Talk Real World Evidence track
Historical Placebo Controls to Characterize Event Rates in Ongoing RCTs
Thu, Feb 6, 2025 · 8:55–9:25 AM EST Rosen Shingle Creek
About this session
The ‘Adverse Events in Placebo controls of AbbVie Clinical Trials’ (AEPACT) database developed by AbbVie leverages placebo control or standard of care arms from historical RCTs to estimate background AE rates and provide evidence in decision-making for SAE unblinding in ongoing, unblinded trials. By utilizing MedDRA SMQs, estimates of SAEs can be generated, offering a range of expected emerging AEs in these trials. This approach allows for unique insights into the background event rates of AEs in ongoing trials.
