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Inhibitory Effects of 6-Gingerol on Cytochrome P450 in Human Liver Microsomes.

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2011;19(1):52-58.

No abstract available.
Catechols ; Cytochrome P-450 Enzyme System ; Cytochromes ; Fatty Alcohols ; Humans ; Liver ; Microsomes, Liver

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Current Status of Clinical Research Coordinator's Employment.

Ihn Sook JEONG ; Sangmin CHOE ; Ji Hong SHON ; Won Ock KIM

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2011;19(1):40-51.

BACKGROUND: This study was aimed to investigate the current two years' clinical research coordinators (CRCs) employment and estimate total number of CRCs in Korea. METHODS: The participants were administrative officers or head CRCs in institutions designated by Korea Food & Drug Administration (KFDA). Data on the current status of CRCs' employment was collected with self-administered questionnaires or telephone interview. And total number of CRCs in Korea was estimated based on ratio between the number of the KFDA approved clinical trials and current number of CRCs. RESULTS: The number of CRCs was 1381 at 36 centers in 2009 and 1444 at 37 centers in 2010. About 79 percent of CRCs were employed by investigators. The estimated number of CRCs was from 1677 to 1763 at 135 centers in 2009 and from 1802 to 1890 at 142 centers in 2010 based on number of clinical trials approved by KFDA. Two third of regional clinical trial centers (RCTCs) had written employment policy, and 25 percent of RCTCs employed CRCs in a regular position. All RCTCs had educational programs for CRCs and supported CRCs for training outside. 75 percent of RCTCs provided ID card for CRCs belonging to investigators to access to hospital document. Half of RCTCs had CRC registration system in hospital-wide. CONCLUSION: The number of CRCs in Korea can be easily estimated with the number of KFDA approved clinical trials. Majority of RCTCs still employed CRCs in an irregular position, which should be switched to regular position to reduce the CRCs' unsatisfaction. It is also needed to develop centralized CRC management system for CRCs belonging to investigators.
Calcium Hydroxide ; Employment ; Head ; Humans ; Interviews as Topic ; Korea ; Surveys and Questionnaires ; Research Personnel ; Zinc Oxide

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Bioequivalence Study of Two Orally Disintegrating Risperidone Formulations, Risperdal OD(R) Tablet 1mg and Risperdal Quicklet(R) Tablet 1mg in Healthy Korean Volunteers.

Gaeun KANG ; Jin KIM ; Kyung Yeol BAE ; Hee Young SHIN ; Seong Wook JEONG ; Jin Sang YOON ; Jong Keun KIM

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2011;19(1):31-39.

BACKGROUND: Risperidone is one of the atypical antipsychotic drugs that have effectiveness in the management of a range of psychiatric illnesses. Orally disintegrating (OD) formulations of risperidone that rapidly dissolve in the mouth, prior to swallowing without water have been developed to overcome any problems related to swallowing and improve acceptability. The goal of this study was to evaluate the bioequivalence of Risperdal OD(R) tablet 1mg and Quicklet(R) tablet 1mg. METHODS: This randomized, open-label, 2-way crossover trial was conducted in 36 healthy male volunteers that received OD risperidone tablet, either the reference formulation (Risperdal Quicklet(R) tablet 1mg), or the test formulation (Risperdal OD(R) tablet 1mg), each in a single administration. Blood samples were obtained during a 24-hour period after dosing. Plasma was analyzed for risperidone by a validated LC-MS/MS. Adverse events were monitored by safety assessments including clinical interview by clinician. Pharmacokinetics were calculated by noncompartmental analysis and compared between two formulations. RESULTS: A total of 36 male volunteers (mean age, 24.2 years; height 174.5 cm; weight 67.6 kg) completed the study. The ANOVA showed no significant effect of sequence, formulation and period of Ln (AUClast) and Ln (Cmax). The 90% confidence intervals for the mean treatment ratios of the Ln (AUClast) and Ln (Cmax) were Ln 0.96 ~ Ln 1.12, Ln 0.97 ~ Ln 1.16, respectively. No serious adverse events were caused by both formulations. CONCLUSION: In this study, a single administration of Risperdal OD(R) tablet 1mg was bioequivalent to a single administration of Risperdal Quicklet(R) tablet 1mg.
Antipsychotic Agents ; Deglutition ; Humans ; Male ; Mouth ; Plasma ; Risperidone ; Therapeutic Equivalency

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Recognition of Clinical Research Coordinators among Non-Nursing Major Students.

