• Korean Journal of Medical Ethics
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• v.21 no.4
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• pp.344-359
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• 2018

The purpose of this study was to identify how patients with chronic kidney disease understand informed consent and related factors for clinical trials. Data from a paper-based survey was collected from July 1, 2017 to April 30, 2018. The subjects for this study were 85 adult patients with chronic kidney disease who were participating in clinical trials. Surveys were conducted by a tool modified from QuIC as designated by Joffe in 2001. The QuIC consists of two parts: objective and subjective cognition. These tools were modified for this study. The average score for the objective understanding (OU) of informed consent for clinical trials was 69.56; the average score for the subjective understanding (SU) of informed consent for clinical trials was 3.28. It was found that health literacy predicted OU (F=27.709, p<.001) while SU was predicted by additional information (F=-3.095, p<.003), question (F=13.603, p<.001), and informed consent (F=-4.833, p<.001). In conclusion, the results of this study indicate that the understanding of informed consent for clinical trials among patients with chronic kidney disease is relatively low. Accordingly, alternative methods that consider each patient's health literacy levels and related factors need to be considered in order to improve their understanding of informed consents during the clinical trial process.

• The Korean Journal of Applied Statistics
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• v.23 no.6
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• pp.1115-1124
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• 2010

Normal approximation methods under the null hypothesis of no difference are frequently used to test the two independent proportions in non-inferiority trials. However, these tests are not appropriate under the null hypothesis of non-zero difference. We review the likelihood score methods proposed by Miettinen and Nurminen, Farrington and Manning, and Gart and Nam and compare the performance of these tests. The simulation study shows that the likelihood score tests under the null hypothesis of non-zero difference have better performance at a Type I error and power than usual normal approximation methods.

• Korean Journal of Oriental Medicine
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• v.8 no.2 s.9
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• pp.37-46
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• 2002

Clinical trials are experimental studies with human subjects in which various limitations and variables exist by their nature. As a preparatory stage for designing clinical trials in Oriental medicine, this study considers a virtual protocol to show guideline regarding tasks necessary when writing a trials protocol. Clinical trials have many difficulties in planning, procedure, and interpretation of results, and these may be influenced by various biases that are difficult to predict and eliminate. To deal with these issues, clinical trials need a collaboration between medical experts and biostatisticians from the beginning, through the entire trial, until the final analysis. Therefore, the first stage of clinical trials is to write out a trial plan among the experts in each field to derive the best design for the trial.

• 대한임상약리학회:학술대회논문집
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• 1995.12a
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• pp.27-27
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• 1995

• 대한임상약리학회:학술대회논문집
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• 1999.12a
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• pp.60-60
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• 1999

• 대한임상약리학회:학술대회논문집
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• 1998.12a
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• pp.46-46
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• 1998

• 대한임상약리학회:학술대회논문집
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• 1998.12a
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• pp.20-20
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• 1998

• Communications for Statistical Applications and Methods
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• v.16 no.1
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• pp.51-65
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• 2009

The purpose of a phase I clinical trial is to determine the maximum tolerated dose(MTD) of a new drug. This paper investigates the performance of standard method, continual reassessment method and accelerated titration designs in phase I clinical trials. Especially we study the precision and safety at the MTD of these methods. We utilize hyperbolic tangent function and power function to define dose-toxicity model. For each method, expected toxicity rate at MTD is computed and compared with target toxicity probability. We also suggest some modifications of these methods and show some improvements in performance.

• Journal of Pharmacopuncture
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• v.11 no.4
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• pp.101-105
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• 2008

여기서는 보완대체의학의 임상효능을 평가하기 위한 일반적인 연구원칙들을 제시하였다. 어떻게 우리가 보완대체의학을 평가할 것인가? 그것이 정말 통상의학과 다른가? 우리는 보완대체의학을 통상의학과 비교하여 우리의 연구 질문들을 다르게 제시해야만 하는가? 보완대체의학은 안전하고 경제적인가? 그리고 우리가 이러한 전문적인 이슈들을 어떻게 제시할 것인가? 보완대체의학 연구는 관심을 가진 임상가들에게 지적인 도전을 제시 한다. 과학적으로 평가하는 것은 가능하긴 하지만 어렵다. 특정 약물치료를 통한 무작위대조 임상시험들은 침술, 동종요법, 수기요법과 같은 유사한 분야의 학문들보다 계획하고 투여하는 것이 훨씬 쉽다. 보완대체의학 분야에서 임상연구의 전술과 전략들은 개념상의 연속되는 도전들을 제시할 것이다.

• 대한임상약리학회:학술대회논문집
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• 2001.12a
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• pp.58-59
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• 2001