Improving Study Conduct and Data Quality in Clinical Trials of Chronic Pain Treatments: IMMPACT Recommendations.

Autor:	Gewandter JS; University of Rochester Medical Center, Rochester, New York. Electronic address: Jennifer_gewandter@urmc.rochester.edu., Dworkin RH; University of Rochester Medical Center, Rochester, New York., Turk DC; University of Washington, Seattle, Washington., Devine EG; Boston University, Boston, Massachusetts., Hewitt D; Syneos Health, Blue Bell, Pennsylvania., Jensen MP; University of Washington, Seattle, Washington., Katz NP; Analgesic Solutions, Natick, Massachusetts; Tufts University, Boston, Massachusetts., Kirkwood AA; CR UK and UCL Cancer Trials Centre, UCL Cancer Institute, London, UK., Malamut R; Collegium, Pharmaceutical, Stoughton, Massachusetts., Markman JD; University of Rochester Medical Center, Rochester, New York., Vrijens B; AARDEX Group & Liège University, Belgium., Burke L; The Lora Group, LLC, Maryland., Campbell JN; Centrexion Corporation, Boston, Massachusetts., Carr DB; Tufts University School of Medicine, Boston, Massachusetts., Conaghan PG; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, & NIHR Leeds Biomedical Research Centre, Leeds, UK., Cowan P; American Chronic Pain Association, Rocklin, California., Doyle MK; CSL Behring, King of Prussia, Pennsylvania., Edwards RR; Brigham & Women's Hospital, Boston, Massachusetts., Evans SR; George Washington University, Washington, District of Columbia., Farrar JT; University of Pennsylvania, Philadelphia, Pennsylvania., Freeman R; Brigham & Women's Hospital, Boston, Massachusetts., Gilron I; Queen's University, Kingston, Ontario, Canada., Juge D; Horizon Pharma, Lake Forest, Illinois., Kerns RD; Yale University, New Haven, Connecticut., Kopecky EA; Collegium, Pharmaceutical, Stoughton, Massachusetts., McDermott MP; University of Rochester Medical Center, Rochester, New York., Niebler G; Egalet Corporation, Wayne, Pennsylvania., Patel KV; University of Washington, Seattle, Washington., Rauck R; Wake Forest University School of Medicine, Winston-Salem, North Carolina., Rice ASC; Imperial College, London, UK., Rowbotham M; CPMC Research Institute (Sutter Health), San Francisco, California., Sessler NE; Purdue Pharma, Stamford, Connecticut., Simon LS; SDG, LLC, Cambridge, Massachusetts., Singla N; Lotus Clinical Research, Pasadena, California., Skljarevski V; Eli Lilly, Indianapolis, Indiana., Tockarshewsky T; Ceres Consulting, West Point, New York., Vanhove GF; Jazz Pharmaceuticals, Palo Alto, California., Wasan AD; University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania., Witter J; National Institutes of Health, Bethesda, Maryland.
Jazyk:	angličtina
Zdroj:	The journal of pain [J Pain] 2020 Sep - Oct; Vol. 21 (9-10), pp. 931-942. Date of Electronic Publication: 2019 Dec 13.
DOI:	10.1016/j.jpain.2019.12.003
Abstrakt:	The estimated probability of progressing from phase 3 analgesic clinical trials to regulatory approval is approximately 57%, suggesting that a considerable number of treatments with phase 2 trial results deemed sufficiently successful to progress to phase 3 do not yield positive phase 3 results. Deficiencies in the quality of clinical trial conduct could account for some of this failure. An Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials meeting was convened to identify potential areas for improvement in trial conduct in order to improve assay sensitivity (ie, ability of trials to detect a true treatment effect). We present recommendations based on presentations and discussions at the meeting, literature reviews, and iterative revisions of this article. The recommendations relate to the following areas: 1) study design (ie, to promote feasibility), 2) site selection and staff training, 3) participant selection and training, 4) treatment adherence, 5) data collection, and 6) data and study monitoring. Implementation of these recommendations may improve the quality of clinical trial data and thus the validity and assay sensitivity of clinical trials. Future research regarding the effects of these strategies will help identify the most efficient use of resources for conducting high quality clinical trials. PERSPECTIVE: Every effort should be made to optimize the quality of clinical trial data. This manuscript discusses considerations to improve conduct of pain clinical trials based on research in multiple medical fields and the expert consensus of pain researchers and stakeholders from academia, regulatory agencies, and industry. (Copyright © 2020. Published by Elsevier Inc.)
Databáze:	MEDLINE
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