Ensuring transparency and minimization of methodologic bias in preclinical pain research: PPRECISE considerations

Nick A. Andrews, Alban Latrémolière, Allan I. Basbaum, Jeffrey S. Mogil, Frank Porreca, Andrew S. C. Rice, Clifford J. Woolf, Gillian L. Currie, Robert H. Dworkin, James C. Eisenach, Scott Evans, Jennifer S. Gewandter, Tony D. Gover, Hermann Handwerker, Wenlong Huang, Smriti Iyengar, Mark P. Jensen, Jeffrey D. Kennedy, Nancy Lee, Jon LevineKatie Lidster, Ian Machin, Michael P. McDermott, Stephen B. McMahon, Theodore J. Price, Sarah E. Ross, Grégory Scherrer, Rebecca P. Seal, Emily S. Sena, Elizabeth Silva, Laura Stone, Camilla I. Svensson, Dennis C. Turk, Garth Whiteside

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Abstract

There is growing concern about lack of scientific rigor and transparent reporting across many preclinical fields of biological research. Poor experimental design and lack of transparent reporting can result in conscious or unconscious experimental bias producing results that are not replicable. The Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the US Food and Drug Administration (FDA) sponsored a consensus meeting of the Preclinical Pain Research Consortium for Investigating Safety and Efficacy (PPRECISE) Working Group. International participants from universities, funding agencies, government agencies, industry, and a patient advocacy organization attended. Reduction of publication bias, increasing the ability of others to faithfully repeat experimental methods, and increased transparency of data reporting were specifically discussed.Parameters deemed essential to increase confidence in published literature were: clear, specific reporting of an a priori hypothesis and definition of primary outcome measure. Power calculations and whether measurement of minimal meaningful effect size to determine these should be a core component of the preclinical research effort provoked considerable discussion, with many but not all agreeing. Greater transparency of reporting should be driven by scientists, journal editors, reviewers and grant funders. The conduct of high quality science that is fully reported should not preclude novelty and innovation in preclinical pain research and indeed any efforts that curtail such innovation would be misguided. We believe that in order to achieve the goal of finding effective new treatments for patients with pain, the pain field needs to deal with these challenging issues.

Original languageEnglish
Pages (from-to)901-909
Number of pages9
JournalPain
Volume157
Issue number4
Early online date16 Dec 2015
DOIs
Publication statusPublished - Apr 2016

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Keywords

  • transparent reporting
  • consensus
  • bias
  • internal validity

Cite this

Andrews, N. A., Latrémolière, A., Basbaum, A. I., Mogil, J. S., Porreca, F., Rice, A. S. C., Woolf, C. J., Currie, G. L., Dworkin, R. H., Eisenach, J. C., Evans, S., Gewandter, J. S., Gover, T. D., Handwerker, H., Huang, W., Iyengar, S., Jensen, M. P., Kennedy, J. D., Lee, N., ... Whiteside, G. (2016). Ensuring transparency and minimization of methodologic bias in preclinical pain research: PPRECISE considerations. Pain, 157(4), 901-909. https://doi.org/10.1097/j.pain.0000000000000458