The Adult Drug Development Unit at the ICR and the RM

Opened in February 2005, the DDU Ward is a purpose-designed Phase I clinical trials facility within the Royal Marsden. It provides seven day-care treatment chairs, two outpatient suites, and Oak Ward – a ten-bed inpatient ward, including two single en-suite rooms with negative pressure. The unit is staffed 24-hours a day, for at least five days a week. Based within the main body of the hospital, the unit is fully integrated with the full spectrum of clinical and support services, including the full support of the hospital’s Critical Care Team with whom we work very closely and have established standard operating procedures, for example in managing cytokine release syndrome toxicities.

The DDU provides a comprehensive clinical trials pharmacy service with dedicated Trials Pharmacist and Pharmacy Trials Technician staff. The Pharmacy team works closely with study teams on a day-to-day basis to ensure smooth delivery of trial services within our early phase centre.

The analytic laboratory at the DDU is staffed by laboratory technicians and supported by a dedicated pharmacodynamics sample collection team based in the ICR. The laboratory facilitates pharmacokinetics and pharmacodynamics processing, tracking, storage and shipment to protocol requirements. The DDU has capabilities to analyse a range of biomarker samples including hair follicle, skin and archival and fresh tumour biopsies, and are able to provide sections from formalin fixed paraffin embedded (FFPE) archival tissue samples or frozen samples. On-site analysis facilities include:

• Histopathology: immunohistochemistry, multi-colour immunofluorescence, fluorescence in situ hybridisation (FISH), chromogenic ISH, nucleic acid extraction from tumour tissue for DNA and mRNA analyses and tissue microarray including RNAish.
• Next generation sequencing: Illumina and Ion Torrent platforms. All referred patients have their tumours evaluated with a targeted sequencing panel determining mutation analyses and gene copy number with expert bioinformatic support.
• Circulating biomarker expertise: analysis of plasma DNA, circulating tumour cells, exosomes, white blood cell immunophenotyping and whole blood mRNA analyses.

We routinely seek to recruit newly referred DDU patients into molecular characterisation studies whereby patients consent to retrieval of archival and/or fresh tumour tissue for molecular testing. The clinical pharmacodynamics research group develops and runs bespoke complex pharmacodynamic assays that are crucial to the development of targeted anti-cancer drugs. They conduct these in academic and pharmaceutical company run Phase I studies.

The Radiology department has full access to MRI, CT, PET-CT, US, and general nuclear medicine (for bone and multi-gated acquisition [MUGA] scans) facilities. Our imaging department is augmented by collaboration with research teams with a special interest in translational functional imaging at the Cancer Research UK Cancer Imaging Centre and the NIHR Cancer Imaging Clinical Research Facility (CRF). The clinical team includes dedicated experienced radiologists, nuclear medicine physicians, medical physicists and research radiographers. We have cyclotrons on site supporting PET imaging. Our team has extensive expertise in translational imaging studies utilizing PET with tracers like Zirconium and whole body MRI, as well as with magnetic resonance spectroscopy.

Our team is fully equipped to support remote monitoring of site activities. We are able to hold remote Site feasibilities and SIVs. Our digital infrastructure provides a comprehensive, regulatory compliant and bespoke solution to enable remote verification of source data.