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Project Rebuild the Evidence Base (REB): a method to interpret randomised clinical trials and their meta-analysis to present solid benefit-risk assessments to patients.
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  • Rémy Boussageon,
  • Clara Blanchard,
  • Elodie Charuel,
  • Thibault Menini,
  • Bruno Pereira,
  • florian naudet,
  • Behrouz Kassai,
  • François Gueyffier,
  • Michel Cucherat,
  • Hélène Vaillant-Roussel
Rémy Boussageon
Université Claude Bernard Lyon 1
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Clara Blanchard
University of Poitiers

Corresponding Author:[email protected]

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Elodie Charuel
Clermont Auvergne University
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Thibault Menini
Clermont Auvergne University
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Bruno Pereira
University Hospital Centre Clermont-Ferrand
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florian naudet
University Hospital Centre Clermont-Ferrand
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Behrouz Kassai
Universite Claude Bernard Lyon 1
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François Gueyffier
Centre Hospitalier Universitaire de Lyon
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Michel Cucherat
University Hospital Centre Clermont-Ferrand
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Hélène Vaillant-Roussel
Clermont Auvergne University
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Abstract

Introduction: Evidence-based medicine is the cornerstone of shared-decision making in healthcare today. The public deserves clear, transparent and trust-worthy information on drug efficacy. Yet today, many drugs are prescribed and used without solid evidence of efficacy. Moreover, meta-analyses are the staple to test for drug efficacy and adverse effects, but spins can lead to unconvincing conclusions. In a shared medical decision-making approach, general practitioners need drug assessment to be based on patient-important outcomes. The aim of project Rebuild the Evidence Base (REB) is to bridge the gap between the data needed in clinical practice and the data available from clinical research. Methods and Analysis: The drugs will be assessed on clinical patient important outcomes and for a population. Using the Cochrane tools, we propose to analyse for each population and outcome : 1) a meta-analysis, based on randomised controlled trials (RCTs) with low risk of bias overall ; 2) Confirmatory RCT with low risk of biais overall; 3) Heterogeneity between RCT, and 4) Publication bias assessment. Depending on the results of these analyses, evidence would be rated according to 4 levels: firm evidence, evidence, results to be confirmed (but no evidence) or lack of evidence. Conclusion: Project REB proposes a method for reading and interpreting randomized clinical trials and their meta-analysis to produce quality data for general practitioners to focus on benefit-risk assessment in the interest of patients. If this data does not exist, it could enable clinical research to better its aim.