Evaluating Quality of Adverse Event Information from Clinical Trials

Adverse event reporting in clinical trials: room for improvement.

Regulatory and ethical guidelines require clinical trial sponsors to disseminate clinical trial adverse event reports to involved investigators and human research ethics committees. Compliance with these guidelines has resulted in a major administrative burden for ethics committees. This burden does not necessarily contribute to the protection of clinical trial participants. Rationalisation of ...

Classifying Adverse Events from Clinical Trials

Evaluation of Clinical Trials

In a number of important clinical issues such as evaluation of the efficacy or effectiveness of therapeutic or preventive interventions as well as for comparing the harms of interventions, randomized controlled trials (RCTs) provide the highest levels of evidence, either directly or indirectly. It is obvious that critical appraisal of these studies to assess their validity and precision is of p...

A systematic review of immune-related adverse event reporting in clinical trials of immune checkpoint inhibitors.

BACKGROUND There are limited data about the quality of immune-related adverse event (irAE) reporting in immune checkpoint inhibitor (ICI) clinical trial publications. METHODS A systematic search of citations from Medline, EMBASE and Cochrane databases identified prospective clinical trials involving ICIs in advanced solid tumors from 2003 to 2013. A 21-point quality score (QS) was adapted fro...

Adverse event reporting in randomised trials of neuropathic pain: challenges for clinical usefulness of safety data

Background Monitoring the safety of therapies is of paramount importance in protecting patients from harm and enabling risk-benefit assessment. The recording and reporting of measures of efficacy has received considerable attention and while by no means perfect, has advanced further than the parallel assessment of harm. The stimulus for this study came from a commissioned effectiveness and cost...