Ihn sook JEONG

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2011;19(1):23-30.

BACKGROUND: This study was aimed to investigate recognition of clinical research coordinators (CRCs) among non-nursing major students. METHODS: The participants were 424 undergraduate or graduate students whose majors were related to life science, physical therapy or pharmaceutical engineering in three universities located in Busan. Data were collected with self administrated questionnaire including general characteristics (5 items), and recognition of CRCs (4 items). The collected data were coded and was analyzed using SPSS Version 18.0 for Windows for frequency and percentage, or mean and standard deviation. The Chi-squared test was used to assess the relationship between general characteristics and recognition of CRCs. All statistical tests were performed at the 0.05 level of significance for two-tailed tests. RESULTS: The percent of 'ever having heard of CRCs' was 28.3 % and 35.0 % of them showed the intention to work as CRCs. The 'ever having heard of CRCs' was related to major (p<0.001) and 'ever having heard of clinical trials' (p<0.001). The intention to work as CRCs was not related to gender, education, major, and 'ever having heard of clinical trials'. CONCLUSION: The level of 'ever having heard of CRCs' among non-nursing major students was lower than that of nurses. It is needed that more active introduction or promotion of CRCs to non-nursing major students through both regular curriculum or training programs. And it is also recommended to develop the job description for CRCs with nurse license or CRCs without nurse license.
Biological Science Disciplines ; Calcium Hydroxide ; Curriculum ; Humans ; Intention ; Job Description ; Licensure ; Surveys and Questionnaires ; Zinc Oxide

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Reasons for Investigators to Participate Industry Sponsored Clinical Trials.

Joon Hyung KIM ; Won CHOI ; Sung Ho BECK ; Soo Jeong PARK ; Soo Yeon PARK ; Woo Yun SOHN ; Hyun Ho KIM ; Seung Soo KIM ; Hankyu LEE ; Jung Ryun AHN ; Yoon Jung KIM ; Jung Min SEO ; Chung Mo NAM ; Yil Seob LEE

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2011;19(1):14-22.

BACKGROUND: It is getting more difficult to involve appropriate investigators in clinical trials. Knowing what investigators want from sponsor initiated clinical trials would help industry cooperate with investigators more efficiently. This study aims to describe the incentives for investigators choosing to participate or not and perform well in sponsored clinical trials. METHODS: Investigators who have participated in GSK sponsored clinical trials were interviewed face-to-face or through e-mail using the standardized questionnaire. Investigators were asked to choose five items and determine the ranking or those five items. RESULTS: Questionnaires answered by 122 investigators were collected. The top three incentives were "Academic merit" (108, 88.5 %), "Expectation of treatment potentially helpful to patient" (101, 82.8 %), and "Access to new treatments" (92, 75.4 %). The disincentives and the factors affecting an investigator's performance were analyzed separately because of the different questionnaire between investigators for medicine and vaccine. Investigators for medicine choose as disincentives "Insufficient time" (43, 61.4 %), "Difficult protocol" (41, 58.6 %), and "Adverse event concerns" (41, 58.6 %). Vaccine investigators pointed out "Limited support staff" (41, 78.8 %), "Insufficient time" (40, 76.9 %), and "Difficult blood sampling" (333, 63.5 %) as disincentives. Factors adversely affecting an investigator's performance showed similar results to those of disincentives. CONCLUSION: Investigators focused on academic curiosity and patients and insufficient time mostly inhibits them from participating and performing clinical trials. Our results would help industry cooperate with investigators more efficiently, finally making companies perform clinical trials more effectively.
Electronic Mail ; Exploratory Behavior ; Humans ; Motivation ; Surveys and Questionnaires ; Research Personnel

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The Suggestions for Improving the Institutional Review Board (IRB) in Clinical Trials: Focusing on Continuing Management.

