Rebuild the Evidence Base (REB) project: a method of interpreting randomised clinical trials and their meta-analysis to present patients with robust benefit-risk assessments

Introduction. Evidence-based medicine (EBM) is the cornerstone of shared medical decision-making. The public deserves clear, transparent and trustworthy information on the effectiveness of medicines. Yet today, many drugs are prescribed and used without solid evidence of their effectiveness. Randomised clinical trials (RCTs) and their meta-analyses are the best studies to assess the effectiveness of medicines and their adverse effects, but their results are not easily interpreted in practice and are sometimes even questionable in relation to the data used. In a shared medical decision-making approach, GPs need drug evaluation to be based on outcomes that are important and relevant to the patient. The aim of the Rebuild the Evidence Base (REB) project is to bridge the gap between the evidence needed for clinical practice and the evidence available in clinical research. Methods and analysis. Drugs will be evaluated according to clinically important criteria for patients and in a particular population. Using the Cochrane tools, for each population and endpoint selected, the following will be performed: 1) meta-analysis, based on randomised controlled trials (RCTs) with an overall low risk of bias; 2) assessment of results from confirmatory RCTs; 3) assessment of statistical heterogeneity (I2), and 4) assessment of the risk of publication bias. Based on the results of these analyses, the evidence will be assessed according to 4 levels: strong evidence, convincing result but to be confirmed, signal to be confirmed, or no evidence. Conclusion. The REB project proposes a method for reading and interpreting randomised clinical trials and their meta-analysis in order to produce quality data that will allow GPs to focus on the assessment of benefit/risk in the interest of patients. If such data do not exist, it will allow clinical research to better define its objectives.