Through the integration of clinical trials into a single governance framework, thereby integrating cancer research within the NHS the Edinburgh ECMC has achieved its primary objectives by judicious use of e-science to underpin both clinical trials and translational research alike. Thus molecular pathology is established as a platform upon which both basic science and clinical medicine are brought together, supported through new technologies, leading to novel biomarkers for diagnosis, prognosis, prediction of treatment response and novel targets for drugs of the future. This brings patient benefit to both current patients taking part in clinical trials and research and future patients through an increased understanding of the mechanisms of cancer pathways and the promise of personalised treatments.

A cancer specific governance framework has led to faster approvals of trials, rapid response times to address potential issues, and better use of limited resources, hereby increasing the number of trials opened and increased patient recruitment. This framework has enabled the centre to apply the successes from individual areas (e.g. enormous activity in translational research in breast cancer) to others (e.g. Ovarian & Prostate and Urological cancers in general), and is now expanded to areas previously neglected (e.g. Pancreas). This framework enables the centre to bring together investigators from a variety of clinical backgrounds and research settings by giving them the tools they need, encourage collaboration and providing technical support under a single quality assurance system covering all aspects of cancer clinical trials and translational research.

Edinburgh ECMC has made considerable progress in the development of databases for clinical and biological datasets linked to specimens which are tracked in a fit for purpose sample management system. Linking to NHS Scotland ISD, a unique resource, which enables investigators to query data previously unavailable to them. This e-science programme enables researchers to stratify patient groups for experimental research and in particular biomarker discovery. The Breast and Ovarian Cancer Databases have been of crucial importance for the selection of cohorts of patients/specimens which have resulted in several high profile publications. The more recent Urological and Colorectal Cancer Databases have proven invaluable for translational research programmes set up in those areas.

Edinburgh ECMC has currently in its repository 8043 fresh frozen breast cancer samples from approximately 5500 patients, 2110 fresh frozen colorectal samples and 3800 colorectal FFPE blocks, and an even larger collection of other FFPE blocks. To date this invaluable resource has been used for over a hundred individual translational research projects. In 2009 alone 57 tissue requests were granted of which 10 were from outside Lothian. We have also facilitated collection and processing of samples for early phase clinical trials.

The establishment of databases with comprehensive clinical datasets which are linked to a large collection of specimens available for biomarker discovery as well as the local availability of novel technologies has made biomarker discovery a major area of interest in Edinburgh.
By measuring morphological parameters such as tumour stage and grade, and by measuring molecular biomarkers such as hormone receptor status, pathologists have sometimes accurately predicted what will happen to a patient's tumour. While 'omic' technologies have seemingly improved prognostication and prediction, some molecular 'signatures' are not useful in clinical practice because of the failure to independently validate these approaches. Many associations between gene 'signatures' and clinical response are correlative rather than mechanistic, and such associations are poor predictors of how cellular biochemical networks will behave in perturbed, diseased cells. ECMC investigators have integrated multiple data from the clinic into tractable models using mathematical models and systems biology, and have made these sufficiently robust to be of practical use, and are now developing approaches that may be used to allow systems biology to be successfully applied in the clinic.

ECMC support for Oncology Medical Physics has proven very successful for the removal of bottlenecks for radiotherapy and radiology support for clinical trials. In the past 6 months 5 clinical trials have opened (Spare, Radicals, Scope, EORTC22042 & Herceptin PCI) which had been envisaged to be delayed by a further half year. A further 8 trials are currently pending as a direct consequence of ECMC funding.

The efforts of the Edinburgh ECMC coordinating office to support early phase clinical trials and translational studies with quality assured biospecimens collections linked to high quality clinical datasets have culminated last September in Edinburgh ECMC passing GCP for Laboratory (GCLP) inspection by the MHRA. Efforts to support clinical trials and translational research in other cancers culminated with Edinburgh passing a JACIE inspection last November.