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July 02, 2013; 81 (1) Article

Assay sensitivity and study features in neuropathic pain trials

An ACTTION meta-analysis

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
First published May 22, 2013, DOI: https://doi.org/10.1212/WNL.0b013e318297ee69
Robert H. Dworkin
From the Departments of Anesthesiology (R.H.D., S.P.-S.), Biostatistics and Computational Biology (H.H., M.P.M.), and Neurology (R.H.D., M.P.M), University of Rochester School of Medicine and Dentistry, Rochester, NY; Department of Anesthesiology and Pain Medicine (D.C.T.), University of Washington, Seattle; Department of Clinical Epidemiology and Biostatistics (J.T.F.), University of Pennsylvania, Philadelphia; Analgesic Solutions, Natick, and Tufts University, Boston (N.P.K.), MA; Division of Anesthesia, Analgesia, and Addiction Products (A.H.L., B.A.R.), Food and Drug Administration, Silver Spring, MD; and California Pacific Medical Center Research Institute (M.C.R.), San Francisco, CA.
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Dennis C. Turk
From the Departments of Anesthesiology (R.H.D., S.P.-S.), Biostatistics and Computational Biology (H.H., M.P.M.), and Neurology (R.H.D., M.P.M), University of Rochester School of Medicine and Dentistry, Rochester, NY; Department of Anesthesiology and Pain Medicine (D.C.T.), University of Washington, Seattle; Department of Clinical Epidemiology and Biostatistics (J.T.F.), University of Pennsylvania, Philadelphia; Analgesic Solutions, Natick, and Tufts University, Boston (N.P.K.), MA; Division of Anesthesia, Analgesia, and Addiction Products (A.H.L., B.A.R.), Food and Drug Administration, Silver Spring, MD; and California Pacific Medical Center Research Institute (M.C.R.), San Francisco, CA.
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Sarah Peirce-Sandner
From the Departments of Anesthesiology (R.H.D., S.P.-S.), Biostatistics and Computational Biology (H.H., M.P.M.), and Neurology (R.H.D., M.P.M), University of Rochester School of Medicine and Dentistry, Rochester, NY; Department of Anesthesiology and Pain Medicine (D.C.T.), University of Washington, Seattle; Department of Clinical Epidemiology and Biostatistics (J.T.F.), University of Pennsylvania, Philadelphia; Analgesic Solutions, Natick, and Tufts University, Boston (N.P.K.), MA; Division of Anesthesia, Analgesia, and Addiction Products (A.H.L., B.A.R.), Food and Drug Administration, Silver Spring, MD; and California Pacific Medical Center Research Institute (M.C.R.), San Francisco, CA.
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Hua He
From the Departments of Anesthesiology (R.H.D., S.P.-S.), Biostatistics and Computational Biology (H.H., M.P.M.), and Neurology (R.H.D., M.P.M), University of Rochester School of Medicine and Dentistry, Rochester, NY; Department of Anesthesiology and Pain Medicine (D.C.T.), University of Washington, Seattle; Department of Clinical Epidemiology and Biostatistics (J.T.F.), University of Pennsylvania, Philadelphia; Analgesic Solutions, Natick, and Tufts University, Boston (N.P.K.), MA; Division of Anesthesia, Analgesia, and Addiction Products (A.H.L., B.A.R.), Food and Drug Administration, Silver Spring, MD; and California Pacific Medical Center Research Institute (M.C.R.), San Francisco, CA.
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Michael P. McDermott
From the Departments of Anesthesiology (R.H.D., S.P.-S.), Biostatistics and Computational Biology (H.H., M.P.M.), and Neurology (R.H.D., M.P.M), University of Rochester School of Medicine and Dentistry, Rochester, NY; Department of Anesthesiology and Pain Medicine (D.C.T.), University of Washington, Seattle; Department of Clinical Epidemiology and Biostatistics (J.T.F.), University of Pennsylvania, Philadelphia; Analgesic Solutions, Natick, and Tufts University, Boston (N.P.K.), MA; Division of Anesthesia, Analgesia, and Addiction Products (A.H.L., B.A.R.), Food and Drug Administration, Silver Spring, MD; and California Pacific Medical Center Research Institute (M.C.R.), San Francisco, CA.
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John T. Farrar
