Clinical trials to evaluate and validate infrastructure of P-medicine consortium

Retrospective and prospective clinical trials will be run to evaluate and validate the infrastructure of the P-medicine consortium, announced a poster at the recent 3rd symposium of the Worldwide Innovative Networking in Personalized Cancer Medicine, held in Paris 6-8 July, 2011. 

A report, published Wednesday in ecancermedicalscience, provides an overview of both the poster and the main findings of the meeting. The P-medicine consortium, a four year project funded by the European Community's 7th Framework Programme, was founded to facilitate the development of new tools, IT infrastructure and Virtual Physiological Models (VPH) to accelerate personalized medicine for the benefit of patients. 

The consortium is composed of a heterogeneous group of experts including clinicians, bioinformaticians, software developers, data miners and legal attorney defining specific scenarios to test tools of the P-medicine infrastructure. 

The article outlines the three trials that have been selected - a Wilms tumour trial, a phase II neoadjuvant pharmacodynamic breast cancer trial, and a leukaemia trial. The leukaemia trial will be used to develop and run a VPH model predicting minimal residual disease and recurrence in childhood acute lymphoblastic leukaemia. 

The poster illustrated how the consortium is defining specific scenarios that can be used to test the P-medicine infrastructure. Expression data from uveal primary tumours was one example given, where half the patients went on to develop metastases and half did not, allowing information on differentially expressed genes to be extracted and survival analysis performed. 

From this situation different views were identified including clinicians who would like to be able to ascertain the expected prognosis of a new patient, the data miner who would like to perform literature mining and patients who would require practical explanations to enable them to be part of the decision making process. 

The overall symposium acknowledged that patients are ready to be engaged, but recognised that that presentation of the available options would represent a challenge. Other key discussions included the fact that biomarker driven therapy was not reimbursed in most countries, and that with so many targets now available it was important for the research community to decide with which it wants to move forward to transform biomarkers into clinical practice. 

Prof Richard Schilsky from the University of Chicago, US, concluded the meeting by listing the areas that require attention, including the optimal combination of agents, how to integrate datasets, convert lab assays into clinical tests, define phenotypes and how to convey results to physicians in a useful format.