Objectives:

Most clinical trial reports say too little about adverse events (AEs) or harms that occur during or after the trial. Few adequately describe AEs and their timing, nor how they were ascertained. Beneficial effects get much more space in reports than harms, and this seriously biases assessment of the benefit/ harm relationship. The workshop should help authors and editors to correct this imbalance.

Description:

The introduction will explain that the evidence hierarchy for harms differs from that for beneficial effects, and that essential qualitative and quantitative evidence also comes from sources other than clinical trials (Vandenbroucke 2008). The workshop will break into groups to discuss different reviews and RCTs, and assess the ways in which they deal with AEs and the likely bias in their approach. Finally the whole workshop will consider the work of the small groups, and discuss how they want to use the conclusions in future. Those present will be invited to take part in future work on how to address these problems. Vandenbroucke JP. Observational research, randomised trials and two views of medical science. PLoS Medicine 2008; 5(3):e67