NIHR Oxford BRC Statistics Hub Lunchtime Seminar: Trial designs for early phase trials

This is the third in a series of eight lunchtime seminars organised by the NIHR Oxford BRC Statistics Hub. Each seminar is 20 minutes long followed by 10 minutes of Q&A, and will be held via Microsoft Teams. These seminars are open to all in the University of Oxford and Oxford University Hospitals NHS Trust.

Trial designs for early phase trials

Alexander Ooms, OCTRU Senior Statistician

Wednesday 6^th November 2024, 1:00-1:30pm

Early phase clinical trials are critical for assessing the safety, dosage, and preliminary efficacy of new treatments. This seminar will outline some available designs in Phase I and Phase II settings.

Phase I trials primarily focus on determining safe dosages and identifying side effects using broad categories of ‘rule-based’ or ‘model-based’ dose escalation methods.

Phase II trials typically aim to give an early indication of treatment efficacy and further assess safety via single-arm or randomised controlled trials. Adaptive, occasionally Bayesian, designs are popular in the early phase setting and some examples of adaptive designs will be discussed.

No registration is required.

Click here to join the session.