• Proceedings of the Korean Society of Applied Pharmacology
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• 1997.11a
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• pp.57-74
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• 1997

To make a proposal for the revision of KGCP, ICH Harmonized Tripartite Guideline for Good Clinical Practice, which is on the stage of worldwide implementation, was compared with current GCPs of tripartite countries of ICH, namely USA, Europe and Japan as well as Korea. On the basis of the classification in ICH GCP, comprehensive comparisons among the corresponding articles of 4 regions or countries were made in the order of IRB / IEC, Investigator, Sponsor and Clinical Trial Protocol. Based on the comparisons of the contents in ICH-GCP with those in current GCPs, major suggestions for the revision of current KGCP can be made as follows. Firstly, the function of IRB / IEC needs to be strengthened for the initiation and continuation of clinical trial. Current 2-step approval system of IRB / IEC and Health Authorities requires to be converted into the system similar to that of developed countries. Secondly, sponsor's obligation needs to be tightened to control and assure the quality of clinical trial. Inspection of regulatory authorities should be made to perform during and / or after clinical trial, when it is necessary. In other words, sponsor should be made to establish written Standard Operating Procedures (SOPs) for all aspects of clinical trial including monitoring to ensure that trials are conducted and data are generated, documented, and reported in compliance with the protocol, GCP, and the applicable regulatory requirement (s). Besides, the provision of ‘Quality Control and Quality Assurance’ should be added to the protocol to establish the credibility of the result of the clinical trial.

• 대한임상약리학회:학술대회논문집
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• 1996.05a
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• pp.93-98
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• 1996

• The Journal of KAIRB
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• v.2 no.1
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• pp.23-31
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• 2020

Purpose: To obtain opinions from Korean Institutional Review Board (IRB) members' self-evaluation on ability to conduct fairness review of clinical trial protocol with presence of conflict of interest and from investigators and IRB members on financial conflict of interest through surveying. Methods: IRB members and researchers in 9 different hospitals were asked to answer survey questions via email. Results: Responders were 115 personnel (IRB Chair/vice 18, medical member 30, non-medical member 28, and researcher 39) from 9 centers. Compared to IRB medical members, IRB chair/vice respondents scored higher with statistically significance on 10 point scale (8.44±1.381 vs. 7.30±1.685, p=0.005) when asked to self-evaluate fairness reviewing a protocol proposed by an investigator from the same department and a protocol from the company that supports the scientific committee of responders. When reviewing a protocol proposed by a hospital director, non-medical members scored statistically significantly higher than medical-members (7.47±1.76 vs. 8.07±2.70, p=0.034). When asked about the limitation of labor fee for principal investigator on phase 3 Human clinical trials of the Investigational new drug, while the responses range was wide, 60% answered that labor cost of principal investigator should be less than 30% of total budget for clinical trials with a budget of 100 million won. 51.3% answered that there is no need to disclose the labor cost of the principal investigator in the consent form. Since every investigator can be influenced unconsciously by conflict of interest, the answer that 'responder agrees that there is need for management' was the most chosen answer (IRB member 61.8%, investigator 64.1%, multiple answers allowed). Conclusion: Considering scores on questions of fairness by IRB members were between 7.23-8.56 on scale of 0 to 10 point when IRB members were asked about reviewing a clinical trial protocol, it cannot be said with absolute certainty that there is no issue regarding fairness in the review process. Therefore, there should be more ways to safeguard fairness for these issues. There is a need that the disclosure amount of honorarium from sponsor should be lower than 100 million Korean won. Considering the results of the survey in which respondents expressed their thoughts, it is likely that more education on the concept of conflict of interest is needed.

• Korean Journal of Clinical Laboratory Science
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• v.45 no.4
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• pp.154-158
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• 2013

The unnatural dead body refers to a corpse which is suspicious of unusual death and the dead case has been occurred more than 20 thousands times every year during the recent five years and most of them are found decayed. Police Scientific Investigators investigate unnatural dead bodies and its surroundings in all-around way and determine whether the death is involved with a crime, and most of the Scientific Investigators are exposed to a danger to get infected with pathogenic bacteria which are generated during the decaying process of dead body and are mostly to cause serious injuries on human beings. In line with the fact, the present study conducted a bacterial analysis by collecting excretions from 60 dead bodies and culturing the bacteria to evaluate infection risk of the police agents. The study cultured bacteria from 60 bodies and classified pathogenic bacteria of 108 strains, and its main bacteria are found to be them (; Acinetobacter baumannii 20 strains (19%), Pseudomonas aeruginosa 19 strains (18%), E. coli 18 strains (17%), Klebsiella pneumoniae 11 strains (10%), Proteus mirabillis 10 strains (9%), Enterococcus faecium 10 strains (9%), Staphylococcus aureus 9 strains (8%), Bacillus spp. 5 strains (5%), Streptococcus pneumoniae 3 strains (3%), Candida albicans 2 strains (2%), Mycobacterium tuberculosis 1 strains (1%)). The study results are expected to be used as educational data for preventing the Police Scientific Investigator from infections with bacteria or as a minimum data for improving work environment of the agents.

• 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.

