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      Discovery and validation of biomarkers to aid the development of safe and effective pain therapeutics: challenges and opportunities

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          Abstract

          Pain medication plays an important role in the treatment of acute and chronic pain conditions, but some drugs, opioids in particular, have been overprescribed or prescribed without adequate safeguards, leading to an alarming rise in medication-related overdose deaths. The NIH Helping to End Addiction Long-term (HEAL) Initiative is a trans-agency effort to provide scientific solutions to stem the opioid crisis. One component of the initiative is to support biomarker discovery and rigorous validation in collaboration with industry leaders to accelerate high-quality clinical research into neurotherapeutics and pain. The use of objective biomarkers and clinical trial end points throughout the drug discovery and development process is crucial to help define pathophysiological subsets of pain, evaluate target engagement of new drugs and predict the analgesic efficacy of new drugs. In 2018, the NIH-led Discovery and Validation of Biomarkers to Develop Non-Addictive Therapeutics for Pain workshop convened scientific leaders from academia, industry, government and patient advocacy groups to discuss progress, challenges, gaps and ideas to facilitate the development of biomarkers and end points for pain. The outcomes of this workshop are outlined in this Consensus Statement.

          Abstract

          In 2018, the Discovery and Validation of Biomarkers to Develop Non-Addictive Therapeutics for Pain workshop convened to discuss strategies to facilitate the development of biomarkers and end points for pain. The outcomes of this workshop are outlined in this Consensus Statement.

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          Most cited references 235

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          Biomarkers and surrogate endpoints: preferred definitions and conceptual framework.

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            Core outcome measures for chronic pain clinical trials: IMMPACT recommendations.

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              Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017

              Summary Background The Global Burden of Diseases, Injuries, and Risk Factors Study 2017 (GBD 2017) includes a comprehensive assessment of incidence, prevalence, and years lived with disability (YLDs) for 354 causes in 195 countries and territories from 1990 to 2017. Previous GBD studies have shown how the decline of mortality rates from 1990 to 2016 has led to an increase in life expectancy, an ageing global population, and an expansion of the non-fatal burden of disease and injury. These studies have also shown how a substantial portion of the world's population experiences non-fatal health loss with considerable heterogeneity among different causes, locations, ages, and sexes. Ongoing objectives of the GBD study include increasing the level of estimation detail, improving analytical strategies, and increasing the amount of high-quality data. Methods We estimated incidence and prevalence for 354 diseases and injuries and 3484 sequelae. We used an updated and extensive body of literature studies, survey data, surveillance data, inpatient admission records, outpatient visit records, and health insurance claims, and additionally used results from cause of death models to inform estimates using a total of 68 781 data sources. Newly available clinical data from India, Iran, Japan, Jordan, Nepal, China, Brazil, Norway, and Italy were incorporated, as well as updated claims data from the USA and new claims data from Taiwan (province of China) and Singapore. We used DisMod-MR 2.1, a Bayesian meta-regression tool, as the main method of estimation, ensuring consistency between rates of incidence, prevalence, remission, and cause of death for each condition. YLDs were estimated as the product of a prevalence estimate and a disability weight for health states of each mutually exclusive sequela, adjusted for comorbidity. We updated the Socio-demographic Index (SDI), a summary development indicator of income per capita, years of schooling, and total fertility rate. Additionally, we calculated differences between male and female YLDs to identify divergent trends across sexes. GBD 2017 complies with the Guidelines for Accurate and Transparent Health Estimates Reporting. Findings Globally, for females, the causes with the greatest age-standardised prevalence were oral disorders, headache disorders, and haemoglobinopathies and haemolytic anaemias in both 1990 and 2017. For males, the causes with the greatest age-standardised prevalence were oral disorders, headache disorders, and tuberculosis including latent tuberculosis infection in both 1990 and 2017. In terms of YLDs, low back pain, headache disorders, and dietary iron deficiency were the leading Level 3 causes of YLD counts in 1990, whereas low back pain, headache disorders, and depressive disorders were the leading causes in 2017 for both sexes combined. All-cause age-standardised YLD rates decreased by 3·9% (95% uncertainty interval [UI] 3·1–4·6) from 1990 to 2017; however, the all-age YLD rate increased by 7·2% (6·0–8·4) while the total sum of global YLDs increased from 562 million (421–723) to 853 million (642–1100). The increases for males and females were similar, with increases in all-age YLD rates of 7·9% (6·6–9·2) for males and 6·5% (5·4–7·7) for females. We found significant differences between males and females in terms of age-standardised prevalence estimates for multiple causes. The causes with the greatest relative differences between sexes in 2017 included substance use disorders (3018 cases [95% UI 2782–3252] per 100 000 in males vs s1400 [1279–1524] per 100 000 in females), transport injuries (3322 [3082–3583] vs 2336 [2154–2535]), and self-harm and interpersonal violence (3265 [2943–3630] vs 5643 [5057–6302]). Interpretation Global all-cause age-standardised YLD rates have improved only slightly over a period spanning nearly three decades. However, the magnitude of the non-fatal disease burden has expanded globally, with increasing numbers of people who have a wide spectrum of conditions. A subset of conditions has remained globally pervasive since 1990, whereas other conditions have displayed more dynamic trends, with different ages, sexes, and geographies across the globe experiencing varying burdens and trends of health loss. This study emphasises how global improvements in premature mortality for select conditions have led to older populations with complex and potentially expensive diseases, yet also highlights global achievements in certain domains of disease and injury. Funding Bill & Melinda Gates Foundation.
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                Author and article information

