Introduzione
Clinical trials are the gold standard study design for producing high-quality evidence and are a regulatory requirement for evaluating the safety and efficacy of drugs and medical devices.
They are very expensive and time-consuming to conduct and therefore design methods for making them more efficient are very important.
This course provides an overview of three main types of innovative study design:
1) adaptive trials;
2) master protocols (basket, platform, and umbrella designs);
3) designs that allow using external information to augment the trial, including synthetic control methods and Bayesian borrowing.
The course keeps statistical theory to an absolute minimum. Case studies are provided for each type of innovative design and focus placed on operational and regulatory issues as well as statistical issues.
Day 1 – Adaptive trial designs
- Introductions and overview of course
- Overview of adaptive trial designs, principles and examples
- Multi-arm multi-stage trials
- Small group activity
- Implementing adaptive trials in practice
- Software showcase
Day 2 – Master protocol designs
- Overview of master protocols – basket and umbrella trials
- Platform trials
- Practical and regulatory considerations in implementing master protocols
- Small group discussion of case studies
- Reporting of small group discussion
Day 3 – Using external information in clinical trials
- Why use external sources of information in trials?
- Bayesian approaches for borrowing information
- Synthetic control methods
- Small group activity
- Regulatory views on using external sources of information in trials
The course would be suitable for an individual aiming to improve their knowledge about different study designs available and the issues involved in implementing them in practice.
The workshop will take place over three half days. Each half-day will focus on a different type of innovative trial design. The workshop will be a mixture of lectures, small-group case-study discussions, and software demonstrations.
Docente/i
James Wason
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.
Online training – 3 modules
MODULE 1 | 19 June 2025 from 02:00 pm to 05:30 pm CEST
MODULE 2 | 23 June 2025 from 02:00 pm to 05:30 pm CEST
MODULE 3 | 25 June 2025 from 02:00 pm to 05:30 pm CEST
After the registration, you will receive all details about the connection.
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: € 990,00* (until 29 May 2025)
Ordinary: € 1.190,00*
Freelance – Individual – Academy – Public Administration**: € 670,00*
* for Italian companies: +22% VAT
**Early Bird discount not applicable to Freelance – Individual – Academy – Public Administration fee
The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.
