Evidence map›Paper›PMID 31843583›Full record

ArticleThe journal of pain

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

Jennifer S Gewandter, Robert H Dworkin, Dennis C Turk, Eric G Devine, David Hewitt, Mark P Jensen, Nathaniel P Katz, Amy A Kirkwood, Richard Malamut, John D Markman and 29 more

Open access · greenAbstract readConsensus Statement
In one paragraph

Article in The journal of pain. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed
8.2field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 55 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

39 authors at 20 institutions in 4 countries.

Jennifer S GewandterUniversity of Rochester Medical Center, Rochester, New York. Electronic address: Jennifer_gewandter@urmc.rochester.edu.
Robert H DworkinUniversity of Rochester Medical Center, Rochester, New York.
Dennis C TurkUniversity of Washington, Seattle, Washington.
Eric G DevineBoston University, Boston, Massachusetts.
David HewittSyneos Health, Blue Bell, Pennsylvania.
Mark P JensenUniversity of Washington, Seattle, Washington.
Nathaniel P KatzAnalgesic Solutions, Natick, Massachusetts; Tufts University, Boston, Massachusetts.
Amy A KirkwoodCR UK and UCL Cancer Trials Centre, UCL Cancer Institute, London, UK.
Richard MalamutCollegium, Pharmaceutical, Stoughton, Massachusetts.
John D MarkmanUniversity of Rochester Medical Center, Rochester, New York.
Bernard VrijensAARDEX Group & Liège University, Belgium.
Laurie BurkeThe Lora Group, LLC, Maryland.
James N CampbellCentrexion Corporation, Boston, Massachusetts.
Daniel B CarrTufts University School of Medicine, Boston, Massachusetts.
Philip G ConaghanLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, & NIHR Leeds Biomedical Research Centre, Leeds, UK.
Penney CowanAmerican Chronic Pain Association, Rocklin, California.
Mittie K DoyleCSL Behring, King of Prussia, Pennsylvania.
Robert R EdwardsBrigham & Women's Hospital, Boston, Massachusetts.
Scott R EvansGeorge Washington University, Washington, District of Columbia.
John T FarrarUniversity of Pennsylvania, Philadelphia, Pennsylvania.
Roy FreemanBrigham & Women's Hospital, Boston, Massachusetts.
Ian GilronQueen's University, Kingston, Ontario, Canada.
Dean JugeHorizon Pharma, Lake Forest, Illinois.
Robert D KernsYale University, New Haven, Connecticut.
Ernest A KopeckyCollegium, Pharmaceutical, Stoughton, Massachusetts.
Michael P McDermottUniversity of Rochester Medical Center, Rochester, New York.
Gwendolyn NieblerEgalet Corporation, Wayne, Pennsylvania.
Kushang V PatelUniversity of Washington, Seattle, Washington.
Richard RauckWake Forest University School of Medicine, Winston-Salem, North Carolina.
Andrew S C RiceImperial College, London, UK.
Michael RowbothamCPMC Research Institute (Sutter Health), San Francisco, California.
Nelson E SesslerPurdue Pharma, Stamford, Connecticut.
Lee S SimonSDG, LLC, Cambridge, Massachusetts.
Neil SinglaLotus Clinical Research, Pasadena, California.
Vladimir SkljarevskiEli Lilly, Indianapolis, Indiana.
Tina TockarshewskyCeres Consulting, West Point, New York.
Geertrui F VanhoveJazz Pharmaceuticals, Palo Alto, California.
Ajay D WasanUniversity of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
James WitterNational Institutes of Health, Bethesda, Maryland.
University of Rochester Medical Center · USUniversity of Washington · USBrigham and Women's Hospital · USCollegium Pharmaceutical (United States) · USTufts University · USAmerican Chronic Pain AssociationCentrexion Therapeutics (United States) · USCeres · USCRUK Lung Cancer Centre of Excellence · GBCSL (United States) · USEli Lilly (United States) · USGeorge Washington University · USHorizon Therapeutics (United States) · USImperial College London · GBJazz Pharmaceuticals (United States) · USLotus Clinical Research · USNational Institutes of Health · USPurdue Pharma (United States) · USQueen's University · CASutter Health · US

Funding

Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) Public-Private PartnershipU01FD005936 · FDA · UNIVERSITY OF ROCHESTER · PI DWORKIN, ROBERT H · 2016 to 2020
$2.5M
FDA HHS U01 FD005936
6 · The paper itself

Abstract

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.

Indexed as

Chronic PainClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicData AccuracyPain MeasurementHumansPatient Selectionand Pain Assessment in Clinical Trialsclinical trial conductData qualityInitiative on MethodsMeasurement

Identifiers

PMID31843583
PMCPMC7292738
OpenAlexW2995524930

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.