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Pain. 2016 Apr;157(4):901-9. doi: 10.1097/j.pain.0000000000000458.

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

Author information

1
aDepartment of Neurobiology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA bDepartment of Anatomy, University of California San Francisco, San Francisco, CA, USA cDepartment of Psychology and Alan Edwards Centre for Research on Pain, McGill University, Montreal, Canada dDepartment of Pharmacology, College of Medicine, University of Arizona, Tucson, AZ, USA ePain Research, Department of Surgery and Cancer, Imperial College, London, United Kingdom fCentre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, United Kingdom Departments of gAnesthesiology, hNeurology, and iPsychiatry, University of Rochester, Rochester, NY, USA jDepartment of Anesthesiology, Wake Forest School of Medicine, Winston-Salem, NC, USA kDepartment of Biostatistics, Harvard University, Boston, MA, USA lDepartment of Anesthesiology, University of Rochester, Rochester, NY, USA mClinical and Rehabilitative Medicine Research Program, United States Army Medical Research and Materiel Command, Fort Detrick, MD, USA nDepartment of Physiology and Pathophysiology, Friedrich-Alexander Universität, Erlangen-Nürnberg, Germany oInstitute of Medical Sciences, University of Aberdeen, Aberdeen, United Kingdom pEli Lilly & Co., Indianapolis, IN, USA qDepartment of Rehabilitation Medicine, University of Washington, Seattle, WA, USA rNeuroscience Discovery Research, Eli Lilly & Co., Indianapolis, IN, USA sPolicy Department, Wellcome Trust, London, United Kingdom Departments of tMedicine and uOral Surgery, University of California San Francisco, San Francisco, CA, USA vNational Centre for Replacement, Refinement & Reduction of Animals in Research, London, United Kingdom wKent, United Kingdom xDepartment of Biostatistics and Computational Biology and Department of Neurology, University of Rochester, Rochester, NY, USA yNeurorestoration group, King's College, London, United Kingdom zSchool of Behavioral and Brain Sciences, University of Texas at Dallas, TX, USA aaDepartment of Neuro

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 U.S. Food and Drug Administration 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 the 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 to achieve the goal of finding effective new treatments for patients with pain, the pain field needs to deal with these challenging issues.

PMID:
26683237
PMCID:
PMC4794131
DOI:
10.1097/j.pain.0000000000000458
[Indexed for MEDLINE]
Free PMC Article

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