• 대한예방의학회:학술대회논문집
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• 1994.02b
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• pp.297-312
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• 1994

Over the last decade, considerable interest has focused on sample size estimation in the design of clinical trials. The resulting literature is scattered over many textbooks and journals. This paper presents these methods in a single review and comments on their application in practice.

• YAKHAK HOEJI
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• v.55 no.4
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• pp.345-351
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• 2011

Gastritis is the most common disease among Korean. The demand for the development of gastritis drugs has been increasing. Currently, however, there is no guideline available for the clinical evaluation of gastritis drugs worldwide. As a consequence, domestic and international pharmaceutical companies make errors in the drug development processes, and it becomes difficult for them to establish the scientific validity and objectivity of newly developed drugs. The objective of this study was to develop the Guideline for Clinical Trials Evaluation of Gastritis which can be used in improving the quality and consistency of clinical trials. First, we collected and reviewed the clinical trials on gastritis drugs that were available from Japan Pharmaceuticals and Medical Devices Agency and Korea Food and Drug Administration (KFDA), and investigated the recent research trends on clinical trials of gastritis drugs. Reviewers from KFDA and National Institute of Food and Drug Safety Evaluation and scientific experts from the pharmaceutical industries developed the guidelines through regularly scheduled meetings. Opinions and consultation from academic fields and industry experts were also obtained. This project will provide the clinical trial practitioners, investigator and reviewers the scientific and rational guidelines for performance and evaluation of clinical trials for gastritis drugs. Furthermore, we hope this guideline contributes to establishing the national competitiveness, improving the quality of clinical trial, and encouraging researches on drug development for gastritis.

• The Journal of KAIRB
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• v.4 no.2
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• pp.36-41
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• 2022

Purpose: The purpose of this study is to evaluate how university hospital Institutional Review Boards (IRBs) in Korea classify risk when reviewing clinical trial protocols. Methods: IRB experts (IRB chairman, vice chairman, IRB administrator) in the university hospitals obtaining a Human research protection program (HRPP) or IRB accreditation in Korea were asked to fill out the Google Survey from September 1, 2020 to October 10, 2020. Result: Among the 23 responder hospitals, 8 were accredited by the American Association for Human Research Protection Program (AAHRPP) and 8 were accredited by the HRPP of Ministry of Food and Drug Safety (MFDS). Seven were accredited by Forum for Ethical Review Committees in Asia and the Western Pacific or Korea National Institution for Bioethics Policy. Thirteen of 23 hospitals (56.5%) had 4 levels (less than minimal, low, moderate, high risk), 4 hospitals had 3 levels (less than, slightly over, over than minimal risk), 1 hospital had 5 levels (4 levels plus required data safety monitoring board), and 1 hospital had 2 levels (less than, over than minimal risk) risk classification system. Thirteen of 23 hospitals (56.5%) had difficulty classifying the risk levels of research protocols. Fourteen hospitals (60.9%) responded that different standards among hospitals for risk level determination associated with clinical trials will affect the subject protection. Six hospitals (26.1%) responded that it will not. Three hospitals (13.0%) responded that it will affect the beginning of the clinical trial. To resolve differences in standards between hospitals, 14 hospitals (60.9%) responded that either the Korean Association of IRB or MFDS needs to provide a guideline for risk level determination in clinical trials: 5 hospitals (21.7%) responded education for IRB members and researchers is needed; 3 hospitals (13.0%) responded that difference among institutions needs to be acknowledged; and 1 hospital (4.3%) responded that there needs to be communication among IRB, investigator, and sponsor. Conclusion: After conducting a nationwide survey on how IRB in university hospital determines risk during review of clinical trials, it is reasonable to use 4-level risk classification (less than minimal, low, moderate, high risk); the most utilized method among hospitals. Moreover, personal information and conflict of interest associated with clinical trials have to be considered when reviewing clinical trial protocols.

