title: Ensuring transparency and minimization of methodologic bias in preclinical pain research: PPRECISE considerations.
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.
authors.affiliation: Department of Neurobiology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA Department of Anatomy, University of California San Francisco, San Francisco, CA, USA Department of Psychology and Alan Edwards Centre for Research on Pain, McGill University, Montreal, Canada Department of Pharmacology, College of Medicine, University of Arizona, Tucson, AZ, USA Pain Research, Department of Surgery and Cancer, Imperial College, London, United Kingdom Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, United Kingdom Departments of Anesthesiology, Neurology, and Psychiatry, University of Rochester, Rochester, NY, USA Department of Anesthesiology, Wake Forest School of Medicine, Winston-Salem, NC, USA Department of Biostatistics, Harvard University, Boston, MA, USA Department of Anesthesiology, University of Rochester, Rochester, NY, USA Clinical and Rehabilitative Medicine Research Program, United States Army Medical Research and Materiel Command, Fort Detrick, MD, USA Department of Physiology and Pathophysiology, Friedrich-Alexander Universität, Erlangen-Nürnberg, Germany Institute of Medical Sciences, University of Aberdeen, Aberdeen, United Kingdom Eli Lilly & Co., Indianapolis, IN, USA Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA Neuroscience Discovery Research, Eli Lilly & Co., Indianapolis, IN, USA Policy Department, Wellcome Trust, London, United Kingdom Departments of Medicine and Oral Surgery, University of California San Francisco, San Francisco, CA, USA National Centre for Replacement, Refinement & Reduction of Animals in Research, London, United Kingdom Kent, United Kingdom Department of Biostatistics and Computational Biology and Department of Neurology, University of Rochester, Rochester, NY, USA Neurorestoration group, King's College, London, United Kingdom School of Behavioral and Brain Sciences, University of Texas at Dallas, TX, USA Department of Neurobiology, University of Pittsburgh, Pittsburgh, PA, USA Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, CA, USA Department of Neurobiology, University of Pittsburgh, Pittsburgh, PA, USA Office of Career and Professional Development, University of California San Francisco, San Francisco, CA, USA Faculty of Dentistry & Alan Edwards Centre for Research on Pain, McGill University, Montreal, Canada Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA Discovery Research, Purdue Pharma, Cranbury, NJ, USA.
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mesh_terms: D000700:Analgesics / Q000627:therapeutic use*; D015982:Bias; D019317:Evidence-Based Medicine / Q000379:methods; D006801:Humans; D010146:Pain / Q000188:drug therapy; D012107:Research Design
chemical_list: D000700:Analgesics