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

• Korean Journal of Biological Psychiatry
• /
• v.19 no.4
• /
• pp.153-158
• /
• 2012

Understanding of a clinical trial is essential in developing clinical guideline and adopting evidence based practice. In designing and executing clinical trials, following ethical requirements should be considered : social value, scientific validity, fair subject selection, informed consent, favorable risk-benefit ratio, institutional review board, and respect for human subjects. According to the stage of drug development, purpose of trials, accumulated scientific data, clinical trials for drug development are classified as phase 1, 2, 3, and 4. Phases of clinical trials can be overlapped and the judgment of entering into the next phase should be considered highly strategically. In reading, evaluating and interpreting clinical trial reports, various skills and challenges exist. Patient sample composition, trial duration, selection of endpoints, responders and non-responders, placebo effect, patient recruitment, and extrapolation to the real world are the examples of those challenges. Treatment success will come from the well balanced approach of evidence based decision making and consideration of specific single case.

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

• 대한예방의학회:학술대회논문집
• /
• 1994.02b
• /
• pp.336-341
• /
• 1994

Multicenter controlled clinical trials require It synthesis of the scientific method and the precepts of modern management. The management tasks associated with these studies are akin to those found in other kinds of complex corporate endeavors. It is recommended that clinical investigators become more knowledgeable about management concepts and methods and management specialists be given a major role in the planning and conduct of large-scale clinical trials.

• The Journal of the Convergence on Culture Technology
• /
• v.4 no.4
• /
• pp.387-392
• /
• 2018

Clinical trials are an important part of developing new medical devices or developing new drugs. However, it takes many time and expense to conduct clinical trials. In order to solve this problem, it define the standard format of the data collected in clinical trials in major countries and in Korea. Clinical trials are also underway in korean medicine to develop new medical devices. If it define the standards for the data we collect in clinical trials, there are likely to be a variety of ways to use them. If it collect and manage various clinical trial data as one standardized data, you will be able to draw various results. Based on these findings, we established a system for collecting and managing integrated data on clinical trials. And let's look at how to use it.

• Journal of Korean Biological Nursing Science
• /
• v.16 no.3
• /
• pp.192-200
• /
• 2014

Purpose: The aim of this study was to develop a new course entitled 'Clinical Research Management' to enhance nursing students' clinical competency in handling clinical trials. Methods: The goals and content of the existing current education program for clinical research professionals such as clinical research coordinators and clinical research associates provided by the Korea National Enterprise for Clinical Trials were analyzed to identify the core educational concepts. A focus group interview was performed to investigate essential competency levels for the professionals who were to begin their career in the area of clinical trials after graduating from the college of nursing. Through these initial processes, we identified the core competency required for clinical research professionals and the related course content. Goals and objectives based on the specified four competencies were set and confirmed by expertise review. Results: We developed a new course entitled Clinical Research Management, a 16-week elective subject consisting of various teaching and learning strategies based on four core competencies: basic knowledge on clinical trials, communication, risk management, and ethics. Conclusion: The results of this study will contribute to enhancing nursing students' clinical competency, including knowledge, skills, and attitudes relevant to clinical trials.

• The Journal of Korean Medicine
• /
• v.32 no.4
• /
• pp.128-138
• /
• 2011

Objective: This study aimed at providing preliminary data useful in reducing participant dropout and improving the quality of clinical trials, by analyzing the factors related to dropout. Methods: The data came from 15 acupuncture and/or moxibustion clinical trials (n=638; August 2005 to December 2009). Logistic regression analysis was used to reveal factors influencing participant dropout. Results: Gender, age, treatment method (intervention), treatment frequency, availability of follow-up, and presence of compensation treatment for the control group were factors influencing participant dropout. Conclusion: Subsequent studies of large-scale acupuncture and moxibustion clinical trials should address dropout factors that consider the character of each clinical trial, or general characters like participants' gender, age, occupation, and diverse diseases.

• Journal of Society of Preventive Korean Medicine
• /
• v.20 no.3
• /
• pp.93-113
• /
• 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 Society of Preventive Korean Medicine
• /
• v.19 no.1
• /
• pp.47-59
• /
• 2015

Objective : The purpose of this study was to analyze the trend of clinical research on 'mild and sub-clinical depressions' in China. Method : The journal search was performed using China National Knowledge Infrastructure(CNKI). Our inclusion criteria were as follows: TCM clinical trials for mild, sub-clinical, early stage of depression. Exclusion criteria were the following: non-TCM clinical trials, disease-associated depression related clinical trials. Results : We included 16 papers in this study. 1. In this study, we realized there have been several mild and sub-clinical depressions related clinical trials conducted in the field of TCM. 2. The result of 10 Journals used the Hamilton Depression Rating Scale for diagnosis and assessment criteria of mild and sub-clinical depressions. 3. The selected journals categorized by various interventions, such as, herbal medicine(7), acupuncture(4), miscellaneous(5). 4. Also, 7 Journals showed the significant improvements in patients with mild and sub-clinical depressions by TCM interventions, and 5 studies of TCM patent prescription reported that herbal medicine therapy has less side effect than the western medicine. Conclusion : Through this study, we found out that several researchers in China performed clinical trials on mild and sub-clinical depressions constantly. From the result of this study, we need to concern about the necessity of research on the mild and sub-clinical depression in Korea. Therefore, this result could be used as a meaningful reference for the design of future clinical trials.

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