Early Phase Clinical Development

Typically an early phase trial protocol utilises inclusion criteria to ensure correct patient enrolment. There can be uncertainty in determining disease stage and/or differential diagnosis and imaging can be utilised to provide complementary markers (through visual radiological assessment and quantitative image analysis) for clinical trial enrichment in CNS therapeutic areas.

In early phase trial design, you want to obtain the best quality endpoint data, together with a flexible design to allow extraction of as much exploratory information as possible, but also to ensure the imaging sessions are within the limits of patient ability/tolerance. IXICO are experienced in supporting protocol development that optimises scanning protocols, sequences and endpoints.

It is often a requirement to explore a number of exploratory endpoints including new and novel data analytics. IXICO continuously adds to and advances the available analysis pipelines, looking at disease-specific regions of interest, indices, and other endpoints. It is important to ensure full validation and rigor around data collection, to enable use and translation into later-phase submission trials.

Early phase development can benefit from engagement with the wider research community through collaborations and consortia.  IXICO's collaborations with international Consortia, academic Institutions and global networks of research sites harnesses the best in imaging and other data science expertise to define, develop and validate therapeutic area specific imaging and digital endpoints in rare diseases.