The GetReal Trial Tool: design, assess and discuss clinical drug trials in light of Real World Evidence generation.
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, www.imi-getreal.eu
Author Information
Mira G P Zuidgeest: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands. Electronic address: m.g.p.zuidgeest@umcutrecht.nl.
Iris Goetz: Eli Lilly & Co Ltd, Bracknell, UK.
Anna-Katharina Meinecke: Partnerships and IEG Office, Integrated Evidence Generation & Business Innovation, Medical Affairs & Pharmacovigilance, Bayer AG, Wuppertal, Germany.
Daniel Boateng: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Elaine A Irving: Clinical Development, GSK Research & Development Ltd., Stevenage, Hertfordshire, SG1 2NY, UK.
Ghislaine J M van Thiel: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Paco M J Welsing: 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.
Katrien Oude-Rengerink: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Diederick E Grobbee: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands; Julius Clinical, Zeist, The Netherlands.
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 "GetReal Trial Tool," an easy-to-use online interface, which allows users to assess the impact of design choices on generalizability to routine clinical practice, while taking into account risk of bias, precision, acceptability and operational feasibility. The tool is grounded in the scientific literature combined with knowledge of experts from academia, pharmaceutical companies, HTA bodies, patient organizations, and regulators. The aim is to help researchers optimize 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.
