Dataset Information

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

ABSTRACT: 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.

SUBMITTER: Park YR

PROVIDER: S-EPMC5941091 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Park Yu Rang YR Yoon Young Jo YJ Koo HaYeong H Yoo Soyoung S Choi Chang-Min CM Beck Sung-Ho SH Kim Tae Won TW

Journal of medical Internet research 20180424 4

<h4>Background</h4>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.<h4>Objective</h4>Th ...[more]

PMID: 29691212

Similar Datasets

Project description:Centralized outcome adjudication has been used widely in multicenter clinical trials in order to prevent potential biases and to reduce variations in important safety and efficacy outcome assessments. Adjudication procedures could vary significantly among different studies. In practice, the coordination of outcome adjudication procedures in many multicenter clinical trials remains as a manual process with low efficiency and high risk of delay. Motivated by the demands from two large clinical trial networks, a generic outcome adjudication module has been developed by the network's data management center within a homegrown clinical trial management system. In this article, the system design strategy and database structure are presented.A generic database model was created to transfer different adjudication procedures into a unified set of sequential adjudication steps. Each adjudication step was defined by one activate condition, one lock condition, one to five categorical data items to capture adjudication results, and one free text field for general comments. Based on this model, a generic outcome adjudication user interface and a generic data processing program were developed within a homegrown clinical trial management system to provide automated coordination of outcome adjudication.By the end of 2014, this generic outcome adjudication module had been implemented in 10 multicenter trials. A total of 29 adjudication procedures were defined with the number of adjudication steps varying from 1 to 7. The implementation of a new adjudication procedure in this generic module took an experienced programmer 1 or 2?days. A total of 7336 outcome events had been adjudicated and 16,235 adjudication step activities had been recorded. In a multicenter trial, 1144 safety outcome event submissions went through a three-step adjudication procedure and reported a median of 3.95?days from safety event case report form submission to adjudication completion. In another trial, 277 clinical outcome events were adjudicated by a six-step procedure and took a median of 23.84?days from outcome event case report form submission to adjudication procedure completion.A generic outcome adjudication module integrated in the clinical trial management system made the automated coordination of efficacy and safety outcome adjudication a reality.

Project description:Background Clinical research, particularly in scientific data, grapples with the efficient management of multimodal and longitudinal clinical data. Especially in neuroscience, the volume of heterogeneous longitudinal data challenges researchers. While current research data management systems offer rich functionality, they suffer from architectural complexity that makes them difficult to install and maintain and require extensive user training.Objectives The focus is the development and presentation of a data management approach specifically tailored for clinical researchers involved in active patient care, especially in the neuroscientific environment of German university hospitals. Our design considers the implementation of FAIR (Findable, Accessible, Interoperable, and Reusable) principles and the secure handling of sensitive data in compliance with the General Data Protection Regulation.Methods We introduce a streamlined database concept, featuring an intuitive graphical interface built on Hypertext Markup Language revision 5 (HTML5)/Cascading Style Sheets (CSS) technology. The system can be effortlessly deployed within local networks, that is, in Microsoft Windows 10 environments. Our design incorporates FAIR principles for effective data management. Moreover, we have streamlined data interchange through established standards like HL7 Clinical Document Architecture (CDA). To ensure data integrity, we have integrated real-time validation mechanisms that cover data type, plausibility, and Clinical Quality Language logic during data import and entry.Results We have developed and evaluated our concept with clinicians using a sample dataset of subjects who visited our memory clinic over a 3-year period and collected several multimodal clinical parameters. A notable advantage is the unified data matrix, which simplifies data aggregation, anonymization, and export. THIS STREAMLINES DATA EXCHANGE AND ENHANCES DATABASE INTEGRATION WITH PLATFORMS LIKE KONSTANZ INFORMATION MINER (KNIME): .Conclusion Our approach offers a significant advancement for capturing and managing clinical research data, specifically tailored for small-scale initiatives operating within limited information technology (IT) infrastructures. It is designed for immediate, hassle-free deployment by clinicians and researchers.The database template and precompiled versions of the user interface are available at: https://github.com/stebro01/research_database_sqlite_i2b2.git.

