• The Journal of the Korea Contents Association
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• v.13 no.4
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• pp.281-289
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• 2013

As the number of clinical trials conducted in Korea increases, the need of the Electronic Data Capture (EDC) system for effective clinical data management is also increased. Recently, the Korea Food and Drug Association published 'Guideline for the Electronic Clinical Trial Data Management and Processing' and it would be the foundation for establishing regulation of electronic clinical data management. In this research, we conducted the survey regarding adoption rate of EDC system in clinical trials in hospitals, Contract Research Organizations (CRO), and pharmaceutical companies. And the perceived importance and the ease of application for the Guideline were investigated. The adoption rates of EDC system was 77.6% but it mostly applied to less than five trials. Also EDC system was mostly used in phase I and phase II trials and the utilization rate of CRO was the highest. The perceived importance for the Guideline was high among all three organizations but, in case of the perceived ease of its application, CRO was the highest. Also, the perceived importance of the clinical data standard was high and the standard for data collection was mostly required. However, the comprehension for the global standard of the electronic data was relatively low, so that education is required. This result would be the foundation to increase the electronic clinical trials and develop proper regulation and principles for clinical data standards in Korea.

• Journal of Oriental Neuropsychiatry
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• v.20 no.2
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• pp.163-176
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• 2009

Objectives : To address most probable and suitable method for designing clinical trial intervening Traditional Korean Herbal Medicine on hwa-byung. Study Design : A systematic review of research studies of complementary and/or alternative medical(CAM) treatment of depression, and of domestic clinical trials of Traditional Korean Medicine, and of Chinese clinical trials of Traditional Chinese Medicine. Methods : Randomized, controlled trials(RCTs) of treatment of depression intervening herbal medicine were searched through MEDLINE, Cochrane Library, and CNKI databases. Also, domestic RCTs intervening Traditional Korean Herbal Medicine were searched through Korean Traditional Knowledge Portal and Korean studies Information Service System(KISS). Studies were evaluated using Iadad scale and self-designed tool for this study. Results : Thirty four RCT studies( 10 from MEDLINE, 16 from CNKI, 8 domestic studies) of herbal medicine met inclusion criteria. Mean Jadad score of studies published in English was 2.8${\pm}$0.79, in Chinese 1.94${\pm}$0.77, and in Korean 2.75${\pm}$0.71. Twenty one percent of studies included pattern differentiation in their inclusion criteria. Twenty nine percent of studies used combined treatment of herbal and conventional medicine. Among studies on depression, 9% included Complementary Medical assessing tools. Conclusions : There is shortage of domestic clinical trial involving herbal medicine. In China, studies tend to focus on investigating effect of Combined treatment of herbal and conventional medicine on depression. Clinical trial(s) of hwa-byung should provide good internal validity by describing methodology for randomization, double-blinding, and attrition. Also, specific guideline for clinical trial, including Traditional Korean Medical aspects across inclusion criteria, and assessing tools is needed.

• Journal of Physiology & Pathology in Korean Medicine
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• v.20 no.6
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• pp.1678-1727
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• 2006

This study was perfromed to develop the assessment guideline and endpoints for clinical trial with anticancer herbal medicine. The botanical products used to humans for long time may be applied to phase 3 clinical trial after submitting the evidences for safety and efficacy of them or completion of basic requirement of phase 1 and phase 2 for safety confirmation and dose determination. Syndrome improvement was chiefly evaluated by Zubrod and karnofsky(%) methods. We suggest the general clinical trial assessment with botanical products, by following assessment points, that is, tumor size for 50 points, survival fate for 10 points, major syndromes for 40 points. It is recommendable that the each symptom of Qi deficiency syndrome, blood deficiency syndrome and Qi stagnation syndrome was allocated by assessment points, Similarly, the each symptom was given the assessment points according to the severity of symptom, for example, slight for 3 points, moderate for 2 points and severe for 1 point in hepatocelluar carcinoma and lung cancer. Then, the efficacy of botanical products was evaluated by the difference between pre-treatment and post-treatment. Asking the neoplastic patients of questionnaire on physical, emotional, cognitive, social and role subjects availability, three more syndromes (Fatigue, Pain and Nausea/Vomit), quality of life(QOL) will be evaluated by GLM statistics. In addition, in case of lung cancer, 13 questions will be asked by the EORTC QLQ-C13 forms. As the assessment of endpoints for efficacy to reduce side effects induced by chemotherapy and radiotherapy, the data of image scanning and hemato-urinalysis can be usefully applied on immune response, weight loss, indigestion, hemopoietic damage and injury of liver and kidney, while the changes of syndromes of side effect can be evaluated by differentiation methods of Qi and blood and five viscera. However, it is still necessary to determine the ratio between scientific analytical method and Oriental differentiation method as well as confirm the Oriental assessment endpoints by clinical trial. In addition, we suggest the continuous development of assessment endpoints on other carcinomas except of hepatocelluar carcinoma and lung cancer in future.

