Strengthening the reporting of harms of all interventions in clinical trials

[Extract]
Harms in clinical trials may be characterised by adverse events (AEs) and adverse reactions. Both terms refer to untoward medical occurrences in a trial participant, but the second term presumes causation and is reserved for events directly attributed to the investigational treatment. Harms reporting in clinical trials is critical to understanding the nature and likelihood of experiencing unwanted effects resulting from or following treatment. Evidence to guide safe and effective use of treatments requires information on both possible benefits and harms. The CONSORT checklist for randomised controlled trials1 mandates reporting of harms, with specific guidance provided in the CONSORT extension for harms.2 However, a key problem is that information on harms is absent or reported inconsistently in clinical trials, warranting efforts to strengthen reporting of harms globally.