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Ensuring transparency and minimization of methodologic bias in preclinical pain research: PPRECISE considerations
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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Wolters Kluwer
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4794131/ https://www.ncbi.nlm.nih.gov/pubmed/26683237 http://dx.doi.org/10.1097/j.pain.0000000000000458 |
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author | Andrews, Nick A. Latrémolière, Alban Basbaum, Allan I. Mogil, Jeffrey S. Porreca, Frank Rice, Andrew S.C. Woolf, Clifford J. Currie, Gillian L. Dworkin, Robert H. Eisenach, James C. Evans, Scott Gewandter, Jennifer S. Gover, Tony D. Handwerker, Hermann Huang, Wenlong Iyengar, Smriti Jensen, Mark P. Kennedy, Jeffrey D. Lee, Nancy Levine, Jon Lidster, Katie Machin, Ian McDermott, Michael P. McMahon, Stephen B. Price, Theodore J. Ross, Sarah E. Scherrer, Grégory Seal, Rebecca P. Sena, Emily S. Silva, Elizabeth Stone, Laura Svensson, Camilla I. Turk, Dennis C. Whiteside, Garth |
author_facet | Andrews, Nick A. Latrémolière, Alban Basbaum, Allan I. Mogil, Jeffrey S. Porreca, Frank Rice, Andrew S.C. Woolf, Clifford J. Currie, Gillian L. Dworkin, Robert H. Eisenach, James C. Evans, Scott Gewandter, Jennifer S. Gover, Tony D. Handwerker, Hermann Huang, Wenlong Iyengar, Smriti Jensen, Mark P. Kennedy, Jeffrey D. Lee, Nancy Levine, Jon Lidster, Katie Machin, Ian McDermott, Michael P. McMahon, Stephen B. Price, Theodore J. Ross, Sarah E. Scherrer, Grégory Seal, Rebecca P. Sena, Emily S. Silva, Elizabeth Stone, Laura Svensson, Camilla I. Turk, Dennis C. Whiteside, Garth |
author_sort | Andrews, Nick A. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-4794131 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | Wolters Kluwer |
record_format | MEDLINE/PubMed |
spelling | pubmed-47941312016-04-05 Ensuring transparency and minimization of methodologic bias in preclinical pain research: PPRECISE considerations Andrews, Nick A. Latrémolière, Alban Basbaum, Allan I. Mogil, Jeffrey S. Porreca, Frank Rice, Andrew S.C. Woolf, Clifford J. Currie, Gillian L. Dworkin, Robert H. Eisenach, James C. Evans, Scott Gewandter, Jennifer S. Gover, Tony D. Handwerker, Hermann Huang, Wenlong Iyengar, Smriti Jensen, Mark P. Kennedy, Jeffrey D. Lee, Nancy Levine, Jon Lidster, Katie Machin, Ian McDermott, Michael P. McMahon, Stephen B. Price, Theodore J. Ross, Sarah E. Scherrer, Grégory Seal, Rebecca P. Sena, Emily S. Silva, Elizabeth Stone, Laura Svensson, Camilla I. Turk, Dennis C. Whiteside, Garth Pain Research Paper 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. Wolters Kluwer 2015-12-16 2016-04 /pmc/articles/PMC4794131/ /pubmed/26683237 http://dx.doi.org/10.1097/j.pain.0000000000000458 Text en © 2016 International Association for the Study of Pain This is an open access article distributed under the terms of the Creative Commons Attribution License 4.0 (CC BY) (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Research Paper Andrews, Nick A. Latrémolière, Alban Basbaum, Allan I. Mogil, Jeffrey S. Porreca, Frank Rice, Andrew S.C. Woolf, Clifford J. Currie, Gillian L. Dworkin, Robert H. Eisenach, James C. Evans, Scott Gewandter, Jennifer S. Gover, Tony D. Handwerker, Hermann Huang, Wenlong Iyengar, Smriti Jensen, Mark P. Kennedy, Jeffrey D. Lee, Nancy Levine, Jon Lidster, Katie Machin, Ian McDermott, Michael P. McMahon, Stephen B. Price, Theodore J. Ross, Sarah E. Scherrer, Grégory Seal, Rebecca P. Sena, Emily S. Silva, Elizabeth Stone, Laura Svensson, Camilla I. Turk, Dennis C. Whiteside, Garth Ensuring transparency and minimization of methodologic bias in preclinical pain research: PPRECISE considerations |
title | Ensuring transparency and minimization of methodologic bias in preclinical pain research: PPRECISE considerations |
title_full | Ensuring transparency and minimization of methodologic bias in preclinical pain research: PPRECISE considerations |
title_fullStr | Ensuring transparency and minimization of methodologic bias in preclinical pain research: PPRECISE considerations |
title_full_unstemmed | Ensuring transparency and minimization of methodologic bias in preclinical pain research: PPRECISE considerations |
title_short | Ensuring transparency and minimization of methodologic bias in preclinical pain research: PPRECISE considerations |
title_sort | ensuring transparency and minimization of methodologic bias in preclinical pain research: pprecise considerations |
topic | Research Paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4794131/ https://www.ncbi.nlm.nih.gov/pubmed/26683237 http://dx.doi.org/10.1097/j.pain.0000000000000458 |
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