Free Live Online Masterclass RWE & Trials with Professor Stuart Pocock
“External Controls for Trials: Strategy, Science, Regulators & HTAs”
DATE: Tuesday, 11 June 2024, at 5pm CEST | 4pm UK time | 11am EST.
Free Live Online Masterclass to learn about perspectives on external controls from an epidemiologist/clinician and eminent medical statistician, illustrated with case studies.
Attendees will learn how external controls from RWD may accelerate new treatments for single-arm clinical trials in difficult-to-enrol populations and supplement controls in randomized controlled trials (RCTs), and have their questions answered.
Learning objectives:
Understand the challenges and expectations of regulators and HTA bodies for RW external controls:
- How to develop a strategy to obtain fit-for-purpose RW natural history data and external controls.
- Appreciate how to design and analyse RW external controls and one-arm trials.
- Learn from case studies of successes and failures.
SPEAKER: Nawab Qizilbash MD MSc DPhil, Senior Clinical Epidemiologist, OXON Epidemiology.
Honorary Associate Professor in Pharmacoepidemiology, London School of Hygiene & Tropical Medicine and Clinical Observer, Internal Medicine, Madrid Hospitals.
DISCUSSANT: Stuart Pocock MSc PhD, Professor of Medical Statistics, London School of Hygiene & Tropical Medicine.
Author of +600 papers (100+NEJM/Lancets), mainly of clinical trials, epidemiology and related methodology; extensive experience of EMA/FDA and Trial Executive and Data Monitoring Committees.
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