Utilization of a Clinical Trial Management System for the Whole Clinical Trial Process as an Integrated Database: System Development.

BACKGROUND: Clinical trials pose potential risks in both communications and management due to the various stakeholders involved when performing clinical trials. The academic medical center has a responsibility and obligation to conduct and manage clinical trials while maintaining a sufficiently high level of quality, therefore it is necessary to build an information technology system to support standardized clinical trial processes and comply with relevant regulations. OBJECTIVE: The objective of the study was to address the challenges identified while performing clinical trials at an academic medical center, Asan Medical Center (AMC) in Korea, by developing and utilizing a clinical trial management system (CTMS) that complies with standardized processes from multiple departments or units, controlled vocabularies, security, and privacy regulations. METHODS: This study describes the methods, considerations, and recommendations for the development and utilization of the CTMS as a consolidated research database in an academic medical center. A task force was formed to define and standardize the clinical trial performance process at the site level. On the basis of the agreed standardized process, the CTMS was designed and developed as an all-in-one system complying with privacy and security regulations. RESULTS: In this study, the processes and standard mapped vocabularies of a clinical trial were established at the academic medical center. On the basis of these processes and vocabularies, a CTMS was built which interfaces with the existing trial systems such as the electronic institutional review board health information system, enterprise resource planning, and the barcode system. To protect patient data, the CTMS implements data governance and access rules, and excludes 21 personal health identifiers according to the Health Insurance Portability and Accountability Act (HIPAA) privacy rule and Korean privacy laws. Since December 2014, the CTMS has been successfully implemented and used by 881 internal and external users for managing 11,645 studies and 146,943 subjects. CONCLUSIONS: The CTMS was introduced in the Asan Medical Center to manage the large amounts of data involved with clinical trial operations. Inter- and intraunit control of data and resources can be easily conducted through the CTMS system. To our knowledge, this is the first CTMS developed in-house at an academic medical center side which can enhance the efficiency of clinical trial management in compliance with privacy and security laws.

Knowledge and Perception about Clinical Research Shapes Behavior: Face to Face Survey in Korean General Public.

Considering general public as potential patients, identifying factors that hinder public participation poses great importance, especially in a research environment where demands for clinical trial participants outpace the supply. Hence, the aim of this study was to evaluate knowledge and perception about clinical research in general public. A total of 400 Seoul residents with no previous experience of clinical trial participation were selected, as representative of population in Seoul in terms of age and sex. To minimize selection bias, every fifth passer-by was invited to interview, and if in a cluster, person on the very right side was asked. To ensure the uniform use of survey, written instructions have been added to the questionnaire. Followed by pilot test in 40 subjects, the survey was administered face-to-face in December 2014. To investigate how perception shapes behavior, we compared perception scores in those who expressed willingness to participate and those who did not. Remarkably higher percentage of responders stated that they have heard of clinical research, and knew someone who participated (both, P < 0.001) compared to India. Yet, the percentage of responders expressed willingness to participate was 39.3%, a significantly lower rate than the result of the India (58.9% vs. 39.3%, P < 0.001). Treatment benefit was the single most influential reason for participation, followed by financial gain. Concern about safety was the main reason for refusal, succeeded by fear and lack of trust. Public awareness and educational programs addressing these negative perceptions and lack of knowledge will be effective in enhancing public engaged in clinical research.

Process Innovation Improves Trial Operation Efficiency.

BACKGROUND: Despite the fact that unaddressed delays in clinical trial operation could severely compromise the overall effort invested, there seems to be a lack of concerted effort in reforming such delays. This study evaluated the composite effect of initiatives in reforming trial operation efficiency. METHODS: A high-volume academic medical center in Korea has implemented various initiatives to improve the trial operation efficiency by expediting times from institutional review board (IRB) submission to approval, from IRB submission to trial open for subject enrollment, and from trial open to first patient-in. The initiatives include implementation of the protocol preliminary review, parallel processing of the clinical trial agreement review in line with the protocol submission to the IRB, and involvement of project manager for operational risk management. Times from IRB submission to approval, from IRB submission to trial open, and from trial open to first patient-in before and after implementation of initiatives were compared. RESULTS: The median time required in IRB approval was meaningfully shorter in the postinitiative group (19 vs 14 days; P < .001). The median times from IRB submission to trial open for subject enrollment and from trial open to first patient-in were reduced significantly in the postinitiative group (trial open: 25 vs 18 days, P < .001; first patient-in: 111.5 vs 100 days, P = .014). CONCLUSIONS: The initiatives were effective in reforming trial operational efficiency. Additional studies to address the cause of operational delay and modifiable factors influencing subject enrollment are needed to further improve operational efficiency.

