The Drug Development Unit (DDU) at The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London, comprises an internationally-leading group of >100 staff focused on early anti-cancer drug development. The DDU is at the forefront of clinical and translational cancer research and provides a key link between laboratory and clinic. It benefits from its position between the two institutions, allowing for the evaluation of a broad spectrum of novel anti-cancer agents. The DDU aims to serve as many to serve as many patients as possible with diverse tumour types.
Together, as a group, we have conducted more than 500 early clinical trials, and have extensive experience in the design, regulatory submission and approval, conduct and delivery of early clinical trials for cancer patients. We have been conducting between 20 and 50 Phase 1 trials every year for over 15-years in our DDU including many investigator-initiated Phase 1 trials.
Our unit includes a separate group dedicated to sponsoring such academically sponsored trials. We also have radiology and pathology staff dedicated to our unit, as well as statistical support including access to senior statistical expertise in adaptive and Bayesian, model-based, dose-finding trials. A major focus of our group is developing methods to improve Phase 1 clinical trial designs, with a focus on the use of the Pharmacological Audit Trail, patient-reported outcomes, and making these intensive clinical trials less onerous to patient.
These trials are conducted in a purpose-built ward in The Royal Marsden; this 10-bed ward with in-patient 24-hour facilities and an outpatient facility is fully dedicated to Phase 1 clinical trials for cancer patients. It was opened in 2005, and includes single en-suite rooms for trials that require patient isolation such as oncolytic viral therapy trials for which we have established standard operating procedures. This bespoke unit fully supports the delivery of first-in-human, proof of concept, innovative clinical trials.
Our clinical trials also pursue the conduct of translational biomarker studies using, for example, next generation sequencing of tissue or liquid samples, uniplex and/or multiplex immunocytochemistry, FISH or CISH and RNAish of tumour material acquired from biopsies in our cancer biomarker laboratories. We also have extensive experience in genomic analyses of circulating tumour DNA and circulating tumour cells and utilizing apheresis as a liquid biopsy. Our overall goal is to identify as early as possible in clinical development predictive biomarkers defining which patient population the drug or drug combination can benefit.
Our clinical pharmacodynamics biomarker laboratory group, which establishes highly validated assays, operates to rigorous standard operating procedures, and works to GCP standards, is key to setting up and performing pharmacodynamics assays in normal tissue and tumour to evaluate target engagement, information that is crucial to recommending the dose and schedule of targeted agents.
Our Investigator-Initiated Trials (IIT) group (Sponsoring Group), which was established in 2012, delivers the DDU’s academically sponsored Phase I trials portfolio and has run more than 15 such trials over the last 5-years. This work is conducted in partnership with The ICR Clinical Trials and Statistics Unit (CTSU).
This group is comprised of skilled clinical research professionals to support all trials from initial discussions of trial concept, through to clinical trial protocol design and development, electronic database generation, regulatory submissions, day-to-day trial management and monitoring, data analyses and reporting, all focused on the timely delivery of high-quality ICH-GCP-compliant studies. The group brings together clinical translational scientists and biostatisticians to apply adaptive trial designs to biomarker-led early phase trials for the benefit of cancer patients.
In collaboration with commercial and academic partners our aim is to take forward promising novel anti-cancer therapeutic strategies and investigational medicinal products, including novel agents discovered at The ICR, or drug combinations which may otherwise not progress through to clinical trials. DDU’s investigator-initiated trials group fully support the operational delivery of Phase I trials from initial discussions of trial concept, through to protocol design and development, regulatory submissions, management and monitoring, to analysis and reporting.