@article{e771130dbd85489e80d2f38492c80cdf,
title = "Partnering with patients in clinical trials of pain treatments: A narrative review",
abstract = "The interest and the rationale for meaningful engagement of patients as partners in clinical trials of pain treatments has been increasing. No specific guidance on patient engagement for pain research studies currently exists; thus, the goal of this narrative review was to provide a historical perspective and a current evaluation of the literature on engaging patients as partners in clinical studies in general and in pain-related studies more specifically. We described how regulatory and funding agencies have developed approaches to incorporate input from patients and patient partners in their decision-making processes. We provided an overview on key practices of patient recruitment and engagement as partners in clinical research and highlighted the perceived benefits and challenges of such partnerships. We summarized factors that can facilitate or hinder meaningful patient engagement in clinical trials of pain treatments and outlined gaps that future research should address to optimize patient-centered clinical research.",
keywords = "Clinical trials of pain, Guidelines, Patient engagement, Patient partners",
author = "Holzer, {Katherine J.} and Christin Veasley and Kerns, {Robert D.} and Edwards, {Robert R.} and Gewandter, {Jennifer S.} and Langford, {Dale J.} and Yaeger, {Lauren H.} and Ewan McNicol and McKenzie Ferguson and Turk, {Dennis C.} and Dworkin, {Robert H.} and Simon Haroutounian",
note = "Funding Information: Preparation of this narrative review was supported by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the US Food and Drug Administration (FDA). ACTTION has received contracts, grants, or other revenue from the FDA, multiple pharmaceutical and device companies, royalties, philanthropy, and other sources. The views expressed in this article are those of the authors, and no official endorsement by the FDA or the pharmaceutical and device companies that provided unrestricted grants to support the activities of the ACTTION public–private partnership should be inferred. Funding Information: In the past 36 months, J. Gewandter has received grant funding from the NIH and consulting income from Abalone Bio, Algo Therapeutix, Asahi Kasei Pharma, GW Pharma, Disarm Therapeutics, Magnolia Neurosciences, Mitobridge, Orthogonal Neurosciences, Science Branding Communications, SK Life Science, and Saluda Medical. In the past 36 months, D. Turk has received research grants and contracts from the US Food and Drug Administration and US National Institutes of Health and has received compensation for consulting on clinical trials and patient preferences from AccelRx, Eli Lilly and Company, Flexion, GlaxoSmithKline, Pfizer, and Swing Therapeutics. R.H. Dworkin has received in the past 5 years research grants and contracts from the US Food and Drug Administration and the US National Institutes of Health and compensation for serving on advisory boards or consulting on clinical trial methods from Abide, Acadia, Adynxx, Analgesic Solutions, Aptinyx, Aquinox, Asahi Kasei, Astellas, AstraZeneca, Biogen, Biohaven, Boston Scientific, Braeburn, Cardialen, Celgene, Centrexion, Chromocell, Clexio, Collegium, Concert, Confo, Decibel, Dong-A, Editas, Eli Lilly, Ethismos (equity), Eupraxia, Exicure, Glenmark, Gloriana, Grace, Hope, Immune, Lotus, Mainstay, Merck, Mind Medicine (also equity), Neumentum, Neurana, NeuroBo, Novaremed, Novartis, Olatec, OliPass, Pfizer, Phosphagenics, Quark, Reckitt Benckiser, Regenacy (also equity), Relmada, Sangamo, Sanifit, Scilex, Semnur, SIMR Biotech, Sinfonia, SK Life Sciences, Sollis, SPRIM, Teva, Theranexus, Toray, Trevena, Vertex, Vizuri, and WCG. S. Haroutounian reports receiving in the past 36 months research support from the National Institutes of Health, US Department of Defense, and Disarm Therapeutics and personal fees from Medoc Ltd, Vertex Pharmaceuticals, GW Pharma, and Rafa Laboratories. The remaining authors have no conflicts interest to declare. Acknowledgements Publisher Copyright: {\textcopyright} 2022 Lippincott Williams and Wilkins. All rights reserved.",
year = "2022",
month = oct,
day = "1",
doi = "10.1097/j.pain.0000000000002600",
language = "English",
volume = "163",
pages = "1862--1873",
journal = "Pain",
issn = "0304-3959",
number = "10",
}