• Translational and Clinical Pharmacology
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• v.26 no.4
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• pp.172-176
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• 2018

Mandatory registration of clinical trials in public registry can ensure the transparency of clinical trials. Public clinical trial registry of can provide current chronological and geographical distribution of clinical trial throughout the country. We used public clinical trial registry provided by Ministry of Food and Drug Safety to analyze current status of clinical trial from 2014 to 2016 in South Korea. The number of clinical trials in antineoplastic and immunomodulating agents area was the greatest, followed by cardiovascular system and antiinfectives for systemic use as a whole. From 2014 to 2016, overall number of clinical trials decreased while the number of phase I clinical trials increased. Seoul accounted for more than half number of clinical trials in Korea. Supports for clinical trials in non-metropolitan area needs to be considered.

• Journal of the Korean Data and Information Science Society
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• v.14 no.2
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• pp.385-391
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• 2003

A sequence of n Bernoulli trials which violates the constant success probability assumption is termed as "Poisson trials". In this paper, the recurrence formula for the r-th central moment of number of successes with n Poisson trials is derived. Romanovsky's method, based on the differentiation of characteristic function, is used in the derivation of recurrence formula for the central moments of conventional binomial distribution. Romanovsky's method is applied to that of Poisson trials in this paper. Some central moment calculation results are given to compare the central moments of Poisson trials with those of conventional binomial distribution.

• Journal of the Ergonomics Society of Korea
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• v.30 no.3
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• pp.381-387
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• 2011

Objective: The aim of this study was to investigate the maximal grip strength for the combinations of resting time and trial and to provide guideline of resting time for the maximum gripping task associated with the number of trials. Background: Despite many previous researches for the maximal grip strength, few studies have considered the effect of both trials and rest time on the maximum grip strength. Methods: A total of thirty subjects participated in the study. The average of maximum grip strength was measured using JAMAR hydraulic hand dynamometer. The testing position was same as the position recommended by the American Society of Hand Therapists. The between-subject experimental design has been conducted in this study. Trials(1~20 trials) and rest time(2, 3, and 4min) were considered as independent variables, and the maximum grip strength was considered as dependent variable, respectively, in this study. Results: According to the result of the number of trials, the maximal grip strength decreased gradually as the number of trials increased. The ANOVA result showed that the main effect was significant for both resting time(p<.0001) and trial(p<.0001), and the interaction was significant(p<0.0086). Conclusions: The maximal grip strength decreased gradually as the number of trials increased. Thus, basic guideline of resting time was suggested for the number of trials of maximal grip strength tests in this study.

• Journal of the Korean Statistical Society
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• v.6 no.2
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• pp.97-102
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• 1977

For a sequence of Markov dependent Bernoulli trails, asymptotic normality of the number of success runs with length $r \geq 1$ is established, when the number of trials tends to infinity.

• The Journal of Korean Medicine
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• v.31 no.1
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• pp.122-129
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• 2010

Objective: To investigate institutional review boards and approved clinical trials of Oriental medical hospitals in Korea Methods: We e-mailed 16 Oriental medical hospitals a survey consisting of questions that addressed two topics, institutional review boards and the clinical trials they approved. The first part included questions about whether each hospital had an institutional review board, that board's staffing and education, reviews, and expedited reviews. The clinical trials portion covered the number and types of approved clinical trials, treatment methods, whether an investigator or a sponsor initiated the trials, diseases, time frame, and clinical trial fee. Results: We received a response to our e-mail from 14 hospitals, all of which had an institutional review board. The average number of institutional review board members was 13.57. Of these Oriental medical hospitals, 70% and 49% said that they regularly educated their institutional review board staff and clinical trial, investigators, respectively. 79% of the hospitals claimed to conduct regular reviews, and 50% said that they did so monthly. The number of approved clinical trials increased sharply from 11 in 2005 to 102 in 2008. 68% of these clinical trials were randomized, and the most-used treatment methods were herbal medicine (35%) and acupuncture (29%). The most common target diseases were circulatory (19%), urinogenital (14%), and musculoskeletal (13%) disease. Conclusions: Despite the rapid increase in clinical research in oriental medical hospitals, many more efforts including raising IRB quality, varying research diseases and increasing clinical trials in the hospitals located in non-metropolitan area, should be made.

• Journal of Society of Preventive Korean Medicine
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• v.20 no.3
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• pp.93-113
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• 2016

Objectives : The focus of the review was laid on differences in research pertaining to thread embedding acupuncture between domestic and foreign journals. Methods : We collected 53 Korean articles on thread embedding acupuncture study from 4 Korean article searching sites, and 80 foreign articles from Pubmed. We analyzed the number of the theses according to the publication year, study method, journal, and subject. Results : A total number of 134 thread embedding acupuncture articles were categorized as 100 clinical trials, 14 experimental papers, and 19 literature reviews. Of the collected clinical trials, 55 were case studies, 6 were CCTs and 39 were RCTs. The domestic clinical trials were comprised of 36 case studies, 1 CCT, and 2 RCTs, and foreign clinical trials were comprised of 19 case studies, 5 CCTs, and 37 RCTs. Although only 12 of the 39 domestic clinical trials exclusively treated thread embedding acupuncture to the experimental group, 38 out of 61 foreign clinical trials undertook thread embedding acupuncture as the sole treatment. While the 2 domestic RCTs research had no significant evidence that the experimental group was different from the control group, the experimental group demonstrated better responses than the control group in 31 of the 37 foreign RCT studies. Conclusions : Studies on thread embedding acupuncture are more intensively studied in the foreign field in comparison to the domestic field. Referring to the results from the foreign thread embedding acupuncture studies, domestic use of thread embedding acupuncture should be expanded. Also, more refined research needs to be conducted in the domestic field in order for the Koran medicine to lead the thread embedding acupuncture. This study is limited in that the literature search in the foreign journals were restricted.