Hee Young SHIN

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2011;19(1):5-13.

As Korea has increasing number of clinical trials in recent years, institutional review boards (IRBs) are facing new challenges. The IRB should review submitted documents and supervise clinical trials from the beginning to the end to protect human subjects. Although most IRBs invest much time and efforts to initial review, they rarely conduct proper continuing management at the moment. The purpose of this article is to describe challenges involving continuing management, which includes unanticipated problems, subject's complaints, site visit, and continuing review, and to provide suggestions for improving it. Above all, institutions should perceive the importance of continuing management and they should provide sufficient manpower and resources for the management.
Ethics Committees, Research ; Ethics, Research ; Humans ; Korea

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Post-marketing Surveillance of the Safety of Dutasteride Prescribed to Korean Patients with Benign Prostate Hyperplasia.

Joon Hyung KIM ; Ji Young BAE ; Shin Young OH ; Yil Seob LEE

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2012;20(1):85-94. doi:10.12793/jkscpt.2012.20.1.85

BACKGROUND: Dutasteride is an inhibitor of both types I and II 5 alpha-reductase and was approved in Korea in April 2004. This post-marketing surveillance was to assess the safety of dutasteride in Korean patients with benign prostate hyperplasia in real life and to elucidate the risk factors related adverse events. METHODS: From December 2004 to January 2010, 3,977 patients were enrolled by 184 urologists. According to post-marketing surveillance regulation, patients were enrolled consecutively. Patients administered dutasteride at least once were included in safety assessment. The incidences of any adverse events and serious adverse events were evaluated. Multiple logistic regression method was used to identify risk factors related to adverse events. RESULTS: The safety assessment included 3,870 patients with the mean age of 67.3 years. The incidence of adverse events was 3.8 %. The most frequent adverse event was impotence (75 cases, 1.9 %), libido decrease (49 cases, 1.3 %), ejaculation disorder (30 cases, 0.8 %), and gynecomastia (5 cases, 0.1 %). The incidence of unexpected adverse events was 0.5 % and cerebral infarction, lung cancer, pulmonary embolism, and diarrhea were reported as serious adverse events. CONCLUSION: In this survey, impotence was the most frequently reported adverse events. Dutasteride was well tolerated in Korean patients with benign prostate hyperplasia. These results updated the safety information and would provide important additional information for prescribers.
Azasteroids ; Cerebral Infarction ; Cholestenone 5 alpha-Reductase ; Diarrhea ; Drug Toxicity ; Dutasteride ; Ejaculation ; Erectile Dysfunction ; Gynecomastia ; Humans ; Hyperplasia ; Incidence ; Korea ; Libido ; Logistic Models ; Lung Neoplasms ; Male ; Prostate ; Pulmonary Embolism ; Risk Factors

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Proposal of Suitable On-the-Job Training for Clinical Research Coordinator in Korea.

Hongmo AN ; Hyunjung SHIN ; Eunji LEE ; Mijung KIM ; Eunhwa CHOI ; Jae Wook KO

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2012;20(1):74-84. doi:10.12793/jkscpt.2012.20.1.74

BACKGROUND: This study is intended to propose not only to introduce and evaluate the 2 years Clinical Research Coordinator (CRC) professional on-the-job training program that has been implemented in Samsung Medical Center on September of 2009, but also to develop the CRC future education program. METHODS: It is surveyed with self-report type for the 53 trainees, 18 non-trainees, and 17 investigators, the participants worked in Samsung Medical Center, and the major contents of the survey were general characteristics, training program evaluations, CRC qualification evaluation, and job satisfaction. The collected data was analyzed at the 0.05 level of significance by using SAS 9.1 version. RESULTS: The training program is conducted as 4 phases, each phase assessed separately. The Professional A course got the highest satisfaction, and it was deal with quality control (Mean=4.11 ~ 4.33). Most of the investigators answered that the trainees have high priority to be hired in the future (very much=82.45). The non-trainees answered that the training program would be helpful to improve the job competency and qualification (very much=22.2 %, somewhat=55.6 %) and 88.9 % of them answered that they have intention to participate in the training program. Finally, compared to non-trainees, the trainees have more job attachment (P=0.0036) and intention to continue CRC (P=0.0045). CONCLUSION: The CRC professional training program in Samsung Medical Center, as on the job training for 2 years, satisfies the investigators and trainees with positive effect on CRC job satisfaction and job stability. Based on this study, the education program with good quality should be developed considering the characteristics for each institution and close research field.
Humans ; Inservice Training ; Intention ; Job Satisfaction ; Korea ; Phenothiazines ; Quality Control ; Research Personnel

