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This module covers the following areas: principles of research governance, phases of drug development, data management and safety measures in early phase clinical trials, biomarkers and surrogate markers of pharmacodynamic action and efficacy, principles of pharmacokinetic, emerging technologies and examples of innovative trials in key neurological and neurodegenerative diseases.

The aim of this module is to provide you with an understanding of the challenges in undertaking early phases clinical trials for neurological indications and how to overcome them. This module will train you to have a rational approach to clinical research and the correct design and implementation of early phase clinical trials aiming at:

Translating preclinical data into first-in-human clinical trials

Evaluating the therapeutic potential of putative new drugs in the most appropriate patient populations
Optimising dosing regimen through established PK/PD relationships
Demonstrating that the molecule under testing has the desired pharmacology therefore is capable of confirming the biologic hypothesis underpinning its development
Increasing confidence in the scientific and clinical basis for the potential efficacy of new therapies and their likely impact on the mechanisms of disease.
This material provides the theoretical basis for topics explored in other modules on the programme.

At the end of the module you will have an understanding of translational medicine as it relates to neuroscience, as well as the principles and regulations underpinning clinical research from early stage trials through to licensed therapeutics. You will be able to demonstrate understanding of all the key components of successful research projects in neurological diseases including ethical considerations, study set-up, protocol development and implementation through to data analysis and reporting.