About

Course linked to
European Statistical Forum
| 14 November 2023 - Munich
"Statistical Methodology in Precision Medicine and the role of Artificial Intelligence"


Precision medicine is about going beyond assessing whether a new treatment works on average to predicting which subgroups of patients receive benefit and to what extent. Precision medicine offers substantial advantages to patients, trial sponsors, and the wider healthcare system.

However, a barrier to realising the promise of precision medicine is the inappropriate use of traditional clinical trial design and analysis, which rely on estimates of population-averaged effects.

In this course, we introduce the concept of precision medicine and cover some innovative approaches, including basket, umbrella, and platform trials, and the benefits of Bayesian approaches for the design/analysis of these trials. These trial design approaches have all been developed to improve power and patient benefit provided by clinical trials.

Examples from a wide variety of therapeutic areas will be discussed, with implementation in the OpenBUGS and R software.

Perspectives will be given on the future development of design, conduct and analysis of clinical trials in the field.

Lecture 1 – Precision medicine and the need for novel statistical approaches

  • Precision medicine
  • Traditional clinical trials and their limitations
  • Subgroup analyses

Lecture 2 – Innovative designs for clinical trials in precision medicine

  • Basket trials
  • Umbrella trials
  • Platform trials
  • Extending beyond umbrella, basket, and platform trials

Practical 1: Computer based practical session based on lectures 1 -2

Break

Lecture 3 – Borrowing information in basket and umbrella trials

  • Rationale for borrowing information
  • Methods for Borrowing of information between modules/subtrials

Lecture 4 – Using high-dimensional information in clinical trials

  • High-dimensional information and its increasing role in clinical trials
  • Retrospective analysis of high-dimensional subgroup information
  • Adaptive signature design and extensions
  • Future research

Practical 2: Computer based practical sessions for lectures 3-4


To get the best value out of the practical sessions it is recommended to have a laptop with an R installation available.
However, attendance at the training is also possible and successful without a laptop with an R installation.

Statisticians with an interest in clinical trials will benefit the most from this course. Clinicians and trialists with good knowledge of statistics and computing will follow much of the course and will be exposed to a range of potential new methods. With the practical, participants will have a chance to implement the novel methods in concrete examples.
Good knowledge of statistical theory or R software is of advantage to follow some of the course content including the practical sessions.

Participant experience
We will assume good knowledge of clinical trial designs and statistical approaches to analysing them. Knowledge of R software is of advantage for the practical sessions.

A mix of lectures and practical sessions

Lecturers
James Wason
Info

James Wason

Professor of Biostatistics, Biostatistics Research Group, Newcastle University

James Wason, PhD has been a Professor of Biostatistics at Newcastle University since 2017. He leads the Biostatistics Research Group which develops and applies innovative statistical methodology for improving the design and analysis of clinical trials. His interests include adaptive clinical trial design, clinical trials in the era of precision medicine, and improving the analysis of composite outcomes. He currently is a NIHR Research Professor, leading development of innovative trial designs for immune-mediated inflammatory diseases. He has authored over 150 publications in a range of statistical and clinical journals. He also has  strong experience in applying methods in real trials and consulting to small and large pharmaceutical company clients.


Luke Ouma
Info

Luke Ouma

Research Associate (Biostatistics), Biostatistics research group, Faculty of Medical sciences, Newcastle University

Luke earned a PhD in statistical methodology for basket and umbrella trials from Newcastle University. Currently, he works as a research associate in Prof James Wason’s group at Newcastle University where he is involved in developing improved methods for the design and analysis of innovative trial designs in precision medicine. His methodological research focuses mainly on Bayesian methods in trial design and analysis, and he’s interested in the application of basket, umbrella and platform trial designs in non-oncology settings.


13 November 2023
from 13:30 to 17:30 – 4 hrs with a coffee-break midway

Training venue:
NH Collection München Bavaria

Arnulfstr. 2, 80335 Munich

The NH Collection München Bavaria is located in the city center next to the main train station, and only steps away from the old town, it offers easy access to all of Munich, making it an ideal base for business visitors.

From the airport
Train: Take the S1 or S8 from the Munich Airport, which departs every 5 – 10 minutes, to get to the central station “München Hauptbahnhof”. From there, please alight in the direction of Arnulfstraße. The hotel is located on the opposite side of the street. Total trip time is around 45 minutes.
Taxi: It is a 30-40 minutes trip

From the train station
München Hauptbahnhof: From there, please alight in the direction of Arnulfstraße. The hotel is located on the opposite side of the street.
Closest metro station: München Hauptbahnhof


The course will proceed with a minimum number of participants.
Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Early Bird: € 510,00* until 17/10/2023

Ordinary: € 610,00*

Freelance – Academy – Public Administration**: € 310,00*

* for Italian companies: +22% VAT

**Early Bird discount not applicable to Freelance – Academy – Public Administration fee

The fee includes: seat at the training, training material, coffee break, organisational office assistance, certificate of attendance.

Register

Ticket not available


Printable Version
At the end of the training, you will be able to
Risultato atteso
Understand the role of innovative designs in precision medicine, the key statistical issues they raise and the need for more efficient methods
Risultato atteso
Implement novel methods for the design and analysis of precision medicine trials
Risultato atteso
Know some future directions of research in the area

<p style="text-align: center;"><strong>NH Collection München Bavaria</strong><br />
<span>Arnulfstr. 2</span><br />
<span>80335 Munich – Germany</span></p>

NH Collection München Bavaria
Arnulfstr. 2
80335 Munich – Germany

<p style="text-align: center;"><strong>NH Collection München Bavaria</strong><br />
<span>Arnulfstr. 2</span><br />
<span>80335 Munich – Germany</span></p>
<p style="text-align: center;"><strong>NH Collection München Bavaria</strong><br />
<span>Arnulfstr. 2</span><br />
<span>80335 Munich – Germany</span></p>
<p style="text-align: center;"><strong>NH Collection München Bavaria</strong><br />
<span>Arnulfstr. 2</span><br />
<span>80335 Munich – Germany</span></p>