• The Journal of KAIRB
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• v.6 no.1
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• pp.17-31
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• 2024

Purpose: This study aims to develop preliminary items for measuring the perceived service quality of clinical trials among participants and to verify content validity. Methods: This study was designed as a methodological study. A conceptual framework was established based on Brady and Cronin's hierarchical model, and preliminary items were prepared through translation-back-translation, a review of existing instruments, and in-depth interviews with clinical trial participants and clinical research coordinators. The final items were completed through content validity testing by experts and a review of items by clinical trial participants for the prepared preliminary items. Results: Through this study, a set of 58 items across four domains (quality of interaction with researchers, the physical environment, performance procedures, and performance results) and 9 components (information·education·communication, trust, respect for participant preferences, securing facilities and space, accessibility, comfortability, informed consent, coordination of care, subjective understanding of clinical trials) on the service quality of clinical trials were completed. The scale content validity index of all preliminary items was 0.96, meeting the recommended standards. The individual-item content validity index also meets the recommended criteria for most items, excluding four items. Conclusion: This study holds significance in developing items to measure the quality of clinical trial execution from the perspective of participants. By verifying the reliability and validity of these items through subsequent research, it is expected that they can be utilized as a valuable instrument to devise strategies for improving the quality of clinical trials.

• Journal of Acupuncture Research
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• v.32 no.2
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• pp.59-64
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• 2015

Objectives : This study aims to evaluate current clinical evidence of traditional Korean medicine treatment on wrist pain with carpal tunnel syndrome. Methods : Ten Korean databases were searched for prospective clinical trials of traditional Korean medicine therapy on wrist pain with carpal tunnel syndrome from the time of their inception to February, 2015. Studies conducted in Korean, Chinese and English were searched. Risk of bias in included non-randomized controlled trials was assessed by the Cochrane handbook procedure. Results : Four non-randomized controlled trials were included. A high risk of bias was observed in all trials. All of the included studies reported favorable effects being experienced by an intervention group compared to a baseline or control group. Included studies never described any occurrence of adverse events. Conclusions : There is no evidence that traditional Korean medicine treatments are effective for treating wrist pain associated with carpal tunnel syndrome. All of the included studies lacked appropriate methodological qualities and internal validity. Future well-designed clinical trials that evaluate the effects and safety of traditional Korean medicine treatment for patients with carpal tunnel syndrome are needed.

• Korean Journal of Acupuncture
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• v.35 no.2
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• pp.47-55
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• 2018

Objectives: Clinical improvements can be observed following placebo administrations in clinical trials. Randomized controlled trials have been conducted to disentangle the specific effects of therapeutic interventions over the past decade. In acupuncture trials, non-penetrating placebo needles offer the opportunity to determine the specific effects of needling. Methods: The present review provides an overview of the concept of the placebo effect and the characteristics of the placebo needles. Results: Placebo control can contribute to minimize for bias and the contextual and psychological components of therapeutic interventions. Placebo control should meet two criteria: blinding efficacy (indistinguishable from active treatment) and physiological inertness. In the case of acupuncture, however, it is difficult to meet both criteria simultaneously. The dilemma of placebo needles suggests that placebo needles do not constitute proper control in acupuncture research. Considering the characteristics of placebo needles, patients are more likely to perceive placebo needles as active treatment in acupuncture trials compared to placebo pills in pharmaceutical trials. Placebo response might be observed more frequently to placebo needles than to placebo pills. When acupuncture treatments are utilized in clinical use, placebo effects can be enhanced by exploiting patients' expectations in the contextual or environmental cues that surround medical intervention. Conclusions: We have to consider these unique characteristics of placebo needles in order to avoid drawing premature conclusions that acupuncture itself is just a placebo.

