Goals
- The centre will take ideas from laboratory programs and develop these into clinical studies. This will include development of novel agents and using biological markers to optimise, target and individualise treatment.
- We would expect in the timescale of this grant to have at least two further projects with funding from the development committee and/or NAC.
- We would expect to have lead role in at least two additional phase I/II protocols that use biological endpoints assayed through ASU to determine recommended dose and schedule for further development of novel agents.
- We would expect to have at least two phase II/III studies underway which use biomarkers as one of the primary selection criteria for treatment.
- In the SCOTROC trials and associated translational studies we have shown our capability to lead the clinical and scientific field. Glasgow is the co-ordinating centre for the clinical studies and is also the hub for all sample collection and analysis. As an example we have collected over 950 blood and plasma samples from patients in over 80 centres throughout the world in the SCOTROC 1 trial.
- In the forthcoming DAC-Carbo phase 2 trials, Glasgow will be the lead laboratory responsible for conducting and co-ordinating a range of PD and PK objectives, including using DNA methylation to identify suitable patients for this therapy. This will be a multicentre randomised phase II recruiting 134 patients with multiple samples being taken from each subject.
- Up till now the ASU has been used as an internal resource. However, we view this expertise and service becoming more accessible to other Cancer Research UK units and ECMCs with expansion in the future.
- We are aware of the NCRI Informatics platform and Co-ordination Unit and expect our enhanced bio-informatics capacity and expertise would allow us to take a more active role in this initiative.
- We seek additional positions to facilitate patient recruitment, sample collection and near patient handling of specimens as well as coordination of this process in our own centre. We plan that this expertise will also be required in other centres with which we are performing complex studies which include primary or secondary PD and PK objectives.