This is a key module for students on the MSc Programme and might also be taken by other MSc, MBioSci and MRes students whose interests include experimental medicine and testing drugs in humans for the first time.
The module will address the early phase clinical trial period, encompassing phase I and II of the drug development pipeline, which seeks to determine the safe dose of a novel treatment that has the most promise to be effective. The methodology is distinct from that of later phase effectiveness trials (phase III onwards).
The module includes research connected lectures, practicals, and workshops with structured discussions on selected texts as student-led topics. The content will focus on methods for dose-finding and early efficacy studies. The module assessments are aimed at: 1) writing a report on a selected investigational product and the methods for dose finding 2) presentation of a key factor that contributes to the determination and management of risk. The factor focused on will be selected from workshops and student-led discussions. Students will acquire a good understanding of the theoretical underpinning early-phase dose-determining clinical trials. By the end of the module, students should have the knowledge and skills required to interpret pre-clinical data sufficient to plan, and manage, a phase I clinical trial