• Korean Journal of Veterinary Research
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• v.45 no.3
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• pp.439-444
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• 2005

A 7.1 kg, seven-year old, castrated male, Shih-Tzu with severe pruritus, chronic otitis externa and Malassezia infection was referred to Veterinary Medical Teaching Hospital of Chungnam National University. In local animal hospital, steroid therapy was used to treat uncontrollable pruritus, but the clinical signs were recurrent when steroid therapy was discontinued. On physical examination, generalized alopecia, erythema, papules, severe crust and diffuse lichenification were presented. Tape strip test of skin lesions revealed cocci and Malassezia infections. Based on the result of history, clinical signs and examination described above, canine atopic dermatitis with secondary superficial pyoderma and Malassezia dermatitis was diagnosed. Oral challenge with cyclosporine and antibiotics had good results in clinical signs. Clinical sign scores were evaluated by investigator with CADESI at 2weeks, 4weeks, 6weeks, 8weeks and 10weeks after cyclosporine administration. And in the result of comparing of allergen-specific IgE value, the level of allergen-specific IgE to general causative allergen after 10 weeks of cyclosporine therapy was higher than that before cyclosporine therapy.

• Journal of Sasang Constitutional Medicine
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• v.20 no.3
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• pp.118-132
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• 2008

1. Introduction This study aims to survey knowledge and attitude of Sasang constitution investigators on the Sasang constitution clinical study. 2. Methods We have made up list of 24 Sasang constitution investigators who have conducted Sasang constitution clinical study before. The study has been surveyed for 20 investigators who has been experiencing clinical study bye-mail or interview. 3. Results 1) The recognition degree on clinical study for sasang constitutional investigators was relatively lower than that for non-oriental investigators. 2) Most investigators have difficulty in designing a Protocol and they thought Protocol is most important in clinical study. 3) The investigators has stressed the need of diagnosis guideline on Sasang Constitution in performing clinical study. 4. Conclusions Special course of clinical study for sasang constitutional investigators should be prepared to activate Sasang constitution clinical study. This course may set up the guideline of sasang constitution clinical study and designing protocol. Also it is urgent to develop constitution diagnosis guideline for clinical study.

• Journal of Korean Medical classics
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• v.23 no.4
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• pp.63-102
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• 2010

Purpose : To propose various types of clinical research which is feasible for botanical new drug (IND) development processes, and suggest essential steps to development of study protocol for IND. Methods : Literature-based discussions and one research group's experience is given regarding domestic act, regulation, and system. Results : In order to get an approval of IND for botanical drug in Korea there are several types of clinical research to conduct. In quality control steps for standardized medicinal herbs, case reports or case series can be conducted, and for good manufacturing practice(GMP) steps, we can conduct case reports, case series, and retrospective cohort studies. In addition, as long as we gathered good laboratory practice(GLP) data we can conduct up to quasi-experimental studies and clinical trials including investigator initiated trials. In order to conduct these studies development of study protocol is essential. First, we obtain historical evidence including target disease and indication, efficacy, safety, and endpoints by reviewing medical classics. Second, we obtain clinically and statistically important data by conducting non-clinical studies, observation studies, and quasi-experimental studies. Third, we generate research hypotheses and purposes and explore methodologies, endpoints, clinical practice guidelines, cost-effectiveness, and commercial potential. Finally, we develop study protocol with aid of biostatistician or expert in contract research organization. Discussions and conclusions : This study have obvious limitations in that most thoughts, suggestions, and proposes are from one research group's experience. Therefore, we hope to see various types of research in this topic and process from other research group as well.

• Quality Improvement in Health Care
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• v.27 no.1
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• pp.20-25
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• 2021

Purpose: The ability to access clinical trials for cancer treatment is important. This study investigated whether regional differences exist in oncologic clinical trial protocols conducted in South Korea. Methods: Records of all approved oncologic clinical trials conducted in 2019 were downloaded from the Republic of Korea Ministry of Food and Drug Safety. The study covered Seoul, the capital area, other metropolitan cities, and provincial areas. Descriptive statistics summarized the distribution patterns of clinical trials by region. Results: A total of 202 oncologic clinical trials were conducted in 63 institutions in 2019. Of these protocols, 186 (92%) were available in Seoul, 120 (59%) in the capital area, 64 (32%) in metropolitan cities, and 66 (33%) in provincial areas. More regional differences in protocol availability were observed in domestic trials, investigator-initiated trials, phase 1 and 2 trials, and smaller-scale trials. Conclusion: Most oncologic clinical trials were conducted in medical institutions located in Seoul, with the rest conducted in the capital area, metropolitan cities, and provincial areas. The findings reveal clear differences in protocol availability between Seoul and the other regions. Measures designed to improve geographical access to oncologic clinical trials may be needed given their growing importance in cancer treatment.

• Medical Lasers
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• v.9 no.2
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• pp.187-189
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• 2020

Cold atmospheric plasma (CAP) is a material that generates free radicals through the ionization of air. Despite the application in various medical fields, the efficacy and safety of CAP on post-inflammatory hyperpigmentation due to atopic dermatitis have not been reported. Herein, we report the improvement in post-inflammatory hyperpigmentation of atopic dermatitis, after CAP treatment of three sessions weekly, 10 minutes per session. We examined the clinical severity indexes before and after treatment, including the Investigator's Global Assessment, modified Atopic Dermatitis Antecubital Severity, Eczema Area and Severity Index, and pruritus visual analogue scores. Our results indicate that CAP alleviates the post-inflammatory hyperpigmentation and clinical severity of atopic dermatitis, and effectively improves the atopic skin lesion without severe safety issues. We believe that the previously reported anti-bacterial effects and production of interleukin-6 after CAP treatment are probably responsible for the underlying mechanisms leading to clinical improvement.