                Contributors
                karen.davis@uhnresearch.ca
                Journal
                Nat Rev Neurol
                Nat Rev Neurol
                Nature Reviews. Neurology
                Nature Publishing Group UK (London )
                1759-4758
                1759-4766
                15 June 2020
                15 June 2020
                2020
                : 16
                : 7
                : 381-400
                Affiliations
                [1 ]ISNI 0000 0001 2157 2938, GRID grid.17063.33, Department of Surgery and Institute of Medical Science, , University of Toronto, ; Toronto, ON Canada
                [2 ]ISNI 0000 0004 0474 0428, GRID grid.231844.8, Division of Brain, Imaging and Behaviour, Krembil Brain Institute, Toronto Western Hospital, , University Health Network, ; Toronto, ON Canada
                [3 ]ISNI 0000000419368956, GRID grid.168010.e, Department of Anesthesiology, Perioperative and Pain Medicine, , Stanford University School of Medicine, ; Stanford, CA USA
                [4 ]ISNI 0000 0004 0483 9882, GRID grid.418488.9, Teva Pharmaceuticals, ; Frazer, PA USA
                [5 ]ISNI 000000041936754X, GRID grid.38142.3c, Center for Pain and the Brain, , Harvard Medical School, ; Boston, MA USA
                [6 ]Mycroft Bioanalytics, Salt Lake City, UT USA
                [7 ]Teva Pharmaceutical Industries, Frazer, PA USA
                [8 ]Xyzagen, Pittsboro, NC USA
                [9 ]ISNI 0000 0004 0378 8294, GRID grid.62560.37, Pain Management Center, , Brigham and Women’s Hospital and Harvard Medical School, ; Boston, MA USA
                [10 ]ISNI 0000 0000 9206 2401, GRID grid.267308.8, The Vivian L. Smith Department of Neurosurgery, , The University of Texas Health Science Center at Houston, McGovern Medical School, ; Houston, TX USA
                [11 ]ISNI 0000 0004 3497 6087, GRID grid.429651.d, Department of Perioperative Medicine, , Clinical Center, NIH, ; Rockville, MD USA
                [12 ]ISNI 0000 0004 3497 6087, GRID grid.429651.d, Division of Translational Research, , National Institute of Neurological Disorders and Stroke, NIH, ; Rockville, MD USA
                [13 ]ISNI 0000 0004 1936 9510, GRID grid.253615.6, The Biostatistics Center, Milken Institute School of Public Health, , The George Washington University, ; Washington, DC USA
                [14 ]ISNI 0000 0004 1936 9094, GRID grid.40263.33, Department of Neuroscience and Department of Neurosurgery, Carney Institute for Brain Science, , Brown University, ; Providence, RI USA
                [15 ]ISNI 0000 0004 0378 8294, GRID grid.62560.37, Department of Anesthesiology, , Brigham and Women’s Hospital and Harvard Medical School, ; Boston, MA USA
                [16 ]ISNI 0000 0004 0384 8146, GRID grid.417832.b, Neurocognitive Disorders, , Pain and New Indications, Biogen, ; Cambridge, MA USA
                [17 ]Asarina Pharma, Copenhagen, Denmark
                [18 ]ISNI 0000 0004 1936 8948, GRID grid.4991.5, Nuffield Department of Clinical Neurosciences, , University of Oxford, ; Oxford, UK
                [19 ]Chronic Pain Research Alliance, Bethesda, MD USA
                [20 ]ISNI 0000 0004 1936 8753, GRID grid.137628.9, Department of Anesthesiology, Perioperative Care and Pain Medicine, , NYU School of Medicine, ; New York, NY USA
                [21 ]ISNI 0000 0001 2179 2404, GRID grid.254880.3, Department of Psychological and Brain Sciences, , Dartmouth College, ; Hanover, NH USA
                [22 ]ISNI 0000 0004 1936 9000, GRID grid.21925.3d, Anesthesiology and Perioperative Medicine and Psychiatry, , University of Pittsburgh, ; Pittsburgh, PA USA
                Article
                362
                10.1038/s41582-020-0362-2
                7326705
                32541893
                © The Authors(s) 2020

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.

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                Consensus Statement
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                © Springer Nature Limited 2020

                biomarkers, chronic pain

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