a total of 1,933 patients from 2006-2010 and 751 patients met our inclusion criteria. These patients were approached via telephone interview. 131 out of 197 patients attended the trial and the final response rate was 48% (n=95/197). Results: Multiple barriers were identified, and were regrouped as patient-related, clinician-related and/or institutional related. A major consistent barrier was logistic difficulty related to transportation and car parking at the Medical Centre. Conclusions: All clinical trials must pay considerable attention to the recruitment process and it should even be piloted to identify potential barriers and facilitators to reduce attrition rate in trials.

• Journal of Society of Preventive Korean Medicine
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• v.19 no.1
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• pp.61-70
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• 2015

Objective : The aim of this study is to investigate the features of clinical trial which used symptom differentiation on cancer patients Method : Electronic databases including Ovid-Medline, Ovid-EMBASE, and Cochrane library were searched. Search terms incorporating the concepts of cancer, herbal medicine, clinical trial were used. Articles described using symptom differentiation in methods were selected. Results : Twelve studies used symptom differentiation for prescribing herbal medicine to cancer patients. A total of 36 symptom differentiation were used. The kind of the herbal medicines was varied as much as the kind of symptom differentiation. Conclusion : Most of herbal medicines used for cancer patients focused on quality of life or adverse events rather than tumor size. Symptom differentiation and herbal medicine used in selected studies were too diverse to categorize. To use standardized symptom differentiation, symptom differentiation instrument should be developed and reliability test and validity test are needed.

• Journal of the Korean Data and Information Science Society
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• v.23 no.6
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• pp.1085-1091
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• 2012

Phase I clinical trials are designed to identify an appropriate dose; the maximum tolerated dose, which assures safety of a new drug by evaluating the toxicity at each dose-level. The adjusted maximum tolerated dose estimation is presented by stopping rule in phase I clinical trial on this research. The suggested maximum tolerated dose estimation is compared to the standard method3 and NM method using a Monte Carlo simulation study.

• The Korean Journal of Applied Statistics
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• v.32 no.5
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• pp.741-752
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• 2019

The purpose of a Phase I Clinical Trial is to determine the maximum tolerated dose (MTD). MTD is important because it affects subsequent clinical trials; however, the existing method has a problem due to an inadequate dose allocated to patients. In this paper, an MTD estimation method is proposed to complement the problems of the existing MTD estimation method. The suggested method applies the initial acceleration step to the modified continual reassessment method. Monte Carlo Simulation Study is adapted to compare a suggested MTD estimation method with the standard design and the modified continual reassessment method.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.28 no.3
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• pp.48-65
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• 2015

Objectives : The aim of this study is to analyze recent clinical research of the acupuncture for the treatment of tinnitus.Methods : We searched pubmed for foreign journals with the title/abstract 'tinnitus, acupuncture' published in the last 10 years, and for domestic journals we searched NDSL, RISS, KISS, The National Assembly Library, The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology with the same conditions as foreign journals.Results : We selected total 10 papers: 7 RCTs, 1 RCT protocol, 1 clinical trial, 1 Systematic Review. In RCT, all studies showed positive effect, however in comparison with the control groups, only 2 studies showed meaningful effects.Conclusions : Positive effect of the acupuncture on tinnitus is expected, but because of several limits observed in many papers, we can't draw defined conclusions. Further well-designed researches are needed.

• Korean Journal of Clinical Pharmacy
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• v.5 no.2
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• pp.33-49
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• 1995

The purpose of this study is to understand present situation of clinical trials, and evaluate the preparedness of the desiRnated institutions to abide by GCP(Good Clinical Practice) standards during clinical trials. Survey on the status of clinical trials was conducted for the desienated 83 clinical trial hospitals, and response rate was $95.2\%$. The results showed that 39 hospitals have conducted clinical trials to obtain drug manufacturing approval from 1990 to 1994. Most of them were trials on Phase III. Only $46.8\%$ of the institutions had sufficient human resources to perform the clinical trials. Institutions which established IRB(Institutional Review Board) accounted for 41 or $51.9\%$, but those who have a protocol evaluation guideline, or Adverse Drug Reaction(ADR) reporting system were only 12, and 21 Places, respectively. Regarding supervision of the investigational drugs, less than 30 institutions designated pharmacist as a supervisor. In conducting clinical trials, $97.4\%$ of trials had high rates of prior consent of testees, but only part of them-$61.7\%$-gave written consent. The level of conducting GCP is found to be unsatisfactory. Institutions must build the appropriate infrastructure and government must prepare in order to protect testees' rights as well as to ensure validity of the results.

• Communications for Statistical Applications and Methods
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• v.5 no.3
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• pp.707-722
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• 1998

This paper evaluates a new clinical trial designs for low infection rate disease. This type of sparse disease reaction makes the traditional two sample t-test or Wilcoxon rank-sum test inefficient compared to a new test suggested. The new test, which is based solely on the larger changes, is shown to be more effective than existing method by simulation for small samples. However, this test can be shown to be connected to the locally most powerful rank test under certain practical conditions. This design is motivated in testing the treatment effects in periodontal disease research.