Lizzi graduated from the University of Bath in 2016 with a BSc in Mathematics and Statistics which included a placement year working as a statistician within a research unit of a global pharmaceutical company. This developed her interest in statistics, particularly applied to medical and pharmaceutical problems, and led to further work experience in the field. Lizzi also enjoys dancing, running, yoga, learning languages and visiting family and friends.

Research project title:
Optimising First in Human trials

Supervisor(s):
Chris Jennison, Chris Harbron

Project description:
Lizzi’s project involved developing the statistical methodology used to design and make decisions in Phase I/First in Human clinical trials and was in collaboration with Roche. This type of trial is the first stage in testing a potential new treatment in humans, after extensive laboratory testing. The primary aim is to establish the associated safety and tolerability in order to define the range of doses to be tested in phase II. Clinical trials are expensive and time consuming, thus research into optimising this process aims to reduce the number of people required, the duration and the cost. Lizzi’s research addresses the topic of trial design from a different angle to most of the literature, putting the focus on clearly defining the aims of a specific trial up front and finding the design that is optimal with respect to those aims. This is achieved through exact and approximate dynamic programming. Lizzi investigated properties of trial designs through simulation to ensure a design was both statistically robust and fit for practical use, thus appealing to clinicians. She compared properties to those of existing model-based Bayesian dose finding methodology such as the Continual Reassessment Method. Traditionally, at this stage of the drug development process there is no evaluation of whether or not the treatment works. Lizzi’s research therefore incorporated analysing an early signal of efficacy into the trial design.