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Design of clinical trials with biologics

Research Objectives:

Biologics such as monoclonal antibodies are increasingly and successfully used for the treatment of many diseases. Unlike conventional small drug molecules, which are commonly given as tablets once daily, biologics are typically injected at much longer time intervals, i.e. weeks or months. Hence both the dose and the time interval have to be optimized during the drug development process for biologics. Individualized patient specific dosing and timing (personalized medicine) may also be needed to maximize benefit for the patient, or to increase cost effectiveness. Research on how to design clinical trials with biologics is sparse, and it is likely that currently used trial designs are not optimal. Hence any advance in this field would tend to decrease drug development time, and bring beneficial drugs earlier to patients.

Description of work:

The focus of the research should be the development of novel adaptive trial designs, tailored to clinical trials with biologics. The trial designs should allow to efficiently identify adequate regimens for the investigated biologic. Adaptations could for example include a change in the dose or the length of the dosing interval for individual patients. The adaptations would be based on interim data from the ongoing trial. This would typically involve use of a model, such as a semi-mechanistic nonlinear mixed effect model (K-PD model). Bayesian methods would then allow to update the model based on interim data, and make use of this for the adaptations.

Host Institution: Novartis

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