As medicines become more personalised, drug development processes become more precise. It will soon be common to conduct Phase I trials directly with the target population bypassing the typical trials with healthy volunteers. Not only does this mean that less volunteers are needed in the drug development process, but the development time is reduced - as are the associated costs.
It is important to remain cautious when embarking on a Phase I trial with patients. The long established and robust tool kit that is applied to healthy volunteer trials will not be transferable to patient populations where their medical conditions or co-morbidities may cause them to react differently to medicines, the usual biomarkers no longer apply.
Principal Investigators must use all available, relevant data when conducting the trial. It is crucial to learn from non-clinical data ensuring all known risks are managed before first in human trials commence. Patients must be fully informed of the risks before consenting to participate.
Richmond Research Institute was born out of a partnership with St Georges University of London. The Institute is a not-for-profit organisation dedicated to drug safety research to improve and save lives. Our world-class research aims to explore the usefulness of potential new medicines, assesses the safety of existing medicinal products, provides the scientific insights to improve clinical trial methodologies and strategies for personalised medicines.
We studied the cardiac safety of P218 using advanced QTc assessments and found doses of up to 1000mg do not prolong the QTc suggesting a low risk of drug induced arrhythmia.
Here we present the results of our recent work on the cardiac safety of cortexolone 17α-propionate (cortexolone).
12-lead resting ECGs are considered essential in clinical trials, but their limitations have led to increasing use of 12-lead Holter monitor devices.
Here we report our recent work on the cardiac safety of nolasiban.
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