The GetReal Trial Tool: design, assess and discuss clinical drug trials in light of Real World Evidence generation
Zuidgeest, Mira G.P.; Goetz, Iris; Meinecke, Anna Katharina; Boateng, Daniel; Irving, Elaine A.; van Thiel, Ghislaine J.M.; Welsing, Paco M.J.; Oude-Rengerink, Katrien; Grobbee, Diederick E.
(2022) Journal of Clinical Epidemiology, volume 149, pp. 244 - 253
(Article)
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
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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.
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Keywords: Clinical trial, Epidemiology, Medical ethics, Pragmatic trial, Real world evidence, Research design, Epidemiology, Journal Article
ISSN: 0895-4356
Publisher: Elsevier USA
Note: Funding Information: Conflicts of interest: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: Dr. Zuidgeest reports grants from Innovative Medicines Initiative Joint Undertaking, during the conduct of the study; Dr. Goetz reports other from Lilly; Dr. Meinecke reports other from Bayer AG, during the conduct of the study; Dr. Boateng has nothing to disclose; Dr. Irving reports to hold shares in GlaxoSmithKline; Dr. van Thiel reports grants from Innovative Medicines Initiative Joint Undertaking, during the conduct of the study; Dr. Welsing has nothing to disclose; Dr. Oude-Rengerink reports grants from Innovative Medicines Initiative Joint Undertaking, during the conduct of the study; Dr. Grobbee reports grants from Innovative Medicines Initiative Joint Undertaking, during the conduct of the study; no other relationships or activities that could appear to have influenced the submitted work. Data sharing: No additional data available beyond what is publically available within the tool on www.getrealtrialtool.eu Funding: The work leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement no [115546] and no [807012], resources of which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/2007/2013) and EFPIA companies’ in kind contribution. The research leading to these results was conducted as part of the GetReal consortium and included literature review, group sessions and interviews with stakeholders from academia, research institutions, contract research organizations, pharmaceutical industry, regulatory authorities, health care insurers, health technology assessment (HTA) agencies, general practitioners and patient organizations. For further information please refer to http://www.imi-getreal.eu/.'' Funding Information: Funding: The work leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement no [115546] and no [807012], resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007/2013) and EFPIA companies’ in kind contribution. The research leading to these results was conducted as part of the GetReal consortium and included literature review, group sessions and interviews with stakeholders from academia, research institutions, contract research organizations, pharmaceutical industry, regulatory authorities, health care insurers, health technology assessment (HTA) agencies, general practitioners and patient organizations. For further information please refer to http://www.imi-getreal.eu/ .'' Publisher Copyright: © 2021
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