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) reporting summary developed for a large multi-center National Institutes of Health (NIH)-sponsored clinical trial.


OBJECTIVE
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.
Bell
Margaret C
MC
New England Research Institutes, Watertown, MA 02472, USA. mbell@neriscience.com
Robuck
Patricia R
PR
Wright
Elizabeth C
EC
Mihova
Marina S
MS
Hofmann
Charlotte
C
De Santo
Jennifer L
JL
Milstein
Susan L
SL
Richtmyer
Pamela A
PA
Shelton
Janel L
JL
Cormier
Maureen
M
King
Debra L
DL
Park
Choon J
CJ
Molchen
Wallis A
WA
Park
Yoon
Y
Kelley
Michelle
M
D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D000998:Antiviral Agents / Q000009:adverse effects* / Q000627:therapeutic use; D006528:Carcinoma, Hepatocellular / Q000209:etiology / Q000517:prevention & control; D003628:Database Management Systems; D018450:Disease Progression; D001330:Electronic Data Processing / Q000379:methods*; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects* / Q000627:therapeutic use; D008103:Liver Cirrhosis / Q000209:etiology / Q000517:prevention & control; D017093:Liver Failure / Q000209:etiology / Q000517:prevention & control; D008113:Liver Neoplasms / Q000209:etiology / Q000517:prevention & control; D015337:Multicenter Studies as Topic / Q000379:methods; D009316:National Institutes of Health (U.S.); D011092:Polyethylene Glycols / Q000009:adverse effects* / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D011994:Recombinant Proteins; D012107:Research Design; D014481:United States
D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C100416:peginterferon alfa-2a