Evaluation of Safety Data Reporting in Randomized Trails. Abstract, ExecutiveSummary and Final Report

摘要

The main aim of this project was to evaluate the quantity and the quality ofreporting of safety information in published reports on randomized comparative trials across several medical disciplines and to assess whether there are predictors that affect the reporting. The authors surveyed safety reporting in 192 randomized drug trials involving 130,074 patients in seven medical areas. The quality and quantity of safety reporting vary across medical areas, study designs and settings, but they are largely inadequate. The severity of clinical adverse events was adequately defined only in 39% of trial reports. Only 46% of the trials stated the frequency of specific reasons for discontinuation of study treatment due to toxicity. The median amount of space allocated to safety results was 0.3 pages. This amount was similar to the space devoted to contributor names and affiliations. Another project aim was to assess the feasibility of retrieving additional and standardized safety information on interventions tested in randomized trials directly from trialists.