During this two-day hybrid workshop organised by the MRC Biostatistics Unit and sponsored by the NIHR - clinicians, patient representatives, and statisticians will share their perspectives and expertise on the implementation of adaptive and Bayesian clinical trials in real trials.
Description:
The first day will be primarily dedicated to talks by clinicians and patient representatives on their views and experiences of innovative clinical trial design in various therapeutic areas. These will be followed by lay talks from statisticians on the general principles of innovative designs and available guidance of their implementation.
The second day will be primarily dedicated to a series of case studies on implementation of innovative designs in practice. These will be co-presented by researchers from the MRC Biostatistics Unit, clinical trial units’ and industry statisticians. The topics will cover:
- Dose-finding trials (monotherapy, combinations, dose-schedule studies)
- Basket and platform trials
- Biomarker trials
- Bayesian Dynamic Borrowing Trials
These case studies originate from Dr Pavel Mozgunov’s NIHR Advanced Fellowship focusing on bringing innovative statistical methods to practice. The talks will focus on the high-level idea of the contribution of novel statistical methods to trial efficient and patients’ benefit and will be accessible by non-statisticians.
Audience and Participation:
The participation of clinicians and patient representatives with experience of taking part in clinical trials is particularly encouraged, especially for Day 1.
Members of the CTUs and patient groups 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 below. Certain expenses for patient representatives can also be covered – please also contact Pavel for further details.
Confirmed Speakers:
- Prof Deborah Ashby (Professor of Statistics, Imperial College London)
- Dr Sean Ewings (Head of Statistics, Southampton Clinical Trial Unit)
- Prof Amanda Farrin (Professor of Clinical Trials, Leeds Clinical Trials Research Unit)
- Prof Richard Fitzgerald (Professor of Experimental Pharmacology, University of Liverpool)
- Dr Julia Geronimi (Principal Translational Statistics Scientist, Servier)
- Dr Burak Kürsad Günhan (Senior Principal Biostatistician, Merck KGaA)
- Prof Thomas Jaki (Professor of Statistics, University of Cambridge)
- Prof Saye Khoo (Professor of Infectious Diseases, University of Liverpool)
- Andrew Kightley (Patient and Public Representative)
- Dr Alexander Murley (Lecturer in Neurology, University of Cambridge)
- Prof Xavier Paoletti (Professor of Statistics, Institute Curie)
- Dr Marie-Karelle Riviere (Statistical Methodologist Director, Saryga, France)
- Dr Louise Stanton (Principal Statistician, Southampton Clinical Trial Unit)
- Dr Stefan Symeonides (Medical Oncologist, University of Edinburgh and CRUK)
- Dr Alex Wright-Hughes (Principal Statistician, Leeds Clinical Trials Research Unit)
- Prof Christina Yap (Professor of Statistics, Institute for Cancer Research)
The event is a part of Dr Pavel Mozgunov’s NIHR Advanced Fellowship.
Programme:
Day 1 - Thursday 5th June
|
09:30 – 09:50 |
Registration and Refreshments |
|
|
09:50 – 10:00 |
Welcome |
Pavel Mozgunov, Statistician, MRC Biostatistics Unit |
|
10:00 – 10:40 |
Innovative approaches to clinical trials: A gentle introduction to adaptive and Bayesian methods |
Thomas Jaki, Statistician, MRC Biostatistics Unit |
|
10:40 – 11:20 |
How innovative trials can benefit patients with infectious diseases |
Saye Khoo, Clinician, University of Liverpool |
|
11:20 – 11:50 |
Refreshments |
|
|
11:50 – 12:30 |
Lessons learned when using new statistical models in the middle of the COVID-19 pandemic to battle the pandemic |
Richard Fitzgerald, Clinician, University of Liverpool |
|
12:30 – 13:10 |
How innovative trials can benefit patients with dementia |
Alexander Murley, Clinician, University of Cambridge |
|
13:10 – 14:10 |
Lunch |
|
|
14:10 – 14:50 |
Better Trials, Better Answers: Designing Trials That Truly Matter |
Christina Yap, Statistician, Institute for Cancer Research |
|
14:50 – 15:30 |
The Other Side of the Coin: from Priory to Plain Language |
Andrew Kightley, Public Contributor, Birmingham |
|
15:30 – 16:00 |
Refreshments |
|
|
16:00 – 16:45 |
Selecting the right dose of a new treatment: case in early phase cancer drug development |
Stefan Symeonidis, Clinician, University of Edinburgh |
Day 2 - Friday 6th June
|
09:10 – 09:30 |
Refreshments |
|
|
09:30 – 10:10 |
Necessity is the Mother of Invention: Adapting Trials in Times of Challenge |
Deborah Ashby, Imperial College London |
|
10:10 – 10:35 |
Working with clinicians, patients, and statisticians to develop a trial to test complex interventions to help stroke survivors |
Amanda Farrin and Alexandra Wright-Hughes, Leeds Clinical Trials Research Unit |
|
10:35 – 11:00 |
One Trial, Many Diseases: The Evolution of a Complex Trial Design |
Libby Daniells, MRC Biostatistics Unit |
|
11:00 – 11:30 |
Refreshments |
|
|
11:30 – 11:55 |
How we amended our trial to use data from another trial when the usual treatment given to patients changed – our experiences from Lymphoma |
Louise Stanton, Southampton Clinical Trials Unit and Alessandra Serra, MRC Biostatistics Unit |
|
11:55 – 12:20 |
Grant me the courage to change the things I can: dynamic borrowing of historical information for a trial in cancer of the appendix |
Sean Ewings, Southampton Clinical Trials Unit and Gianmarco Caruso, MRC Biostatistics Unit |
|
12:20 – 13:20 |
Lunch |
|
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13:20 – 13:45 |
How to find groups of patients benefiting the most from the new treatments: case of bigger trials |
Marie-Karelle Riviere, Saryga |
|
13:45 – 14:10 |
How to find the group of patients benefiting the most from the treatment with very little data? |
Julia Geronimi, Servier Alessandra Serra, MRC Biostatistics Unit |
|
14:10 – 14:50 |
How to find the right dose of novel cancer treatments: case of CAR-T cell therapies
|
Xavier Paoletti, Institute Curie Weishi Chen, MRC Biostatistics Unit |
|
14:50 – 15:20 |
Refreshments |
|
|
15:20 – 15:45 |
Looking at how early cancer drug trials are designed, now this has been changing recently |
Anais Andrillon, Saryga |
|
15:45 – 16:10 |
Practical considerations for cancer trials of finding the right doses of multiple drugs |
Burak Kuersad Guenhan, Merck KGaA |
|
16:10 – 16:35 |
Want to combine your new drug with another one? Think ahead! |
Pavel Mozgunov, MRC Biostatistics Unit |