Display options
Cite
Zuidgeest MGP, Goetz I, Meinecke AK, et al. The GetReal Trial Tool: Design, Assess and Discuss Clinical Drug Trials in Light of RWE Generation. J Clin Epidemiol. 2021;doi: 10.1016/j.jclinepi.2021.12.019.
Zuidgeest, M. G. P., Goetz, I., Meinecke, A. K., Boateng, D., Irving, E. A., van Thiel, G. J. M., Welsing, P. M. J., Oude-Rengerink, K., Grobbee, D. E., & Initiative, G. (2021). The GetReal Trial Tool: Design, Assess and Discuss Clinical Drug Trials in Light of RWE Generation. Journal of clinical epidemiology, . https://doi.org/10.1016/j.jclinepi.2021.12.019
Zuidgeest, Mira G P, et al. "The GetReal Trial Tool: Design, Assess and Discuss Clinical Drug Trials in Light of RWE Generation." Journal of clinical epidemiology vol. (2021). doi: https://doi.org/10.1016/j.jclinepi.2021.12.019
Zuidgeest MGP, Goetz I, Meinecke AK, Boateng D, Irving EA, van Thiel GJM, Welsing PMJ, Oude-Rengerink K, Grobbee DE, Initiative G. The GetReal Trial Tool: Design, Assess and Discuss Clinical Drug Trials in Light of RWE Generation. J Clin Epidemiol. 2021 Dec 17; doi: 10.1016/j.jclinepi.2021.12.019. Epub 2021 Dec 17. PMID: 34929319.
Copy Download .nbib Format: NLM
Share it on

J Clin Epidemiol. 2021 Dec 17; doi: 10.1016/j.jclinepi.2021.12.019. Epub 2021 Dec 17.

The GetReal Trial Tool: Design, Assess and Discuss Clinical Drug Trials in Light of RWE Generation.

Journal of clinical epidemiology

Mira G P Zuidgeest, Iris Goetz, Anna-Katharina Meinecke, Daniel Boateng, Elaine A Irving, Ghislaine J M van Thiel, Paco M J Welsing, Katrien Oude-Rengerink, Diederick E Grobbee, GetReal Initiative

Affiliations

  1. Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands. Electronic address: [email protected].
  2. Eli Lilly & Co Ltd, Bracknell, UK.
  3. Partnerships and IEG Office, Integrated Evidence Generation & Business Innovation, Medical Affairs & Pharmacovigilance, Bayer AG.
  4. Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.
  5. Clinical Development, GSK Research & Development Ltd., Stevenage, Hertfordshire, SG1 2NY, UK.
  6. Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands; Department of Rheumatology & Clinical immunology, University Medical Center Utrecht, Utrecht, the Netherlands.
  7. Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands; Julius Clinical, Zeist, the Netherlands.
  8. Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands; Eli Lilly & Co Ltd, Bracknell, UK; Partnerships and IEG Office, Integrated Evidence Generation & Business Innovation, Medical Affairs & Pharmacovigilance, Bayer AG; Clinical Development, GSK Research & Development Ltd., Stevenage, Hertfordshire, SG1 2NY, UK; Department of Rheumatology & Clinical immunology, University Medical Center Utrecht, Utrecht, the Netherlands; Julius Clinical, Zeist, the Netherlands.

PMID: 34929319 DOI: 10.1016/j.jclinepi.2021.12.019

Abstract

Methodologies incorporating Real World Elements into clinical trial design (also called pragmatic trials) offer an attractive opportunity to assess the effect of a treatment strategy in routine care and as such guide decision making in practice. Uptake of these methods is slow for several reasons, including uncertainty about acceptability of trial results, lack of experience with the methodology and operational challenges. We developed the 'Get Real Trial Tool', an easy-to-use interface, which allows users to assess the impact of design choices on generalisability to routine clinical practice, while taking into account risk of bias, precision, acceptability and operational feasibility. The tool is grounded in the scientific literature on pragmatic trials combined with knowledge of experts from academia, pharmaceutical companies, HTA bodies, patient organisations, and regulators. The aim is to help researchers optimise trial design and facilitate translation of evidence from pragmatic trials to clinical practice. In this paper we describe the development, structure and application of the GetReal Trial Tool.

Copyright © 2021. Published by Elsevier Inc.

Keywords: Clinical Trial; Epidemiology; Medical Ethics; Pragmatic Trial; Real World Evidence; Research Design

Publication Types