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Completeness of Safety Reporting in Randomized Trials: An Evaluation of 7 Medical Areas

Article Abstract:

Many reports of medical research do not adequately describe the side effects of the drugs being studied or discuss the reasons why patients had to stop taking the drug. This was the conclusion of researchers who analyzed 192 drug trials covering 130,074 patients.

Author: Ioannidis, John P. A., Lau, Joseph
Publisher: American Medical Association
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 2001
Drugs, Complications and side effects, Adverse drug reactions

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Comparison of Evidence of Treatment Effects in Randomized and Nonrandomized Studies

Article Abstract:

A randomized clinical trial may produce different results than a non-randomized trial, according to researchers who used meta-analysis to compare 240 randomized trials and 168 non-randomized trials of 45 different treatments. Randomization means that patients are assigned randomly to either the treatment group or the group that receives a placebo, or inactive substance.

Author: Ioannidis, John P. A., Lau, Joseph, Haidich, Anna-Bettina, Pappa, Maroudia, Pantazis, Nikos, Kokori, Styliani I., Tektonidou, Maria G., Contopoulos-Ioannidis, Despina G.
Publisher: American Medical Association
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 2001
Methods

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Large trials vs meta-analysis of smaller trials: how do their results compare?

Article Abstract:

In most cases, the results of a large clinical trial will agree with the meta-analysis of the smaller trials on that same topic. This was demonstrated by researchers who identified 79 meta-analyses that included one large study of 1,000 or more patients and 61 meta-analyses that included one large study based on statistical power. In 82% to 90% of the cases, the large trial confirmed the results of the meta-analysis. In the 15 cases where the large trial did not confirm the meta-analysis, most of the difference could be accounted for.

Author: Ioannidis, John P.A., Lau, Joseph, Schmid, Christopher H., Chalmers, Thomas C., Cappelleri, Joseph C., De Ferranti, Sarah D., Aubert, Michael
Publisher: American Medical Association
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 1996
Meta-analysis

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Subjects list: Evaluation, Clinical trials, Medical research
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