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Perception on Working Conditions and Utilization of Clinical Research Coordinators among Investigators and Sponsors.

Ihn Sook JEONG ; Sangmin CHOE ; Ji Hyang YOON ; Eun Hwa YUN

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2012;20(1):60-73. doi:10.12793/jkscpt.2012.20.1.60

BACKGROUND: This study was aimed to investigate the perception on working conditions and utilization of clinical research coordinators (CRCs) among investigators and sponsors. METHODS: The participants of this cross-section study were 114 investigators and 138 sponsors including clinical research associates (CRAs) who have worked with CRCs. Data was collected with paper or electronic form of self-administered questionnaires and analyzed with descriptive statistics and chi2 test or t test. RESULTS: Among investigators and sponsors, 56.1 % and 95.0 % perceived regular full-time positions as proper type of CRC employment, respectively. Those who perceived monthly salary with incentive as proper payment system were 67.5 % of investigators and 68.8 % of sponsors. The proper salary for 2-year CRCs and 5-year CRCs were significantly higher in sponsors than investigators. Investigators perceived CRCs could handle 3 studies as the same time and 5 studies per year. In regard to the difficulty in utilizing CRCs, 68.4 % of investigators perceived lack of experienced CRCs and 84.8 % of sponsors did frequent turnover. Those who responded pooling CRCs by hospital or clinical trial centers as a good solution to hire CRCs easily were 81.6 % of investigators and 58.0 % of sponsors. CONCLUSION: Almost all investigators and sponsors perceived CRCs were helpful for improving the quality of clinical trials. We recommend each institution or clinical trial centers could introduce the central CRCs' employment and management with proper salary and workload based on the results to maintain experienced CRCs and lessen the turnover of CRCs.
Calcium Hydroxide ; Electronics ; Electrons ; Employment ; Humans ; Motivation ; Surveys and Questionnaires ; Research Personnel ; Salaries and Fringe Benefits ; Zinc Oxide

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The Development of Automated Bed-allocation Expert System in Clinical Research Ward.

Seung Mi SONG ; Jong Myoung KIM ; Jong Lyul GHIM ; Jae Gook SHIN ; Eun Young KIM

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2012;20(1):51-59. doi:10.12793/jkscpt.2012.20.1.51

BACKGROUND: Demands for complicated and long-term administration clinical trials have been increased since investigators actively involved in early stage clinical trials including first-in-human (FIH) trials. Research wards in our clinical trial center were mainly used for phase 1 trials. In order to perform several clinical trials simultaneously during a short period with a minimum number of rooms, beds, and equipment, staffs have to spend a lot of time for efficient operation of limited numbers of facilities. In this study, automated bed-allocation system was developed for efficient scheduling of the research ward based on clinical trial condition and status like experts. METHODS: The system was developed based on clinical trial design, schedule, and the information on research bed and availability stored and updated in database (DB). Automatic assignment system was designed to find an optimal schedule according to the given information using expert rules and algorithms. The optimal solution can be visualized on Gantt chart using C# and Chart FX API. RESULTS: The system was developed to demonstrate the schedule on color chart. It turned out to be well-designed to find an optimal schedule for bed allocation. The system also allows automatic updating of the schedule and information in the DB. CONCLUSION: Automated bed-allocation system developed in this study could save time and improve the efficiency for using space and equipment in clinical trial center. The system can be also applied to similar works or tasks in other fields.
Appointments and Schedules ; Expert Systems ; Humans ; Research Personnel

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