Monitoring Drug Safety in Clinical Trials

Detecting Adverse Reactions in Trials (DART)

Phase I: Assessing current best analysis practice of AEs in clinical trials

Team: Rachel Phillips, Lorna Hazel, Odile Sauzet, Victoria Cornelius

A systematic review of phase II/III pharmacology trials reported in high impact journals to ascertain current best practice for collection, reporting and analysis of adverse events in randomised controlled trials.

The findings from this review are available here.

Phase II: Identifying and collating statistical methods suitable for analysis of AEs

Team: Rachel Phillips, Odile Sauzet, Victoria Cornelius

An evaluation of current statistical research methods available to analyse adverse events and detect signals of adverse drug reactions in clinical trials. 

The protocol for this project is available here.

Phase III: Statisticians survey on statistical methods for AE data analysis in RCTs

Team: Rachel Phillips, Odile Sauzet, Victoria Cornelius

An online survey of clinical trial statisticians from UKCRC CTUs and the pharmaceutical industry to measure awareness and opinions of statistical methods to analyse AEs in RCTs.  

Please contact Rachel Phillips if you would like to find out more.