Phase I and II clinical trials
Cancer Research UK has a well established world-class clinical trial network of Phase I and II expert centres throughout the UK. This includes 14 major oncology centres in the UK many of which have internationally renowned early clinical trial experts as their lead. All centres have the infrastructure and expertise for carrying out high quality Phase I (first in patient) and Phase II clinical trials.
Access to leading edge technologies and expert scientists in the centres ensures that all studies produce quality proof of principle data. Cancer Research UK works with these centres to ensure they work to appropriate quality standards to ensure regulatory compliance and the robustness of this data.
Using its extensive clinical network, staff, facilities and where necessary CROs, Cancer Research UK's Drug Development Office (DDO) can manage and execute drug development and early phase trials, from scale-up production to final report on the clinical trial. The DDO has over 50 well-trained and experienced in-house staff for managing, monitoring and reporting the trials and dealing with regulatory requirements. All studies are conducted in line with current legal and regulatory requirements. Updates on the clinical trial will be provided to the company during the course of the study and a final clinical report prepared on completion.
Non-clinical safety studies, formulation development and final-product manufacture can also be undertaken in the in-house facilities or contracted out if required. Cancer Research UK has two production facilities, both licensed for GMP production of investigational medicinal products. One produces small molecule drugs, the Formulation Unit, and the other biological agents, the Biotherapeutics Development Unit.
The clinical network and DDO have significant expertise in running early phase clinical trials, especially 'first in man' studies. DDO has worked on a diverse range of agents from small molecules to gene therapy and vaccine studies. The normal portfolio consists of more than twenty different novel agents in clinical trial at any one time.
