Speakers: Dr Pavel Mozgunov (Lancaster University)
and Dr Suzie Cro (Imperial College)
Chair: Dr Simon Bond; Senior Statistician, Cambridge Clinical Trials Unit.
Abstract: There is a growing interest in dose-finding clinical trials studying combinations of several treatments. In this talk, we will present an advanced model-based dose-finding design for an upcoming two-stage dual-agent clinical trial in opiate detoxification. The distinguishing feature of this trial is that one of the treatment compounds is given in continuous doses and is determined externally for each patient individually by a treating clinician, while another one is being dose-escalated in discrete dose levels.
We will start by providing an overview of the clinical setting and motivate the necessity of a more complex design. We will then present the novel dose-finding design and explain how its formulation was embedded in the overall objectives of the study. We will discuss how to set up the model parameters given the clinical input, and illustrate how the operating characteristics of the proposed design can be comprehensively evaluated and clearly communicated to clinicians and funders.
This event is part of the NIHR Statistics – Early Phase Trials Group webinar series on “Practical applications of advanced designs in Phase I Trials”. Registration is free and is limited to 100 attendees. Places will be offered on a first come first served basis. A recording of the webinar will be made available after the event.
For further information, please contact Professor Christina Yap, firstname.lastname@example.org (webinar organiser and co-chair of the NIHR Statistics Group – Early Phase Clinical Trials) and Ms Tara Thorneycroft, email@example.com (event co-ordinator).
Data Protection Act: Contact details will be held on a database at the ICR-CTSU (Clinical Trials and Statistics Unit) for purposes related to the webinar only.