• Clinical Nutrition Research
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• v.12 no.1
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• pp.54-64
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• 2023

A systematic review and meta-analysis were designed to summarize studies conducted on the effects of raspberry and blackcurrant consumption on blood pressure (BP). Eligible studies were detected by searching numerous five online databases including PubMed, Scopus, Web of Science, Cochrane Library, and Google Scholar, until December 17, 2022. We pooled the mean difference and its 95% confidence interval (CI) by applying a random-effects model. Overall, the impact of raspberry and blackcurrant on BP was reported in ten randomized controlled trials (RCTs) (420 subjects). Pooled analysis of six clinical trials revealed that raspberry consumption has no significant reduction in systolic blood pressure (SBP) (weighted mean differences [WMDs], -1.42; 95% CI, -3.27 to 0.87; p = 0.224) and diastolic blood pressure (DBP) (WMD, -0.53; 95% CI, -1.77 to 0.71; p = 0.401), in comparison with placebo. Moreover, pooled analysis of four clinical trials indicated that blackcurrant consumption did not reduce SBP (WMD, -1.46; 95% CI, -6.62 to 3.7; p = 0.579), and DBP (WMD, -2.09; 95% CI, -4.38 to 0.20; p = 0.07). Raspberry and blackcurrant consumption elicited no significant reductions in BP. More accurate RCTs are required to clarify the impact of raspberry and blackcurrant intake on BP.

• Journal of Acupuncture Research
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• v.20 no.2
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• pp.18-28
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• 2003

Objective : To research the trends of study related to osteoarthritis with acupuncture in PubMed, and to establish he hereafter direction of acupuncture for osteoarthritis. Methods : We searthed in PubMed, with osteoarthritis and acupuncture limited by abstract, human, English. Results : 1. The pattern of study was as follow: Review article(2), Clinical Trials(13), randomized controlled trials(13). bee venom acupuncture(1), electroacupuncture(1). We further estimated 15 articles. 2. The lesion of osteoarthritis & kinds of acupuncture were as follows: knee(12), hip(2), cervical vertebral(1), bee venom acupuncture(1), electroacupuncture(1). 3. Most clinical trials are related to decrease of pain, functional improvement. 4. 10 of clinical studies provide affirmative result. And they recommend acupuncture for osteoarthritis. 5. 4 of clinical studies provide negative result. And these studies are designed by sham acupuncture method.

• Journal of Ginseng Research
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• v.43 no.3
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• pp.361-367
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• 2019

Panax ginseng, known as Koran ginseng, one of the most commonly used traditional plants, has been demonstrated to show a wide range of pharmacological applications. Ginsenosides are the major active ingredients found in ginseng and are responsible for the biological and pharmacological activities, such as antioxidation, antiinflammation, vasorelaxation, and anticancer actions. Existing studies have mostly focused on identifying and purifying single ginsenosides and investigating pharmacological activities and molecular mechanisms in cells and animal models. However, ginsenoside studies based on clinical trials have been very limited. Therefore, this review aimed to discuss the currently available clinical trials on ginsenosides and provide insights and future directions for developing ginsenosides as efficacious and safe drugs for human disease.

• Journal of Haehwa Medicine
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• v.24 no.1
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• pp.25-36
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• 2015

Objective : This study aims to evaluate a risk of bias by Risk of Bias tool and RoBANS(Risk of Bias Assessment tool for Non-randomized Study) tool for clinical trial papers proving treatment effect of herbs to alopecia and provides the newest reason of effectiveness of herbs to alopecia. Methos : Data were collected through electronic database including NDSL, KISS, KMBASE, Koreantk, OASIS, KoreaMed, KISTI, Pubmd, Cochrane CENTRAL and CINAHL. Two experts in Oriental Medince assessed risk of bias of randomized controlled trials by Cochrane group's Risk of Bias tool and non-randomized controlled trials by RoBANS tool after searching, reviewing and selecting papers. Results : Total number of selected trials is 20 including 4 randomized controlled trials, 13 non-randomized controlled trials and 3 case reports. This study evaluates the risk of bias of 17 papers including 4 randomized controlled trials and 13 non-randomized controlled trials except 3 case reports by risk of bias tool and RoBANS tool. All papers of randomized controlled trials are evaluated unclear for random sequence generation and allocation concealment as there are no word on them. And all papers of non-randomized controlled trials are evaluated unclear for blinding of outcome assessments and relatively low for others. Conclusion : We must try to specify concretely methods of allocation concealment after planning and practicing it for reducing a selection bias in randomized controlled trials. Also report a reason of missing value and blinding outcome assessments. And we have to agonize and mention methods of blinding of researchers for reducing a detection bias in non-randomized controlled trials.