Dataset Information

Assay sensitivity and study features in neuropathic pain trials: an ACTTION meta-analysis.

ABSTRACT:

Objective

Our objective was to identify patient, study, and site factors associated with assay sensitivity in placebo-controlled neuropathic pain trials.

Methods

We examined the associations between study characteristics and standardized effect size (SES) in a database of 200 publicly available randomized clinical trials of pharmacologic treatments for neuropathic pain.

Results

There was considerable heterogeneity in the SESs among the examined trials. Univariate meta-regression analyses indicated that larger SESs were significantly associated with trials that had 1) greater minimum baseline pain inclusion criteria, 2) greater mean subject age, 3) a larger percentage of Caucasian subjects, and 4) a smaller total number of subjects. In a multiple meta-regression analysis, the associations between SES and minimum baseline pain inclusion criterion and age remained significant.

Conclusions

Our analyses have examined potentially modifiable correlates of study SES and shown that a minimum pain inclusion criterion of 40 or above on a 0 to 100 scale is associated with a larger SES. These data provide a foundation for investigating strategies to improve assay sensitivity and thereby decrease the likelihood of falsely negative outcomes in clinical trials of efficacious treatments for neuropathic pain.

SUBMITTER: Dworkin RH

PROVIDER: S-EPMC3770199 | biostudies-literature | 2013 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Assay sensitivity and study features in neuropathic pain trials: an ACTTION meta-analysis.

Dworkin Robert H RH Turk Dennis C DC Peirce-Sandner Sarah S He Hua H McDermott Michael P MP Farrar John T JT Katz Nathaniel P NP Lin Allison H AH Rappaport Bob A BA Rowbotham Michael C MC

Neurology 20130522 1

<h4>Objective</h4>Our objective was to identify patient, study, and site factors associated with assay sensitivity in placebo-controlled neuropathic pain trials.<h4>Methods</h4>We examined the associations between study characteristics and standardized effect size (SES) in a database of 200 publicly available randomized clinical trials of pharmacologic treatments for neuropathic pain.<h4>Results</h4>There was considerable heterogeneity in the SESs among the examined trials. Univariate meta-regre ...[more]

PMID: 23700332

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Dataset Information

Assay sensitivity and study features in neuropathic pain trials: an ACTTION meta-analysis.

Objective

Methods

Results

Conclusions

Publications

Assay sensitivity and study features in neuropathic pain trials: an ACTTION meta-analysis.

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