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, Bernard Vrijens, Laurie Burke, James N. Campbell, Daniel B. Carr, Philip G. Conaghan, Penney Cowan, Mittie K. Doyle, Robert R. Edwards, Scott R. Evans, John T. FarrarRoy Freeman, Ian Gilron, Dean Juge, Robert D. Kerns, Ernest A. Kopecky, Michael P. McDermott, Gwendolyn Niebler, Kushang V. Patel, Richard Rauck, Andrew S.C. Rice, Michael Rowbotham, Nelson E. Sessler, Lee S. Simon, Neil Singla, Vladimir Skljarevski, Tina Tockarshewsky, Geertrui F. Vanhove, Ajay D. Wasan, James Witter

Research output: Contribution to journalReview articlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)931-942
Number of pages12
JournalJournal of Pain
Volume21
Issue number9-10
DOIs
StatePublished - Sep 1 2020
Externally publishedYes

Keywords

  • Data quality
  • Initiative on Methods
  • Measurement
  • and Pain Assessment in Clinical Trials
  • clinical trial conduct

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology
  • Anesthesiology and Pain Medicine

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