• 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.

• Restorative Dentistry and Endodontics
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• v.49 no.1
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• pp.5.1-5.11
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• 2024

Objectives: This study aimed to present the results and analyses of clinical trials, including updates on the different functions of root canal sealers. Materials and Methods: In June 2023, we performed a comprehensive search of ClinicalTrials.gov to identify interventional clinical trials pertaining to root canal sealers. In total, 23 clinical trials conducted up to June 2023 were included in this study. Results: Approximately half of the trials (11 out of 23) were completed, while none were terminated or withdrawn. Each included trial had a minimum of 10 participants, with 11 trials having more than 100 participants. None of the assessed trials provided outcomes, and the majority (17 out of 23) lacked associated publications. In terms of geographic distribution, the USA and Canada did not contribute to any root canal sealer trials. Conclusions: This study highlights the lack of diversity in trial locations, the absence of reported results, and a scarcity of clinical trials examining the physicochemical properties of different sealers. Most published trials primarily focused on assessing the post-operative pain effect of these sealers, but no significant difference was found regarding post-operative pain control.

• The Journal of the Korea Contents Association
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• v.12 no.12
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• pp.714-720
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• 2012

With the help of information technology, it is the most important to collect clinical data correctly in clinical trials. For this, recently, in many pharmaceutical companies and Clinical Research Organizations (CRO) have tried to adopt an Electronic Case Report Form (eCRF) system. The eCRF system is a computerized system designed for collecting and managing clinical data in clinical trials. Although the eCRF is recognized as a significant system for clinical trials, until now there are no widely useable, due to the huge effort and expense at the initiatory stage of adopting eCRF system. In this study, we inquired the use of eCRF system developed for clinical trial at Korea Institute of Oriental Medicine. Especially, we focused on the time required for entering clinical data into the eCRF, hours of use, and the number of queries according to the time flow.

• The Journal of Internal Korean Medicine
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• v.40 no.1
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• pp.89-116
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• 2019

Objective: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer," by analyzing existing guidelines and clinical trials. Methods: Committee for the development of a guideline, consisting of 6 Korean medicine doctors, reviewed guidelines and clinical trials on using herbal medicine for treating liver cancer. The trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparators, outcomes, and trial design. We then compared the results of our analysis with the guidelines to identify issues we must to consider when following the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer." Several guidelines for antitumor agents and clinical trials on herbal medicine were obtained from the Ministry of Food and Drug Safety homepage, etc. The search terms were as follows: "liver neoplasms"; "herbal medicine"; "medicine, Korean traditional"; and "medicine, Chinese Traditional.". Results: Ten articles were obtained from pubmed and Embase. There was no guideline for clinical trials on using herbal medicine for treating liver cancer. All the participants in the reviewed articles had primary liver cancer, and the type of intervention varied (e.g., decoction, patches, and capsules. The comparators included placebos and conventional treatments such as chemotherapy. The outcome assessment methods were tumor response, quality of life, survival, and liver function tests. Adverse events occuring during the trial were also evaluated. Conclusion: Findings were derived by reviewing existing guidelines and comparing them with clinical trials on liver cancer and herbal medicinal products. These results will be utilized in the development of the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer."

• 대한예방의학회:학술대회논문집
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• 1994.02b
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• pp.206-233
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• 1994

The Medical Research Council has for some years encouraged collaborative clinical trials in leukaemia and other cancers, reporting the results in the medical literature. One unreported result which deserves such publication is the development of the expertise to design and analyse such trials. This report was prepared by a group of British and American statisticians, but it is intended for people without any statistical expertise. Part!, which appears in this issue, discusses the design of such trials; Part II, which will appear separately in the January 1977 issue of the Journal, gives full instructions for the statistical analysis of such trials by means of life tables and the logrank test, including a worked example, and discusses the interpretation of trial results, including brief reports of particular trials. Both parts of this report are relevant to all clinical trials which study time to death, and would be equally relevant to clinical trials which study time to other particular classes of untoward event: first stroke, perhaps, or first relapse, metastasis, disease recurrence, thrombosis, transplant rejection, or death from a particular cause. Part I, in this issue, collects together ideas that have mostly already appeared in the medical literature, but Part II, next month, is the first simple account yet published for non-statistical physicians of how to analyse efficiently data from clinical trials of survival duration. Such trials include the majority of all clinical trials of cancer therapy; in cancer trials, however, it may be preferable to use these statistical methods to study time to local recurrence of tumour, or to study time to detectable metastatic spread, in addition to studying total survival. Solid tumours can be staged at diagnosis; if this, or any other available information in some other disease is an important determinant of outcome, it can be used to make the overall logrank test for the whole heterogeneous trial population more sensitive, and more intuitively satisfactory, for it will then only be necessary to compare like with like, and not, by chance, Stage I with Stage III.

