TY - JOUR
T1 - Ensuring transparency and minimization of methodologic bias in preclinical pain research
T2 - PPRECISE considerations
AU - Andrews, Nick A.
AU - Latrémolière, Alban
AU - Basbaum, Allan I.
AU - Mogil, Jeffrey S.
AU - Porreca, Frank
AU - Rice, Andrew S.C.
AU - Woolf, Clifford J.
AU - Currie, Gillian L.
AU - Dworkin, Robert H.
AU - Eisenach, James C.
AU - Evans, Scott
AU - Gewandter, Jennifer S.
AU - Gover, Tony D.
AU - Handwerker, Hermann
AU - Huang, Wenlong
AU - Iyengar, Smriti
AU - Jensen, Mark P.
AU - Kennedy, Jeffrey D.
AU - Lee, Nancy
AU - Levine, Jon
AU - Lidster, Katie
AU - MacHin, Ian
AU - McDermott, Michael P.
AU - McMahon, Stephen B.
AU - Price, Theodore J.
AU - Ross, Sarah E.
AU - Scherrer, Grégory
AU - Seal, Rebecca P.
AU - Sena, Emily S.
AU - Silva, Elizabeth
AU - Stone, Laura
AU - Svensson, Camilla I.
AU - Turk, Dennis C.
AU - Whiteside, Garth
N1 - Publisher Copyright:
© 2016 International Association for the Study of Pain.
PY - 2016/4/1
Y1 - 2016/4/1
N2 - 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.
AB - 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.
KW - Bias
KW - Consensus
KW - Internal validity
KW - Transparent reporting
UR - http://www.scopus.com/inward/record.url?scp=84973308367&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84973308367&partnerID=8YFLogxK
U2 - 10.1097/j.pain.0000000000000458
DO - 10.1097/j.pain.0000000000000458
M3 - Article
C2 - 26683237
AN - SCOPUS:84973308367
SN - 0304-3959
VL - 157
SP - 901
EP - 909
JO - Pain
JF - Pain
IS - 4
ER -