scholarly journals Utilization of a Clinical Trial Management System for the Whole Clinical Trial Process as an Integrated Database: System Development (Preprint)

2017 ◽  
Author(s):  
Yu Rang Park ◽  
Young Jo Yoon ◽  
HaYeong Koo ◽  
Soyoung Yoo ◽  
Chang-Min Choi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Management System ◽  
Medical Center ◽  
Academic Medical Center ◽  
Trial Management ◽  
Privacy And Security ◽  
Academic Medical ◽  
Asan Medical ◽  
Clinical Trial Management

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.

Accelerating the clinical trial start-up process for early-phase cancer studies: A test of process change to support rapid activation in an academic medical center.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e17507-e17507 ◽  
Author(s):  
Sheilah K Hurley ◽  
Therica M Miller ◽  
Rebecca Flores Stella ◽  
Keren Dunn ◽  
Ryan Schroeder ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Center ◽  
Academic Medical Center ◽  
Cancer Center ◽  
Small Series ◽  
Academic Medical ◽  
One Year ◽  
Activation Times ◽  
High Level

e17507 Background: Clinical trial sponsors have strong scientific, financial, and regulatory interests in rapidly activating studies at participating sites. Academic medical centers have difficulty activating trials within a few weeks of sponsor agreement because, among other inefficiencies, they engage the necessary committee reviews, regulatory approvals, contracting, and budgeting in serial fashion. Incremental revisions in such workflows do not result in strong improvements. Methods: We redesigned our institutional workflow to complete clinical trial activation tasks within six weeks. Historical procedures were replaced rather than scrutinized. A high level leadership committee was required to change and integrate procedures across the medical center, and engage sponsors to improve their turnaround times. A web-based collaborative workflow tracking tool was created to help coordinate the necessary tasks and measure performance. Six clinical trials from the Cancer Center portfolio were used to test and improve the new workflow. Results: Clinical trial activation redesign took one year. For the six studies used as tests of change, the activation times were 49, 54, 78, 58, 62, and 32 days. Times in excess of 6 weeks were largely due to sponsor delays. Conclusions: Considerable effort is required to significantly alter a complex workflow like clinical trial activation. Appropriate priorities, leadership, staffing, and tools are required. Markedly shortened study activation for a small series of cancer trials taught our academic medical center lessons that will be useful for improving the process for all clinical trials, and will make us a better partner for pharmaceutical and academic sponsors as well as for investigator initiated research. [Table: see text]

scholarly journals The first step to the powers for clinical trials: a survey on the current and future Clinical Trial Management System

2018 ◽  
Vol 26 (2) ◽  
pp. 86
Author(s):  
Jin-Sol Park ◽  
Seol Ju Moon ◽  
Ji-Hyoung Lee ◽  
Ji-Young Jeon ◽  
Kyungho Jang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Management System ◽  
Future Clinical Trial ◽  
Trial Management ◽  
Clinical Trial Management

scholarly journals The Successful Synchronized Orchestration of an Investigator-Initiated Multicenter Trial Using a Clinical Trial Management System and Team Approach: Design and Utility Study (Preprint)

2021 ◽  
Author(s):  
Dinesh Pal Mudaranthakam ◽  
Alexandra Brown ◽  
Elizabeth Kerling ◽  
Susan E Carlson ◽  
Christina J Valentine ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Management System ◽  
Data Science ◽  
Medical Center ◽  
Phase 1 ◽  
Regulatory Compliance ◽  
Team Approach ◽  
Research Information ◽  
Trial Management ◽  
Clinical Trial Management

BACKGROUND As the cost of clinical trials continues to rise, novel approaches are required to ensure ethical allocation of resources. Multisite trials have been increasingly utilized in phase 1 trials for rare diseases and in phase 2 and 3 trials to meet accrual needs. The benefits of multisite trials include easier patient recruitment, expanded generalizability, and more robust statistical analyses. However, there are several problems more likely to arise in multisite trials, including accrual inequality, protocol nonadherence, data entry mistakes, and data integration difficulties. OBJECTIVE The Biostatistics & Data Science department at the University of Kansas Medical Center developed a clinical trial management system (comprehensive research information system [CRIS]) specifically designed to streamline multisite clinical trial management. METHODS A National Institute of Child Health and Human Development–funded phase 3 trial, the ADORE (assessment of docosahexaenoic acid [DHA] on reducing early preterm birth) trial fully utilized CRIS to provide automated accrual reports, centralize data capture, automate trial completion reports, and streamline data harmonization. RESULTS Using the ADORE trial as an example, we describe the utility of CRIS in database design, regulatory compliance, training standardization, study management, and automated reporting. Our goal is to continue to build a CRIS through use in subsequent multisite trials. Reports generated to suit the needs of future studies will be available as templates. CONCLUSIONS The implementation of similar tools and systems could provide significant cost-saving and operational benefit to multisite trials. CLINICALTRIAL ClinicalTrials.gov NCT02626299; https://tinyurl.com/j6erphcj

scholarly journals Rapid development of telehealth capabilities within pediatric patient portal infrastructure for COVID-19 care: barriers, solutions, results