Prevalence of Helicobacter pylori infection and its association with cardiovascular risk factors in Korean adults.

OBJECTIVE: The purpose of this study is to evaluate the prevalence of Helicobacter pylori (H. pylori) infection and its association with cardiovascular risk factors in healthy Korean adults. In 58981 subjects who participated in health screening program, the proportion of seropositive subjects for H. pylori and its association with cardiovascular risk factors was evaluated. RESULTS: A total of 70.9% of participants were tested positive for the H. pylori antibody. The seropositivity was highest in the age group of 50 and 60 years old. More male subjects tended to be infected with H. pylori (p<0.05) than female subjects except for the age group of 50s. H. pylori seropositive subjects tended to be older than seronegative subjects (41.5 vs. 39.2 years old). After adjusting for age, H. pylori-seropositive group showed higher mean values for total cholesterol, triglyceride, low-density lipoprotein (LDL)-cholesterol, apolipoprotein B and lower values for high-density lipoprotein (HDL)-cholesterol, apolipoprotein A1 (p<0.05). In univariate correlation analysis, age, total cholesterol, LDL-cholesterol and apolipoprotein B were positively correlated and HDL-cholesterol and apolipoprotein A1 were negatively correlated with H. pylori immunoglobulin G (IgG) titers (p<0.05). The multiple analysis of covariance analysis (MANCOVA) for the H. pylori infection status showed triglyceride, HDL-cholesterol and apolipoproteins associated with H. pylori infection significantly (p<0.05). In the analysis performed only in the H. pylori-seropositive group, no difference between the groups with and without peptic ulcer were shown according to the risk factors except HDL-cholesterol (p=0.031). CONCLUSIONS: H. pylori infection is prevalent in Korean adults and is associated with cardiovascular risk factors, especially with triglyceride, HDL-cholesterol and apolipoproteins, independently from the presence of peptic ulcer. This is in line with the previous study results in which H. pylori infection per se might be one of the factors affecting atherosclerosis through modulation of lipid profiles, which needs further research.

Depressive mood and abdominal fat distribution in overweight premenopausal women.

OBJECTIVE: There is increasing evidence that depressive mood is associated with central obesity, but little is known about the association between depression and abdominal fat distribution. This study investigated this relationship in premenopausal women. RESEARCH METHODS AND PROCEDURES: We recruited 101 overweight premenopausal women who had no eating disorders as defined using the DSM IV criteria. Depressive mood was assessed using Zung's Self-Rating Depression Scale (SDS). Areas of visceral (VAT) and subcutaneous (SAT) adipose tissue at the level of vertebral body L(4)-L(5) were measured using computed tomography. Associations of VAT, SAT, and the ratio of VAT to SAT with natural logarithmic transformation [(ln)]SDS were evaluated using linear regression. Anthropometric indices and physical fitness were also measured. Information on socioeconomic status, education level, and alcohol and smoking habits was obtained using self-administered questionnaires. A hospital nutritionist assessed nutritional status. All of these factors were adjusted for as possible confounding factors in the analyses. RESULTS: The (ln)SDS score showed a positive association with the area of VAT, even after adjusting for the confounders mentioned above (p < 0.01). BMI, waist circumference, maximal oxygen uptake, and age were also associated with the area of VAT (all p < 0.05). In contrast, the (ln)SDS score was not associated with SAT (p > 0.10). DISCUSSION: We showed that depressive mood is associated with VAT, not with SAT, in overweight premenopausal women. These findings may explain some of the association between depression and coronary heart disease. More studies are needed to elucidate the causal relationship.

Incidence Density of Antibody against Hepatitis C Virus in Seoul and Gyeonggi Area; A Retrospective Cohort Study: Based on Medical Screening Data from a General Hospital.

