Document Detail

A web-based clinical trial management system for a sham-controlled multicenter clinical trial in depression.
MedLine Citation:
PMID:  20083496     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Clinical trial investigators and sponsors invest vast amounts of resources and energy into conducting trials and often face daily challenges with data management, project management, and data quality control. Rather than waiting months for study progress reports, investigators need the ability to use real-time data for the coordination and management of study activities across all study team members including site investigators, oversight committees, data and safety monitoring boards, and medical safety monitors. Web-based data management systems are beginning to meet this need but what distinguishes one system from the other are user needs/requirements and cost. PURPOSE: To illustrate the development and implementation of a web-based data and project management system for a multicenter clinical trial designed to test the superiority of repeated transcranial magnetic stimulation versus sham for the treatment of patients with major depression. METHODS: The authors discuss the reasons for not using a commercially available system for this study and describe the approach to developing their own web-based system for the OPT-TMS study. Timelines, effort, system architecture, and lessons learned are shared with the hope that this information will direct clinical trial researchers and software developers towards more efficient, user-friendly systems. RESULTS: The developers use a combination of generic and custom application code to allow for the flexibility to adapt the system to the needs of the study. Features of the system include: central participant registration and randomization; secure data entry at the site; participant progress/study calendar; safety data reporting; device accounting; monitor verification; and user-configurable generic reports and built-in customized reports. LIMITATIONS: Hard coding was more time-efficient to address project-specific issues compared with the effort of creating a generic code application. As a consequence of this strategy, the required maintenance of the system is increased and the value of using this system for other trials is reduced. CONCLUSION: Web-based central computerized systems offer time-saving, secure options for managing clinical trial data. The choice of a commercially available system or an internally developed system is determined by the requirements of the study and users. Pros and cons to both approaches were discussed. If the intention is to use the system for various trials (single and multi-center, phases I-III) across various therapeutic areas, then the overall design should be a generic structure that simplifies the general application with minimal loss of functionality.
Valerie Durkalski; Wenle Zhao; Catherine Dillon; Jaemyung Kim
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Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural     Date:  2010-01-18
Journal Detail:
Title:  Clinical trials (London, England)     Volume:  7     ISSN:  1740-7753     ISO Abbreviation:  Clin Trials     Publication Date:  2010 Apr 
Date Detail:
Created Date:  2010-04-08     Completed Date:  2010-06-21     Revised Date:  2010-09-29    
Medline Journal Info:
Nlm Unique ID:  101197451     Medline TA:  Clin Trials     Country:  England    
Other Details:
Languages:  eng     Pagination:  174-82     Citation Subset:  IM    
Department of Biostatistics, Bioinformatics and Epidemiology, Medical University of South Carolina, Charleston, SC, USA.
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MeSH Terms
Depressive Disorder, Major / therapy*
Information Management / methods*
Multicenter Studies as Topic*
Randomized Controlled Trials as Topic / methods*
Transcranial Magnetic Stimulation*
Grant Support

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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