Automated summaries of serious adverse events in the hepatitis C antiviral long-term treatment against cirrhosis trial

Background Even though adverse event (AE) collection and official accounting are mandatory for clinical trials, there are limited detailed guidelines specifying how to summarize the event for reporting in a timely and expeditious manner. This article details the AE and serious adverse event (SAE) re...

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Bibliographic Details
Published in:Clinical trials (London, England) England), 2009-12, Vol.6 (6), p.618-627
Main Authors: Bell, Margaret C, Robuck, Patricia R, Wright, Elizabeth C, Mihova, Marina S, Hofmann, Charlotte, De Santo, Jennifer L, Milstein, Susan L, Richtmyer, Pamela A, Shelton, Janel L, Cormier, Maureen, King, Debra L, Park, Choon J, Molchen, Wallis A, Park, Yoon, Kelley, Michelle
Format: Article
Language:English
Subjects:
Adverse Drug Reaction Reporting Systems - organization & administration
Antiviral Agents - adverse effects
Antiviral Agents - therapeutic use
Carcinoma, Hepatocellular - etiology
Carcinoma, Hepatocellular - prevention & control
Clinical trials
Database Management Systems
Disease Progression
Electronic Data Processing - methods
Hepatitis
Hepatitis C, Chronic - complications
Hepatitis C, Chronic - drug therapy
Hepatitis C, Chronic - mortality
Humans
Interferon alpha-2
Interferon-alpha - adverse effects
Interferon-alpha - therapeutic use
Liver cirrhosis
Liver Cirrhosis - etiology
Liver Cirrhosis - prevention & control
Liver Failure - etiology
Liver Failure - prevention & control
Liver Neoplasms - etiology
Liver Neoplasms - prevention & control
Multicenter Studies as Topic - methods
National Institutes of Health (U.S.)
Polyethylene Glycols - adverse effects
Polyethylene Glycols - therapeutic use
Randomized Controlled Trials as Topic - methods
Recombinant Proteins
Research Design
Research methodology
Side effects
United States
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Summary:Background Even though adverse event (AE) collection and official accounting are mandatory for clinical trials, there are limited detailed guidelines specifying how to summarize the event for reporting in a timely and expeditious manner. This article details the AE and serious adverse event (SAE) reporting summary developed for a large multi-center National Institutes of Health (NIH)-sponsored clinical trial. Purpose To review and analyze the large volume of AE data reported by 10 sites (806 SAEs and 19,034 AEs from August 2000 to May 2007) the automated SAE summary was developed. It was designed to ensure timeliness and clarity in the complex process of AE review and reporting. Methods The AE and SAE case report forms (CRFs) as well as the automated SAE summary were developed within a database management system developed by the Data Coordinating Center (DCC) which allowed for web-based data entry at the DCC and 10 sites and offered immediate overall and site-specific reports accessible by the DCC, site, and NIH project staff. Results The automated SAE summary pulled data from multiple CRFs to create a succinct and informative summary and allowed for prompt and easy reporting to the regulatory agencies. The summary was adaptable to the needs of reviewers because of the availability of multiple search options.
ISSN:1740-7745
1740-7753
1740-7753
DOI:10.1177/1740774509348525