Imaging, such as MRI, CT, PET provide specific biomarkers for to support patient stratification, to inform trial protocol and trial design, to provide information for modelling of pharmacokinetics and pharmacodynamics and to predict drug response early.
Most importantly, as we often deal with drug combinations and advanced therapies, the imaging allows reliably and non-invasively monitor short-, mid- and long-term therapeutic outcomes. Which imaging biomarker to use in your trial will depend on which question needs to be answered. Read more about particular therapeutic areas and the relevant biomarkers.
In early drug development phases, imaging is needed to answer specific questions around whether the new drug candidate reaches the target and, if so, in sufficient quantity or whether the expected mechanism of action can be observed.
A number of innovative methodologies, including those based on AI and Machine Learning have been used in trial. Finding the right imaging biomarker will allow for much faster assessment of therapeutic efficacy of a new treatment and making early go / no go decisions.
When planning a trial, one must make critical choices on whether to use imaging as a surrogate endpoint and how to link imaging based and clinical outcomes.
At IAG, we leverage 10 years of expertise in advanced image analysis, global footprint and many imaging methodologies, which have been used in ph I/II-III trials to accelerate and to support drug development, to de-risk trial execution and to ensure integrity and scientific credibility of your data.