Assay Sensitivity and Study Features in Neuropathic Pain Trials: an ACTTION Meta-analysis

Overview

Journal Neurology

Specialty Neurology

Date 2013 May 24

PMID 23700332

Citations 19

Authors

Robert H Dworkin

Dennis C Turk

Sarah Peirce-Sandner

Hua He

Michael P McDermott

John T Farrar

Nathaniel P Katz

Allison H Lin

Bob A Rappaport

Michael C Rowbotham

Affiliations

Soon will be listed here.

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.

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