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.
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.