Designing Phase I Dose Escalation Studies
Date: 12th - 13th Jun 2017
Duration: 2.0 days
Delivered by: Dr Phillip Pallmann & Dr Thomas Jaki
Registration deadline: Monday 5th June
The course fees include all supporting documentation and refreshments.
- External from industry/commerce - £540
- External from academic institution/public sector/charity - £460
- External postgraduate student - £300
- Members of Lancaster University - £0
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. Dose-escalation studies are first-in-human studies intending to determine a safe dose or range of doses which can be taken forward for further development. 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 a potential benefit.
This course presents state of the art methodology for dose-escalation studies. The course will be delivered through a mixture of lectures, practical sessions and discussion sessions.
- Model-based dose-escalation in oncology
- Dose-escalation in healthy-volunteer studies
- Bayesian curve-free dose-escalation for drug combinations
- Dose-escalation designs incorporating multiple endpoints.
Students will be able to:
Registrations are transferable to another course or individual at any time. Full refunds will be given for cancellation 10 or more working days before the course start date. Otherwise the full course fee will be charged.