Theme 1

Early phase trial design and analysis.

Co-theme leaders Dr Thomas Jaki and Dr Lisa Hampson (Lancaster University)

Early phase trials lend themselves to adaptive procedures which allow the research to proceed in stages, with design decisions being taken after the completion of each one. Bayesian methods may be utilised, in which prior information is incorporated and updated by data as they accumulate. The objective of the research group is to promote, modify and implement recently devised methods for Phase I dose escalation studies, Phase II proof of concept studies and Phase I/II combination designs. Additionally, methods for the early determination of the cost-effectiveness of medicines are being developed, including the use of clinical trial simulation (based on PKPD).

Two PhD projects within this theme include ‘Bayesian designs for phase I studies in cancer’ and ‘Methodology for the early (pre-market authorisation) determination of the economic value of medicines’.