From the Departments of Anesthesiology (R.H.D., S.P.-S.), Biostatistics and Computational Biology (H.H., M.P.M.), and Neurology (R.H.D., M.P.M), University of Rochester School of Medicine and Dentistry, Rochester, NY; Department of Anesthesiology and Pain Medicine (D.C.T.), University of Washington, Seattle; Department of Clinical Epidemiology and Biostatistics (J.T.F.), University of Pennsylvania, Philadelphia; Analgesic Solutions, Natick, and Tufts University, Boston (N.P.K.), MA; Division of Anesthesia, Analgesia, and Addiction Products (A.H.L., B.A.R.), Food and Drug Administration, Silver Spring, MD; and California Pacific Medical Center Research Institute (M.C.R.), San Francisco, CA.
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Nathaniel P. Katz
From the Departments of Anesthesiology (R.H.D., S.P.-S.), Biostatistics and Computational Biology (H.H., M.P.M.), and Neurology (R.H.D., M.P.M), University of Rochester School of Medicine and Dentistry, Rochester, NY; Department of Anesthesiology and Pain Medicine (D.C.T.), University of Washington, Seattle; Department of Clinical Epidemiology and Biostatistics (J.T.F.), University of Pennsylvania, Philadelphia; Analgesic Solutions, Natick, and Tufts University, Boston (N.P.K.), MA; Division of Anesthesia, Analgesia, and Addiction Products (A.H.L., B.A.R.), Food and Drug Administration, Silver Spring, MD; and California Pacific Medical Center Research Institute (M.C.R.), San Francisco, CA.
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Allison H. Lin
From the Departments of Anesthesiology (R.H.D., S.P.-S.), Biostatistics and Computational Biology (H.H., M.P.M.), and Neurology (R.H.D., M.P.M), University of Rochester School of Medicine and Dentistry, Rochester, NY; Department of Anesthesiology and Pain Medicine (D.C.T.), University of Washington, Seattle; Department of Clinical Epidemiology and Biostatistics (J.T.F.), University of Pennsylvania, Philadelphia; Analgesic Solutions, Natick, and Tufts University, Boston (N.P.K.), MA; Division of Anesthesia, Analgesia, and Addiction Products (A.H.L., B.A.R.), Food and Drug Administration, Silver Spring, MD; and California Pacific Medical Center Research Institute (M.C.R.), San Francisco, CA.
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Bob A. Rappaport
From the Departments of Anesthesiology (R.H.D., S.P.-S.), Biostatistics and Computational Biology (H.H., M.P.M.), and Neurology (R.H.D., M.P.M), University of Rochester School of Medicine and Dentistry, Rochester, NY; Department of Anesthesiology and Pain Medicine (D.C.T.), University of Washington, Seattle; Department of Clinical Epidemiology and Biostatistics (J.T.F.), University of Pennsylvania, Philadelphia; Analgesic Solutions, Natick, and Tufts University, Boston (N.P.K.), MA; Division of Anesthesia, Analgesia, and Addiction Products (A.H.L., B.A.R.), Food and Drug Administration, Silver Spring, MD; and California Pacific Medical Center Research Institute (M.C.R.), San Francisco, CA.
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Michael C. Rowbotham
From the Departments of Anesthesiology (R.H.D., S.P.-S.), Biostatistics and Computational Biology (H.H., M.P.M.), and Neurology (R.H.D., M.P.M), University of Rochester School of Medicine and Dentistry, Rochester, NY; Department of Anesthesiology and Pain Medicine (D.C.T.), University of Washington, Seattle; Department of Clinical Epidemiology and Biostatistics (J.T.F.), University of Pennsylvania, Philadelphia; Analgesic Solutions, Natick, and Tufts University, Boston (N.P.K.), MA; Division of Anesthesia, Analgesia, and Addiction Products (A.H.L., B.A.R.), Food and Drug Administration, Silver Spring, MD; and California Pacific Medical Center Research Institute (M.C.R.), San Francisco, CA.
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Citation
Assay sensitivity and study features in neuropathic pain trials
An ACTTION meta-analysis
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
Neurology Jul 2013, 81 (1) 67-75; DOI: 10.1212/WNL.0b013e318297ee69

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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.

GLOSSARY

ACTTION=
Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks;
CI=
confidence interval;
DPN=
diabetic peripheral neuropathy;
FDA=
US Food and Drug Administration;
NRS=
numerical rating scale;
PHN=
postherpetic neuralgia;
PRISMA=
Preferred Reporting Items for Systematic Reviews and Meta-Analyses;
RCT=
randomized clinical trial;
SES=
standardized effect size;
VAS=
visual analog scale

Footnotes

  • Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.

  • Supplemental data at www.neurology.org

  • Received October 3, 2012.
  • Accepted in final form March 13, 2013.
  • © 2013 American Academy of Neurology
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