This research project is about finding “better, faster, cheaper” ways to conduct Multiple Ascending Dose (MAD) trials using Bayesian adaptive designs in combination with other emerging approaches in early development, such as the use of extemporaneous formulations and “umbrella protocols” combining several objectives in a single clinical study. This research will bring together the long standing expertise of a leading academic group in the statistical science of Bayesian adaptive designs and the Roche experience (in the department of Biostatistics and Clinical Pharmacology) in the conduct of MAD trials in early drug development. This collaboration is expected to lead to significant improvements in the way we perform early clinical development, hence making Roche more competitive.

Finding a suitable dose for use in confirmatory trials of new drugs is crucial to the success of clinical research. Devoting more time and effort to this phase of investigation will reduce the number of drug development programmes that fail to demonstrate efficacy and will therefore justify additional investment. This proposal concerns the development of a new and flexible strategy for the conduct of multiple ascending dose studies that will be more efficient, more informative and more accurate in their indication of which drugs to take forward to large scale confirmatory trials.