• Journal of Oriental Neuropsychiatry
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• v.24 no.3
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• pp.201-210
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• 2013

Objectives : To review the recent trend of randomized controlled clinical trials on insomnia and to provide information for future clinical trials. Methods : A total of 667 pieces of literature were searched using the key words 'insomnia' and 'randomized controlled trial' and using the title 'insomnia' with the topic 'trial or trials', published from 2008 to 2012 through Web of Science. Studies including randomized controlled clinical trials were sorted from the search result and finally 104 pieces of the literature were selected and examined. Results : Besides 104 clinical trials, 14 trials related to CAM (Complementary and Alternative Medicine) were also reviewed. On average, 20 trials were annually conducted and they showed a growing trend. Participants were between 31 and 90 (34.6%), and were observed for less than 30 days (28.8%) in most trials. As intervention methods for clinical trials, non-pharmaceutical methods were used in 59 studies (56.7%), pharmaceutical drug in 43 studies (41.3%) and combinations in 2 studies (1.9%). In 60 studies, only insomnia without any underlying diseases was examined and other 44 studies involved other diseases. As diagnosis assessment tools, Sleep diary and Polysomnography were used. Conclusions : Randomized controlled trials relevant to insomnia were on the increase, but only a small number of clinical trials on Oriental Medicine have been performed. Larger scientific and well-founded randomized controlled trials are required for developing Oriental Medicine and establishing high-quality guideline going forward.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.27 no.4
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• pp.45-57
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• 2014

Objective : This study aims to provide fundamental data for new directions(the improvement directions) from searching research papers of randomized controlled trials among thesis of Atopic Dermatitis related to oriental medicine in Korea from 2004 to 2014 and identifying the problem and level of a clinical study through an assessment of the quality, CONSORT statement. Methods : Data was collected through the Koreanstudies Information Service System(KISS). Two experts in Oriental Medicine reviewed the title and abstract in thesis, the results of searching the title, "Atopic dermatitis" and topic, "oriental medicine" at KISS, and then they handsearched Randomized Controlled Trials related to oriental medicine in Korea. According to guidelines defined by CONSORT statement, they assessed whether 37 items were followed by guidelines at yes or no answers in order to evaluate the quality as well. They assessed the definition of each item independently. After comparing, they made a decision on the item of different outcomes through an agreement with a third party. Results : Total number of randomized controlled trials in Atopic Dermatitis related to oriental medicine is eleven. A randomized controlled trial was first published in 2007. One or two papers associated it were released every year except 2013. 9 papers of them were approved by Institutional Review Board and were received written consent. The study included between 20 to 40 subjects for 2-arm parallel study design. The effect of treatment was observed for 4 to 8 weeks. On average, the number followed guidelines was 18.64 among those of 37 CONSORT statement and 50.38% of them was followed overall. Conclusion : As an interest about randomized controlled trials was increased, it was needed to care the standard providing information of CONSORT statement on randomized controlled trials related to oriental medicine in Korea. It is suggested to provide more clear information about it, so that it can be a motive for improving quality of the journal in oriental medicine.

• 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.

• Journal of Acupuncture Research
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• v.24 no.1
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• pp.127-135
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• 2007

Objectives: To evaluate the methodological quality of Korean Acupuncture Clinical trials Methods : Two independent researchers reviewed 12 protocols of Acupuncture clinical trials which were conducted in Korea 2006. Also, Survey Principal Investigator of those was conducted. We compare the results of protocol review with investigator reponses of actual practice. Quality assessment consisted of 5 items including random sequence generation, randomization method, allocation concealment, subject blinding, assessor blinding. Results : Randomization was performed using the proper procedure to insure that treatment assignment is unbiased and concealed from subjects in all clinical trials, According to protocols, 6(50%) of 12 clinical trials used computer-generated random numbers, 6(50%) remaining trials didn't describe the randomization method. Also all trials used appropriate randomization methods on the basis of the survey results: 8 trials used computer-generated random number, 2 used random table. Of 7 protocols in which allocation concealment was stated, 5(71%) reported appropriate method (Calling a central office or statisticians, Sealed opaque envelopes). However according to survey, 5(42%) of 12 trials used inappropriate allocation concealment (Keeping a master randomization list and referring to when subject entered the trial). In addition, the result of protocol review and survey response was not coincident in 5(42%) trials. Subject blinding was conducted in all except 1 clinical trials. Although 11(92%) of 12 trials were conducted using assessor blinding in actual practice, only 7(58%) reported that in protocol. Conclusion : Although randomization and blinding were conducted adequately, allocation concealment was used inadequately, Not only appropriate allocation concealment, but also every quality assessment item including randomization, blinding should be stated in more detail in protocol.