• The Journal of KAIRB
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• v.5 no.1
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• pp.14-20
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• 2023

Purpose: To obtain fundamental data on selection tools for an internal audit and develop a new guideline. We scored the indicated points from the internal audit, identified the research progress and problems that occurred, and confirmed the validity of the risk factors involved. Methods: Of the 63 internal audits conducted by Keimyung University Dongsan Hospital from 2014 to 2021, we analyzed 55 clinical trials with an inspection checklist. We excluded 8 that failed to transfer data and refused to comply with the internal audit. The statistical summary of the collected data was verified and interpreted by using frequency analysis and a chi-square test. Result: Of total 55 cases included in the internal audit, sponsor-initiated trial (SIT) was 63.6% (vs. investigator-initiated trial [IIT]), clinical trial for investigational drug was 71.0% (vs. nonclinical or clinical trial for investigational device), domestic multicenter trial was 60.0% (vs. single center or multinational multicenter trial), and trial requisition for MFDS approval was 69.1% (vs. exception for MFDS approval). The 10 areas of the clinical trial inspection checklist (reports, protection of subjects, compliance with protocols, records, management of investigational drug and/or device, delegation of duties, qualification of investigators, management of specimen, contract-agreement and approval of protocols, and preservation of recorded documents) were weighted between 2 to 5 points. The average of the total points was 16.09±13.2 and 20 clinical trials were above the average. As a result of comparing the average of the total points weighted by year, the highest score was in 2020. The 4 factors that play significant roles in determining the internal quality were (1) principal subjects that initiated the clinical trials (p=0.049), (2) type (p=0.003), (3) phase of clinical trials (p=0.024), and (4) number of registered subjects reported at the time of continuing deliberation (p=0.019). Of the 10 areas of the clinical trial inspection checklist, 'record' was the most inappropriate and insufficient. We found more indicated points; the quality of performance declined in IIT, nonclinical trials, and other clinical trials that were not in phase I1-IV4, and the study of more than 30 registered subjects at the time of continuing review. Conclusion: If an institution has an internal audit selection tool that reflects the aforementioned risk factors, it will be possible to effectively manage high-risk studies; thereby, contributing to an efficient internal audit and improving the quality of clinical trials.

• Journal of Sasang Constitutional Medicine
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• v.26 no.1
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• pp.45-54
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• 2014

Objectives This research was proposed to present Clinical Practice Guideline(CPG) for Soeumin Disease of Sasang Constitutional Medicine(SCM): Greater Yin Symptomatology. This CPG was developed by the national-wide experts committee consisting of SCM professors. Methods First, it was performed that search and collection of literature related SCM such as "Dongeuisusebowon", Textbook of SCM, Clinical Guidebook of SCM and Fundamental research to standardize diagnosis of Sasang Constitutional Medicine. And journal search related clinical trial or Human complementary medicine of SCM was performed domestic and overseas. Finally, 1 article was selected and included in CPG for Greater Yin Symptomatology of Stomach Cold-based Interior Cold disease in Soeumin disease. Results & Conclusions CPG of Greater Yin symptomatology in Soeumin Disease include classification, definition and standard symptoms of each pattern. Greater Yin symptomatology is classified into mild and moderate pattern by severity. Greater Yin Symptomatology Mild pattern is classified into Greater Yin Symptomatology accompanied abdominal pain and bowel irritability and Greater Yin pattern accompanied Epigastric stuffiness and fullness. And Greater Yin Symptomatology moderate pattern is classified into Greater Yin pattern accompanied Jaundice, Greater Yin pattern accompanied Edema and Greater Yin pattern by Yin toxin.

• Journal of Sasang Constitutional Medicine
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• v.26 no.1
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• pp.27-36
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• 2014

Objectives This research was proposed to present Clinical Practice Guideline(CPG) for Soeumin Disease of Sasang Constitutional Medicine(SCM): Congestive Hyperpsychotic symptomatology. This CPG was developed by the national-wide experts committee consisting of SCM professors. Methods First, it was performed that search and collection of literature related SCM such as "Dongeuisusebowon", Textbook of SCM, Clinical Guidebook of SCM and Fundamental research to standardize diagnosis of Sasang Constitutional Medicine. And journal search related clinical trial or Human complementary medicine of SCM was performed domestic and overseas. Finally, no article was selected and included in CPG for Congestive Hyperpsychotic symptomatology of Kidney Heat-based Exterior Heat disease in Soeumin disease. Results & Conclusions CPG of Congestive Hyperpsychotic symptomatology in Soeumin Disease include classification, definition and standard symptoms of each pattern. Congestive Hyperpsychotic symptomatology is classified into mild and severe pattern by severity. Congestive Hyperpsychotic symptomatology mild pattern is classified into initial pattern. Congestive Hyperpsychotic symptomatology severe pattern is classified into intermediate and advanced pattern and Greater Yang disease Reverting Yin pattern.