Project description:BACKGROUND:Uncontrolled asthma poses substantial negative personal and health system impacts. Web-based technologies, including smartphones, are novel means to enable evidence-based care and improve patient outcomes. OBJECTIVE:The aim of this study was to design, develop, and assess the utilization of an asthma collaborative self-management (CSM) platform (breathe) using content based on international evidence-based clinical guidelines. METHODS:We designed and developed breathe as a Web-based mobile health (mHealth) platform accessible on smartphones, tablets, or desktop with user-centered design methods and International Organization for Standardization-certified quality development processes. Moreover, breathe was envisioned as a multifunctional, CSM mHealth platform, with content based on international clinical practice guidelines and compliant with national privacy and security specifications. The system enabled CSM (patient, provider, and breathe) and self-monitoring of asthma patients through (1) assessment of asthma control, (2) real-time access to a dynamic asthma action plan, (3) access to real-time environmental conditions, and (4) risk-reduction messaging. The data collection protocol collected user data for 12 months, with clinic visits at baseline and 6 and 12 months. Utilization outcomes included user interactions with the platform, user impressions, self-reported medication use, asthma symptom profile, reported peak flow measurement, and the delivery and impact of email reminders. RESULTS:We enrolled 138 patients with a mean age of 45.3 years to receive the breathe intervention. Majority were female (100/138, 72.5%), had a smartphone (92/138, 66.7%), and had a mean Asthma Control Test score of 18.3 (SD 4.9). A majority reported that breathe helped in the management of their asthma. Moreover, breathe scored 71.1 (SD 18.9) on the System Usability Scale. Overall, 123 patients had complete usage analytics datasets. The platform sent 7.96 reminder emails per patient per week (pppw), patients accessed breathe 3.08 times, journaled symptoms 2.56 times, reported medication usage 0.30 times, and reported peak flow measurements 0.92 times pppw. Furthermore, breathe calculated patients' action plan zone of control 2.72 times pppw, with patients being in the green (well-controlled) zone in 47.71% (8300/17,396) of the total calculations. Usage analysis showed that 67.5% (83/123) of the participants used the app at week 4 and only 57.7% (71/123) by week 45. Physician visits, email reminders, and aged 50 years and above were associated with higher utilization. CONCLUSIONS:Individuals with asthma reported good usability and high satisfaction levels, reacted to breathe notifications, and had confidence in the platform's assessment of asthma control. Strong utilization was seen at the intervention's initiation, followed by a rapid reduction in use. Patient reminders, physician visits, and being aged 50 years and above were associated with higher utilization. TRIAL REGISTRATION:ClinicalTrials.gov NCT01964469; https://clinicaltrials.gov/ct2/show/NCT01964469.

Project description:BACKGROUND:Advances in mobile health (mHealth) have enabled systematic and continuous management of patients with chronic diseases. OBJECTIVE:We developed a smartphone-based mHealth system and aimed to evaluate its effects on health behavior management and risk factor control in stroke patients. METHODS:With a multifaceted stroke aftercare management system that included exercise, medication, and educational materials, we performed a 12-week single-arm intervention among eligible poststroke patients in the stroke clinic from September to December 2016. The intervention consisted of (1) regular blood pressure (BP), blood glucose, and physical activity measurements; (2) stroke education; (3) an exercise program; (4) a medication program; and (5) feedback on reviewing of records by clinicians. Clinical assessments consisted of the stroke awareness score, Beck Depression Inventory-II (BDI), EuroQol-5 Dimensions (EQ-5D), and BP at visit 1 (baseline), visit 2 (4 weeks), and visit 3 (12 weeks). Temporal differences in the parameters over 12 weeks were investigated with repeated-measures analysis of variance. Changes in medication adherence at visit 1-2 (from visit 1 to visit 2) and visit 2-3 (from visit 2 to visit 3) were compared. System satisfaction was evaluated with a self-questionnaire using a 5-point Likert scale at visit 3. RESULTS:The study was approved by the Institutional Review Board in September 2016, and participants were enrolled from September to December 2016. Among the 110 patients enrolled for the study, 99 were included in our analyses. The mean stroke awareness score (baseline: 59.6 [SD 18.1]; 4 weeks: 67.6 [SD 16.0], P<.001; 12 weeks: 74.7 [SD 14.0], P<.001) and BDI score (baseline: 12.7 [SD 10.1]; 4 weeks: 11.2 [SD 10.2], P=.01; 12 weeks: 10.7 [SD 10.2], P<.001) showed gradual improvement; however, no significant differences were found in the mean EQ-5D score (baseline: 0.66 [SD 0.33]; 4 weeks: 0.69 [SD 0.34], P=.01; 12 weeks: 0.69 [SD 0.34], P<.001). Twenty-six patients who had uncontrolled BP at baseline had -13.92 mmHg (P=.001) and -6.19 mmHg (P<.001) reductions on average in systolic and diastolic BP, respectively, without any antihypertensive medication change. Medication compliance was better at visit 2-3 (60.9% [SD 37.2%]) than at visit 1-2 (47.8% [SD 38.7%], P<.001). CONCLUSIONS:Awareness of stroke, depression, and BP was enhanced when using the smartphone-based mHealth system. Emerging mHealth techniques have potential as new nonpharmacological secondary prevention methods because of their ubiquitous access, near real-time responsiveness, and comparatively lower cost.

