• Korean Journal of Acupuncture
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• v.24 no.3
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• pp.33-45
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• 2007

Background : Hot flushes are general postmenopausal symptoms which about 75% of climacteric women undergo. They affect hotness, perspirations, systemic weakness, panic disorders, insomnia. Acupuncture is effective in alleviating hot flushes in practice. Assessment effectiveness and safety of acupuncture in hot flushes would be needed through multi-center trial. Objectives : Purpose of this study is to develope the protocol of effects of acupuncture on hot flushes, a postmenopausal symptom in climacteric women. Methods & Results : It will be a multi-centered, randomized, sham controlled, comparative trial. It will be performed by Good Clinical Practice after approval of Institutional Review Board. Selection criteria will be set according those of FDA above moderate degree. There will be a notice on concomitant medication, other herbs, dietary supplements. Superficial needling on sham points will be used for control group. Treatment period will be 8 weeks with 12 weeks' follow up. Some questionnaire scale will be used as the primary and secondary outcome. Conclusions : The clinical trials based on this protocol will be performed.

• Korean Journal of Acupuncture
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• v.29 no.4
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• pp.581-597
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• 2012

Objectives : To explore the experiences of patients with chronic low back pain(CLBP) in a randomized controlled trial(RCT) of acupuncture. Methods : Five qualitative focus group interviews were conducted at three Korean Medicine Hospitals. Two to 4 participants from the same group(real or sham acupuncture) in the RCT of acupuncture for CLBP discussed their experiences and perceptions of the clinical trial and the acupuncture treatment. Transcribed data were read independently by researchers and analyzed to categorize information and identify themes. Results : A total of 14 participants were included. Most of them discovered positive aspects of being a study subject and a patient. They recognized the differences between experimental and real-world clinical settings such as formal procedures of treatment, and different acupuncture device. Participants also expressed the weaker sensation of acupuncture compared to the previous experience. Especially, they were well aware of the 'subjects' role themselves, thus they observed their changes of symptom closely. As subjects were generally satisfied with their treatment and they had a good feeling to acupuncture after the trial, they expressed their willingness to participate in the future clinical trial of acupuncture. Conclusions : Our finding suggests that the Korean patients' experience of participating in an RCT was generally positive. Their tendency to perform the 'subject' role might affect the trial's process or overall results.

• 대한임상약리학회:학술대회논문집
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• 2002.12a
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• pp.30-30
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• 2002

• 한국데이터정보과학회:학술대회논문집
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• 2005.04a
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• pp.200-201
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• 2005

• Proceedings of the PSK Conference
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• 2001.10a
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• pp.317.2-318
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• 2001

• Proceedings of the PSK Conference
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• 2001.10a
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• pp.317.1-317.1
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• 2001

• The Journal of KAIRB
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• v.3 no.2
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• pp.19-27
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• 2021

Purpose: This study aimed to analyze the knowledge levels, attitudes, and factors affecting the choices on the education of the participants who completed their education of persons conducting clinical trial workers, and to assess the problems of the current education system for clinical trial workers, leading to improvements. Methods: Clinical trial workers (including principal investigators/subinvestigators, members of the Institutional Review Board [IRB], clinical research coordinators) who were affiliated to one of the 4 university hospitals running their own clinical trial center and IRB in Daegu and completed their education of persons conducting clinical trial workers were the subjects of this study. One hundred seven online questionnaires were answered from 2021-04-02 to 2021-04-17. Descriptive statistics and Pearson correlation analysis were used to analyze the acquired data. Independent t-test and 1-way analysis of variance were used to analyze the differences in the knowledge levels and attitudes following the characteristics of the education participants. Results: The baseline characteristics of the 107 participants were as follows: the majority of the participants were female (72.0%), were in their 30s (36.4%), had a nursing major (29.0%), were clinical research coordinators (63.6%), had never experienced a principal investigator (79.4%), had participated 3 or more educations (58.9%), had completed their maintenance course (55.1%), had 5 or more years of clinical trial experiences (34.6%). The fields on which participants had low levels of objective knowledge were "types and preparations on audits of clinical trials," "regulations on clinical trials (Pharmaceutical Affairs Act, Korea Good Clinical Practice)." The difficulties that the participants faced were on "annual educations" and "lack of information regarding the educations." Factors that showed significant differences in objective knowledge were sex (p=0.02), number of educations (p=0.004), the curriculum of 2020 (p=0.001). Age (p=0.004), having experienced a principal investigator (p=0.006), number of educations (p<0.001), the curriculum of 2020 (p<0.001), clinical trial career (p=0.001) were factors that significantly affected subjective knowledge. Attitudes toward the education were positively correlated with objective knowledge (r=0.20, p=0.04) and subjective knowledge (r=0.32, p=0.001). Major sources through which information on educations was acquired were "institutional notices," and major factors affecting the choices on the education were "when the education took place" and "where the education took place." "Within the affiliated institution," "Online classes (recorded)" and "IRB and review processes" were each the most preferred place, mode, and content of the education. Conclusion: Knowledge levels varied largely among participants who completed their education of persons conducting clinical trial workers, depending on their characteristics such as the number of educations. Participants also complained about their lack of information on educations. The quality of education may be improved if clinical trial organizations are designated as education facilities. Education programs must be developed considering the knowledge level and demand of the participants. Furthermore, as offline classes may be impossible due to pandemics such as the coronavirus disease 2019, the development of diverse and sophisticated online classes is looked forward to.

• Korean Journal of Clinical Pharmacy
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• v.32 no.3
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• pp.166-177
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• 2022

Background: Recently clinical trials have expanded extensively in Korea; thus, ensuring the rights of subjects participating in clinical trials is imperative. Accordingly, national regulations on subject recruitment advertisement were enforced from October 25, 2018. In this study, the effect of this regulation was evaluated by analyzing the difference in the provision of information before and after enforcement of the regulation. Methods: Recruitment advertisements for clinical trial subjects 3 years before and after enforcement of the regulation were collated by the significance sampling approach. Print-based (newspapers, buses, and subways) and web-based (clinical trial center websites and online platforms) materials for recruitment in clinical trials of phase 1 to 4 for investigational drugs, medical devices, and oriental medicine were considered. Chi-square tests were conducted for inter-group comparisons. SPSS version 26 was employed for statistical analyses. Results: A total of 137 advertisements were collected comprising 60 pre- and 77 post-regulation enforcement. The overall rate of delivery of critical information in advertisements increased significantly from 47.5% before regulation to 93.2% after regulation enforcement. Particularly, details on expected adverse events augmented significantly (p<0.001). Benefits from participation in clinical trial reduced significantly from 88.3% to 70.1% (p<0.05). As the information provision amplified, the inclusion of professional terms increased. Conclusions: Enforcement of regulations has led to a surge in the amount of information and challenging terms contained in advertisements for recruiting subjects. Therefore, additional efforts are required by subjects to completely understand the information provided in the advertisements.

• 대한예방의학회:학술대회논문집
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• 2001.10a
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• pp.302-304
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• 2001

• 대한임상약리학회:학술대회논문집
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• 2006.11a
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• pp.147-149
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• 2006