Early phase clinical trials - July 5th to July 9th

Date:

July 5th to July 9th. Morning from 9.00 to 12.00h

Classroom:

005

Modality:

Face-to -Face  or Streaming

Instructor

Thomas Jaki

Thomas Jaki is Programme Leader at the MRC Biostatistics Unit at the University of Cambridge and Professor of Statistics at Lancaster University with a particular interest in efficient clinical trial designs.  He is the director of the Medical and Pharmaceutical research unit which has a long lasting tradition in the design and analysis of clinical trials.

His methodological research to date has focused on adaptive designs and multiplicity, Bayesian methods and estimation with sparse data. He has worked on estimators for pharmacokinetic parameters, developed adaptive designs – in particular for multi-arm studies - and investigated Bayesian methods for dose-escalation.

Language

English

Description

The importance of exploratory clinical research prior to the launch of a large-scale definitive “phase III” clinical trial is becoming increasingly recognised, both in the pharmaceutical industry and in public sector medical research.

Early phase trials include first-in-human studies intended to determine a safe dose or range of doses, studies to identify the most effective dose and trials on which a decision whether or not to launch a phase III study will depend. Advances in the identification of medical biomarkers of therapeutic effect and in statistical techniques based on adaptive designs and Bayesian inference now allow such studies to be designed efficiently, to take account of information from a variety of sources and to combine objectives such as establishing safety and seeking evidence of potential benefit.
This course presents state of the art methodology for dose-escalation studies and tailor made designs for phase II investigations.

The course will be delivered through a mix of lectures, practical sessions and discussion sessions.

Course goals

To provide an introductory overview of different designs for Phase I and Phase II clincial trials.

Course contents

1. Model-based dose-escalation in Oncology
2. Dose-escalation in Healthy-Volunteer studies
3. Dose-escalation for drug combinations
4. MCP-MOD
5. Master protocols

Prerequisites

Understanding of regression models, hypothesis testing. Basic knowledge of Bayesian methods.

Targeted at

Clinical trialists and Medical statisticians

Evaluation

Project

Computer class or student's laptop?

Student's laptop

Software requirements

R