OBJECTIVES: This study was performed to determine the incidence density and the prevalence of sero-positive hepatitis C from 1999 to 2002 among adults aged 20 and over residing in Seoul and the Gyeonggi province. METHODS: The data for period was obtained from 114, 635 adults, residing in Seoul or the Gyeonggi province, who had undertaken comprehensive health screening tests from Jan 1999 to Dec 2002 in a University hospital in Seoul. Among them, subjects with sero-negative status against hepatitis C were selected (21, 408 in 1999, 28, 830 in 2000) and then followed up until Dec 2002 to determine the incidence of hepatitis C during this period. The serum was tested with the immunoradiometric assay (IRMA) which uses third generation HCV antibody. Age adjusted rates were estimated by direct standardization using a reference population of 2000 aged from 20 to 80 years. RESULTS: The prevalence of anti-HCV from 1999 to 2002 was 2.1 per 1000 persons (95% CI 1.8~2.4). Male showed 1.7 per 1000 persons (95% CI 1.4~2.1), while female showed 2.7 per 1000 persons (95% CI 2.2~3.2). Age?sex adjusted rate showed 2.8 per 1000 persons (95% CI 2.64~2.96), which is lower than the results of some previous study. The prevalence showed a significantly increasing pattern with age both in males and females (p< 0.05). The incidence density of anti-HCV among the population aged 20 and over was 1.1 per 104 person-years at risk (95% CI 0.6~2.4) ; 1.2 (95% CI 0.6~2.7) for males and 0.8 (95% CI 0.6~4.2) for females. Age adjusted incidence density was 2.91 per 104 person-years at risk (95% CI 2.43~3.38) for those aged 20 and over. It showed an increasing pattern with age (p< 0.05), especially for those age over 50 years. CONCLUSIONS: The study subjects for this study were supposedly healthier than the general population so the prevalence and incidence for the general population are thought to be higher than the results of the present study.

Abdominal Obesity in Relation to the Incidence of Type 2 Diabetes Mellitus and Impaired Fasting Glucose among some Korean Adults: A Retrospective Cohort Study.

OBJECTIVES: This study was performed to determine whether an increase in abdominal obesity is an independent risk factor for impaired fasting glucose and type 2 DM. METHODS: Among 24, 212 adults over 30 years who undertook comprehensive medical screening examinations from Jan to Dec 1999, in a university hospital in Seoul, a total of 11, 183 subjects were selected who had no DM at baseline and who were followed up more than once by Dec 2002. The average follow up period was 2.4 (+/-0.5) years. DM was defined as having a fasting glucose level > or = 126mg/dl, and impaired fasting glucose as showing a fasting glucose level between 110 and 125 mg/dl. Body weight, height and waist circumference (WC) were simultaneously measured with blood sampling. The relative risks (RRs) for DM and impaired fasting glucose by WC were calculated using Cox proportional hazard model. Ageadjusted rates were estimated by direct standardization using a reference population of 2000 from 30 to 80 years. RESULTS: The average age of the subjects was 41.7 (+/- 7.0) years; males 41.2 (+/-6.5) and females 45.6 (+/-9.2). RRs for type 2 DM by WC with the reference group of WC < 80cm were as follows: 2.66 (95%, CI 0.55~12.8) for WC of 80~89cm in men, 5.92 (95%, CI 1.08~32.3) for WC > or = 90 cm in men, and 2.64 (95%, CI 0.23~29.8) for WC of 80~89cm in females. RRs for impaired fasting glucose by WC were 3.03 (95%, CI 2.18~4.22) for WC 80~89cm in men, 6.10 (95%, CI 4.25~8.75) for WC > or = 90cm in men, and 1.56 (95%, CI 0.43~5.67) for WC 80~89cm in women, and 8.08 (95%, CI 2.22~29.4) for WC > or = 90cm in females. These results remained significant after adjustment for age, BMI and fasting glucose concentrations at baseline in both sexes. Annual increment of more than 1 cm in WC was associated with the development of DM and impaired fasting glucose independently of age, sex, BMI, or presence of abdominal obesity. CONCLUSIONS: In Korean adults, abdominal obesity increased the risk for the development of type 2 diabetes and impaired fasting glucose. This result supports many other prospective studies suggesting abdominal obesity as a risk factor for type 2 diabetes.