Bringing adaptive designs into practice: case studies of collaborations between statistical methodologists and CTUs 

Monday 27th November at the MRC Biostatistics Unit, East Forvie Building, Forvie Site, Robinson Way, Cambridge CB2 0SR

Registration: Adaptive Designs in Real Trials: A Dissemination Workshop, November 2023 | University of Cambridge

During this half-day hybrid event, a series of recent case studies of implementing adaptive designs in real trials will be co-presented by statistical methodologists and Clinical Trial Unit (CTU) statisticians from all around the UK. These case studies originate from Dr Pavel Mozgunov’s NIHR Advanced Fellowship focusing on bringing innovative statistical methods to practice. 

 The talks will cover all stages of the implementation: 

• planning/designing the study 
• applying for funding to conduct an adaptive trial 
• communicating the design to health authorities  
• writing protocol/SAP/SOPs 
• day-to-day conduct of the trial 

The case studies will cover various adaptive methods (e.g. dose-escalation, sample size re-estimation, multi-arm multi-stage (MAMS), Bayesian designs, etc.) in various disease areas, applied to different funding bodies, and from early to late phases. 

The event is a part of Dr Pavel Mozgunov’s NIHR Advanced Fellowship. 

This event will by a hybrid event.  When registering, please select the relevant ticket option.

Members of the CTU are eligible for free attendance (funded by the NIHR) – please contact Dr Pavel Mozgunov (pavel.mozgunov@mrc-bsu.cam.ac.uk) before registering using the link above. 

To register, please click here: Adaptive Designs in Real Trials: A Dissemination Workshop, November 2023 | University of Cambridge

Programme

12:00 – 13:00	Lunch & Networking
13:00 – 13:40	Designing and conducting a COVID-19 early-phase dose-escalation trial	Sean Ewings (Southampton CTU), Pavel Mozgunov (MRC Biostatistics Unit)
13:40 – 14:10	Designing a group sequential trial with sample size estimation for the trial of diabetic foot ulcers treatment	Apostolos Fakis (Derby CTU), Peter Greenstreet (Lancaster University, Exeter University)
14:10 – 14:40	Determining the minimum duration of treatment in tuberculosis: An order restricted non‐inferiority trial design	Alessandra Serra (MRC Biostatistics Unit)
14:40 – 15:10	Refreshments Break
15:10 – 15:40	Preparing a grant application for an early-phase dose-escalation trial in oncology	Sean Ewings (Southampton CTU), Pavel Mozgunov (MRC Biostatistics Unit)
15:40 – 16:20	How to choose parameters of your Bayesian early stopping rules: the case of multi-arm non-inferiority trial with time-to-event endpoint in COPD	Simon Bond (Cambridge CTU), Dominique Couturier (MRC Biostatistics Unit)
16:20 – 17:00	Conducting a multi-arm multi-stage trial in HIV-positive Individuals: TAILoR Phase IIb Trial	Thomas Jaki (MRC Biostatistics Unit and University of Regensburg)