• The Journal of Korean Medicine
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• v.40 no.1
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• pp.124-152
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• 2019

Objectives: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer" by analyzing the existing guidelines and clinical trials. Methods: The development committee searched guidelines for herbal medicinal products for colorectal cancer that have already been developed. Then, clinical trials for colorectal cancer using herbal medicine were searched. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of our analysis with the regulations and guidelines of the Ministry of Food and Drug Safety in order to identify the issues we will have to consider when making the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer". Several guidelines for anti-tumor agents and clinical trials with herbal medicinal products were searched on the national institution homepage. In addition, 12 articles were searched using a combination of the following search terms: 'colorectal neoplasms', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional', 'medicine, East Asian medicine', 'medicine, Kampo', etc. Results: The characteristics of participants were various, such as people with medical histories of surgeries or recurrent cancers or who complained of chemotherapy-induced side effects. The types of interventions were also various and included decoctions, powders, intravenous fluids, intraperitoneal injections and gargles. Comparators used included placebos and conventional treatments. The outcome measurements used in the studies were quality of life, symptom score, tumor response, and survival duration, etc. Safety was evaluated by recording adverse events. Conclusions: Findings were made by reviewing existing guidelines and comparing them with clinical trials for colorectal cancer and herbal medicinal products. These results will be utilized in the development of the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer".

• Journal of Physiology & Pathology in Korean Medicine
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• v.28 no.6
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• pp.662-667
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• 2014

The purpose of this clinical study is to develop structured clinical trial protocol and guideline for improvement of safety, useful and effective of pulse diagnosis devices. As a first step, papers on pulse diagnosis and pulse diagnosis devices from 2001 and 2013 were systematically reviewed. In the next step, we have collected the opinions from the specialists, companies, and statistician in pulse diagnosis to evaluate the current condition, the state and problem of domestic clinical trial cases of pulse diagnosis device. And we have to created protocol and case report form (CRF) in regards to site condition and characteristics of pulse diagnosis devices, and showed the guideline of eligibility criteria, operation process, investigation items, evaluation items and so on. This clinical protocol will become a basic information for a researcher in designing or performing a clinical study of pulse diagnosis devices, and be used as a useful material during acquisition of good clinical data. Furthermore, we hope to enhance the invigoration of pulse diagnosis clinical trials and the performance improvement of pulse diagnosis devices.

• Journal of Korean Medicine Rehabilitation
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• v.27 no.4
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• pp.111-119
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• 2017

Objectives Clinical pathway (CP), is management plans that display goals for patients and have led to improve outcomes for many diseases. In Korea, Interest in Korean medicine's stabilization (Clinical pathway, Clinical Practice Guideline) is increasing, But the number of studies is scare. Method and Analysis This trials composes nonequivalent control group pretest-posttest design to conduct clincal pathway trial for the acute pain after back surgery. The subjects were 10 control patients with back surgery, and 10 experimental patients with application of integrative CP. Each group patient will observed 6 weeks. We check validation of CP. Also we compared the patient's status using the pain, function, Quality of life index between the two groups. Discussion This trial is the first CP for the acute pain after back surgery using integrative medicine concepts. Aim of this trial is to find the effectiveness and validity of clincal pathway for acute pain after back surgery.

• Korean Journal of Clinical Pharmacy
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• v.5 no.2
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• pp.33-49
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• 1995

The purpose of this study is to understand present situation of clinical trials, and evaluate the preparedness of the desiRnated institutions to abide by GCP(Good Clinical Practice) standards during clinical trials. Survey on the status of clinical trials was conducted for the desienated 83 clinical trial hospitals, and response rate was $95.2\%$. The results showed that 39 hospitals have conducted clinical trials to obtain drug manufacturing approval from 1990 to 1994. Most of them were trials on Phase III. Only $46.8\%$ of the institutions had sufficient human resources to perform the clinical trials. Institutions which established IRB(Institutional Review Board) accounted for 41 or $51.9\%$, but those who have a protocol evaluation guideline, or Adverse Drug Reaction(ADR) reporting system were only 12, and 21 Places, respectively. Regarding supervision of the investigational drugs, less than 30 institutions designated pharmacist as a supervisor. In conducting clinical trials, $97.4\%$ of trials had high rates of prior consent of testees, but only part of them-$61.7\%$-gave written consent. The level of conducting GCP is found to be unsatisfactory. Institutions must build the appropriate infrastructure and government must prepare in order to protect testees' rights as well as to ensure validity of the results.