2020 ◽  
Vol 27 (7) ◽  
pp. 1116-1120 ◽  
Author(s):  
Pious D Patel ◽  
Jared Cobb ◽  
Deidre Wright ◽  
Robert W Turer ◽  
Tiffany Jordan ◽  
...  
Keyword(s):  
Pediatric Patients ◽  
Medical Center ◽  
Rapid Development ◽  
Academic Medical Center ◽  
Security Policies ◽  
Patient Portal ◽  
Privacy And Security ◽  
Academic Medical ◽  
Adolescent Autonomy ◽  
National Emergency

Abstract The COVID-19 national emergency has led to surging care demand and the need for unprecedented telehealth expansion. Rapid telehealth expansion can be especially complex for pediatric patients. From the experience of a large academic medical center, this report describes a pathway for efficiently increasing capacity of remote pediatric enrollment for telehealth while fulfilling privacy, security, and convenience concerns. The design and implementation of the process took 2 days. Five process requirements were identified: efficient enrollment, remote ability to establish parentage, minimal additional work for application processing, compliance with guidelines for adolescent autonomy, and compliance with institutional privacy and security policies. Weekly enrollment subsequently increased 10-fold for children (age 0–12 years) and 1.2-fold for adolescents (age 13–17 years). Weekly telehealth visits increased 200-fold for children and 90-fold for adolescents. The obstacles and solutions presented in this report can provide guidance to health systems for similar challenges during the COVID-19 response and future disasters.

scholarly journals Expedited Safety Reporting Through an Alert System for Clinical Trial Management at an Academic Medical Center: Retrospective Design Study (Preprint)

2019 ◽  
Author(s):  
Yu Rang Park ◽  
HaYeong Koo ◽  
Young-Kwang Yoon ◽  
Sumi Park ◽  
Young-Suk Lim ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
High Risk ◽  
Performance Indicators ◽  
Phase 1 ◽  
Low Risk ◽  
Alert System ◽  
Trial Management ◽  
Safety Reporting ◽  
Clinical Trial Management

BACKGROUND Early detection or notification of adverse event (AE) occurrences during clinical trials is essential to ensure patient safety. Clinical trials take advantage of innovative strategies, clinical designs, and state-of-the-art technologies to evaluate efficacy and safety, however, early awareness of AE occurrences by investigators still needs to be systematically improved. OBJECTIVE This study aimed to build a system to promptly inform investigators when clinical trial participants make unscheduled visits to the emergency room or other departments within the hospital. METHODS We developed the Adverse Event Awareness System (AEAS), which promptly informs investigators and study coordinators of AE occurrences by automatically sending text messages when study participants make unscheduled visits to the emergency department or other clinics at our center. We established the AEAS in July 2015 in the clinical trial management system. We compared the AE reporting timeline data of 305 AE occurrences from 74 clinical trials between the preinitiative period (December 2014-June 2015) and the postinitiative period (July 2015-June 2016) in terms of three AE awareness performance indicators: onset to awareness, awareness to reporting, and onset to reporting. RESULTS A total of 305 initial AE reports from 74 clinical trials were included. All three AE awareness performance indicators were significantly lower in the postinitiative period. Specifically, the onset-to-reporting times were significantly shorter in the postinitiative period (median 1 day [IQR 0-1], mean rank 140.04 [SD 75.35]) than in the preinitiative period (median 1 day [IQR 0-4], mean rank 173.82 [SD 91.07], <i>P</i>≤.001). In the phase subgroup analysis, the awareness-to-reporting and onset-to-reporting indicators of phase 1 studies were significantly lower in the postinitiative than in the preinitiative period (preinitiative: median 1 day, mean rank of awareness to reporting 47.94, vs postinitiative: median 0 days, mean rank of awareness to reporting 35.75, <i>P</i>=.01; and preinitiative: median 1 day, mean rank of onset to reporting 47.4, vs postinitiative: median 1 day, mean rank of onset to reporting 35.99, <i>P</i>=.03). The risk-level subgroup analysis found that the onset-to-reporting time for low- and high-risk studies significantly decreased postinitiative (preinitiative: median 4 days, mean rank of low-risk studies 18.73, vs postinitiative: median 1 day, mean rank of low-risk studies 11.76, <i>P</i>=.02; and preinitiative: median 1 day, mean rank of high-risk studies 117.36, vs postinitiative: median 1 day, mean rank of high-risk studies 97.27, <i>P</i>=.01). In particular, onset to reporting was reduced more in the low-risk trial than in the high-risk trial (low-risk: median 4-0 days, vs high-risk: median 1-1 day). CONCLUSIONS We demonstrated that a real-time automatic alert system can effectively improve safety reporting timelines. The improvements were prominent in phase 1 and in low- and high-risk clinical trials. These findings suggest that an information technology-driven automatic alert system effectively improves safety reporting timelines, which may enhance patient safety.

The pop-parent software system: A distributed data processing and clinical trial management system for the NHLBI BARI

1989 ◽  
Vol 10 (3) ◽  
pp. 339 ◽  
Author(s):  
William P. Amoroso ◽  
Donald Borrebach ◽  
Timothy E. Kuntz ◽  
Lawrence A. Kamons ◽  
Jeffrey Martin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Data Processing ◽  
Management System ◽  
Distributed Data ◽  
Software System ◽  
Trial Management ◽  
Distributed Data Processing ◽  
System A ◽  
Clinical Trial Management
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