Project description:ImportanceOnline programs may help with weight loss but have not been widely implemented in routine primary care.ObjectiveTo compare the effectiveness of a combined intervention, including an online weight management program plus population health management, with the online program only and with usual care.Design, setting, and participantsCluster randomized trial with enrollment from July 19, 2016, through August 10, 2017, at 15 primary care practices in the US. Eligible participants had a scheduled primary care visit and were aged 20 to 70 years, had a body mass index between 27 and less than 40, and had a diagnosis of hypertension or type 2 diabetes. Follow-up ended on May 8, 2019.InterventionsParticipants in the usual care group (n = 326) were mailed general information about weight management. Participants in the online program only group (n = 216) and the combined intervention group (n = 298) were registered for the online program. The participants in the combined intervention group also received weight-related population health management, which included additional support from nonclinical staff who monitored their progress in the online program and conducted periodic outreach.Main outcomes and measuresThe primary outcome was weight change at 12 months based on measured weights recorded in the electronic health record. Weight change at 18 months was a secondary outcome.ResultsAmong the 840 participants who enrolled (mean age, 59.3 years [SD, 8.6 years]; 60% female; 76.8% White), 732 (87.1%) had a recorded weight at 12 months and the missing weights for the remaining participants were imputed. There was a significant difference in weight change at 12 months by group with a mean weight change of -1.2 kg (95% CI, -2.1 to -0.3 kg) in the usual care group, -1.9 kg (95% CI, -2.6 to -1.1 kg) in the online program only group, and -3.1 kg (95% CI, -3.7 to -2.5 kg) in the combined intervention group (P < .001). The difference in weight change between the combined intervention group and the usual care group was -1.9 kg (97.5% CI, -2.9 to -0.9 kg; P < .001) and the difference between the combined intervention group and the online program only group was -1.2 kg (95% CI, -2.2 to -0.3 kg; P = .01). At 18 months, the mean weight change was -1.9 kg (95% CI, -2.8 to -1.0 kg) in the usual care group, -1.1 kg (95% CI, -2.0 to -0.3 kg) in the online program only group, and -2.8 kg (95% CI, -3.5 to -2.0 kg) in the combined intervention group (P < .001).Conclusions and relevanceAmong primary care patients with overweight or obesity and hypertension or type 2 diabetes, combining population health management with an online program resulted in a small but statistically significant greater weight loss at 12 months compared with usual care or the online program only. Further research is needed to understand the generalizability, scalability, and durability of these findings.Trial registrationClinicalTrials.gov Identifier: NCT02656693.

Project description:PurposeWhile in the past, most clinical trial applications (CTAs) following non-integrated (standard) protocols were used to investigate one primary objective concerning a (new) drug, nowadays, the use of integrated protocols investigating multiple objectives within the same CTA becomes more and more popular. The aims of the present study were to investigate the usage and the impact of integrated protocols on regulatory activities and to find the motivation for their increasing use.MethodsTwo thousand nine hundred sixty-nine phase I and I/II CTAs submitted to the German Federal Institute for Drugs and Medical Devices (BfArM) during the time period from August 1, 2004, until August 31, 2014, were analysed with regard to protocol and sponsor status, duration until initial authorisation and the number of substantial amendments and their respective approval times. Additionally, applicants who submitted integrated protocols to BfArM were interviewed with respect to their opinion on integrated protocols in an online survey.ResultsThe percentage of integrated protocols has constantly increased by approximately 10% within the last 10 years from 17.9% in 2004 to 28.2% in 2014. It could be shown that authorisation procedures with single integrated protocols take significantly longer until initial authorisation (58 vs. 53 days) requires more substantial amendments (1.9 vs. 1.2 amendments per CTA) and the approval of the entirety of amendments takes longer to process as compared to standard protocols (22 vs. 14 days). Nevertheless, applicants prefer the use of integrated protocols due to higher time and cost economy for the entire phase I development process.ConclusionAlthough clinical trials (CTs) following integrated protocols are partly more time-consuming and costly, still, time and/or money may be saved during drug development due to the fact that overall, fewer CTs are needed than with standard protocols. Hence, the main reason for the increasing use of integrated protocols is improved time and cost efficiencies when conducting CTs.

Dataset Information

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

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets