Clinical trials are vital to treatment development and recruit over 20,000 patients per year in the UK, generating significant volumes of pathological data and patient samples, many of which are underutilised. This talk will present an overview of how a clinical trial is set up and the different roles the pathologist can fulfil in trial design, governance of sample processing and data quality as well as the wider opportunities for translational research.

Several recent clinical trials provide examples of the role of pathology in generating data in and how a pathology perspective can influence trial results. The publication of the SPIRIT-Path extension guidelines in 2021 has provided a framework for pathology involvement but these are not being widely adopted within clinical trials units.

Looking towards the future there is a need for support and training for pathologists to improve involvement in clinical trials and biomarker research. We will look at the role of the Clinical Trial Pathology Advisory Group (CT-PAG) and the Open Lab Initiative in enabling pathology engagement with clinical trial research.
 

Maggie will discuss the various applications of technologies for biomarker research on FFPE materials, in particular the integration of multi-omics data from – using breast cancer studies as the main examples. She will share the various challenges and considerations taken in the study design and analytical methodologies when developing clinically relevant biomarker classifiers. She will briefly discuss several aspects to be considered when planning a translational biomarker study with objectives to identify and develop genomics assays for sub-classification of tumours, and to determine the sensitivity of each tumour type to therapeutic agents and targeted therapies.