• Korean Journal of Acupuncture
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• v.25 no.2
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• pp.71-85
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• 2008

Objective : Acupuncture, one of the Oriental medical treatment techniques in East Asia, is growing in popularity all over the world. Based on bibliographical and clinical data, the depth of needling, i.e. superficial or deep needling, has been considered to be a variable as potential modifiers of needling effects, such as localization, manipulation of the needle, or elicitation of DeQi. The purpose of this review is to summarize clinical trials using minimal acupuncture and to evaluate its appropriateness as a control. Methods : A survey of computerized literature searches for randomized controlled trials using minimal acupuncture revealed that a total of 10 studies were published until April 2008. Results : Results obtained from clinical trials showed that acupuncture were more effective than minimal acupuncture in 3 out of 10 trials, while others were no more effective than control. However, minimal acupuncture might neither be a inert placebo nor be indiscriminable. Conclusion : Minimal acupuncture as 'placebo' controls seems misleading and scientifically unacceptable.

• The Journal of Korean Medicine
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• v.26 no.2 s.62
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• pp.85-94
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• 2005

Objectives: This study was carried out to estimate the demand for clinical trials and contribute to the consolidation of function and role in the clinical trial centers of oriental medicine. Methods: A survey of the demand was made of 379 faculties of oriental medicine in 11 oriental medical colleges throughout the country using two?part investigations by e-mail questionnaire over 1 month. The final data from 56 faculties were analyzed. Results: Clinical trials of oriental medicine have been continuously increasing. Furthermore, the demand and necessity for clinical trials of oriental medicine have also been continuously enhanced. Although there were arguments for and against the establishment of a clinical trial center for oriental medicine, the demand and necessity for the establishment was the overall consensus. Concerning objections, a high intention of use was observed. Conclusions: These results imply that the demand for clinical trials will increase remarkably through the establishment of a clinical trial center for oriental medicine. Further study is needed about the demand for such a center.

• The Journal of Korean Medicine
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• v.36 no.3
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• pp.84-97
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• 2015

Objectives: The purpose of this study was to investigate and analyze the demands for educational programs on clinical trials of Korean medicine devices, and develop training programs based on the needs of Korean medicine. Methods: This research was conducted targeting 26 volunteer applicants who had participated in clinical trials of Korean medicine devices within the last five years (2010-2015). The survey was carried out between May 1, 2015 and May 26, 2015 via e-mail. After receiving questionnaire replies, the material was established. Using obtained data, frequency analyses were performed using SPSS 20.0 version. Results: 92% of the researchers who participated in the survey expected introduction of educational programs on clinical trials and anticipated that programs contain information that can meet the needs of each researcher. In addition, according to the analysis, introducing expert certification for clinical trials of Korean medicine devices is necessary, and offering related graduate courses are also needed. Conclusions: As a result of this study, researchers had difficulties during clinical trials of Korean medicine devices. If the educational programs were to be developed and institutional frameworks support them effectively, it would prove to be helpful to researchers in clinical trials.

• Korean Journal of Clinical Pharmacy
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• v.28 no.2
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• pp.146-153
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• 2018

Objective: Multi-regional clinical trials have been widely used for accelerating global drug development by multinational pharmaceutical companies. In this study, we aimed to review and analyze the international trends in regulations and guidelines on multi-regional clinical trials by regulatory authorities and international organizations, such as International Conference on Harmonisation, for referring to policies, including development of domestic guidelines for multi-regional clinical trials. Methods: The policies, regulations, and guidelines published by the US Food and Drug Administration, European Medicines Agency, Pharmaceuticals and Medical Devices Agency (Japan), and China Food and Drug Administration were searched, and the International Conference on Harmonisation E17 draft guideline was reviewed. Results: The regulatory authorities in developed countries have developed and implemented regulations and guidelines on multi-regional clinical trials to promote simultaneous global drug development and evaluate the regional differences in drug safety and efficacy. International Conference on Harmonisation developed the draft guideline for planning/designing of multi-regional clinical trials in 2016, which recommends the general principles for strategy-related issues and design of multi-regional clinical trials, and for protocol-related issues, such as consideration of regional variability, subject selection, dose selection, endpoints, comparators, overall sample size, allocation to regions, collecting information on efficacy and safety, and statistical analysis. Conclusion: It is important to understand the international regulatory requirements for designing and planning of multi-regional clinical trials for global drug development. Moreover, it is necessary to prepare multi-regional clinical trial guidelines in accordance with the Korean regulation for clinical trials and drug administration.

• Asian Pacific Journal of Cancer Prevention
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• v.14 no.4
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• pp.2181-2184
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• 2013

Prostate cancer is the most common malignancy in men in the United States. Surgery or radiation are sometimes unsatisfactory treatments because of the complications such as incontinence or erectile dysfunction. Selenium was found to be effective to preven prostate cancer in the Nutritional Prevention of Cancer Trial (NPC), which motivated two other clinical trials: the Selenium and Vitamin E Cancer Prevention Trial (SELECT) and a Phase III trial of selenium to prevent prostate cancer in men with high-grade prostatic intraepithelial neoplasia. However, these two trials failed to confirm the results of the NPC trial and indicated that the selenium may not be preventive of prostate cancer. In this article we review the three clinical trials and discuss some different points which might be potential factors underlying variation in results obtained.