This course will take place on Sunday 14th May from 14:00. You can register your place through the conference registration system.
Early Phase Decision Making and Trial Design
James Matcham, Head ECD Biometrics, AstraZeneca
Alun Bedding, Associate Director, Roche
The objective of this short course is to provide a review of the main concepts of design and analysis used within early phase clinical trials. The course will provide an update on the clinical trial designs used (including adaptive designs), quantitative decision making and precision medicine/biomarkers in the early phase.
The course presenters are both currently working in Early Clinical Development at their respective companies and between them have extensive experience in the design and conduct of these trials.
The objectives of early phase clinical trials are to test the safety and tolerability of a new medicine and whether the pre-clinical promise of a potential new medicine translates to human subjects.
At the end of this short course participants will know the main concepts used within early phase clinical trials. During the course the following concepts will be described, and where possible, examples will be given:
Safety, proof of mechanism (POM), pharmacokinetics (PK), pharmacodynamics (PD), route of administration, proof of concept (POC), decision making, fixed design trials, adaptive design trials
This course will be given by James Matcham (AstraZeneca), and Alun Bedding (Roche), who are both working in Early Clinical Development at their respective companies and between them have extensive experience in the conduct of these trials.
1. Objectives of Early Phase Trials
- Establishing safety and tolerability in human subjects, with a word about the TGN1412 study
- Single and multiple dose PK
- Dose proportionality, bioavailability and bioequivalence
- Drug-drug interactions studies (DDI)
- Food effect studies
2. Decision making in early phase clinical trials
3. Design of early phase clinical trials
- Fixed design trials
- Bioequivalence/DDI/food effect
- Single and multiple ascending dose trials
- Dose escalation
- Continual reassessment methods
- Methods for univariate and bivariate endpoints
- Other Bayesian methods used in early phase trials
4. Precision medicine and biomarkers
- Establishing and validating biomarkers
5. Preparing for phase 2A
- Early Phase Endpoints
- Role of interim analyses
- Adaptive Designs
- Trial Simulation
In this short course many references for further reading will be provided.