Post-genomic clinical trials - the perspective of ACGT

Abstract

During the last few years, the ‘omics’ revolution has dramatically increased the amount of data available for characterizing intracellular events. As a result, a lot of patterns of gene expression were found that could be used to classify molecular subtypes of tumours and predict the outcome and response to treatment. Currently, the main focus is on interlinking the various data sources generated by high-throughput array technologies. Various groups have applied network analysis to gene data sets associated with cancer. ACGT, a project funded by the European Commission in the Sixth Framework Programme, goes far beyond these networks by the integration of clinical data. The ultimate objective of the ACGT project is the provision of a unified technological infrastructure, which will facilitate the seamless and secure access and analysis of multi- level clinical and genomic data enriched with high-performing knowledge discovery operations and services. By doing so, it is expected that the influence of genetic variation in oncogenesis will be revealed, the molecular classification of cancer and the development of individualized therapies will be promoted, and finally, the in silico tumour growth and therapy response will be realistically and reliably modelled. Achieving these goals, ACGT will not only secure the advancement of clinico-genomic trials, but will also achieve an expandable environment to other studies’ technologies and tools. Today, it is recognized that the key to individualizing treatment for cancer lies in finding a way to quickly ‘translate’ the discoveries about human genetics made by laboratory scientists into tools that physicians can use in making decisions about the best way to treat patients. This area of medicine that links basic laboratory study to clinical data, including the treatment of patients, is called translational research and is promoted by clinico-genomic trials running in ACGT. These clinico-genomic trials are scenario based and driven by clinicians. Today, two main clinico-genomic trials and an in silico experiment are interconnected within the ACGT project. The realization of these trials will act as benchmark references for the development and assessment of the ACGT technology. All ethical and legal requirements for clinico-genomic trials will be respected. A data protection framework will be set up for ACGT, which consists of an ACGT Data Protection Board, a Trusted Third Party responsible for the pseudonymization of the patient’s data and contracts between all participating hospitals research units or other users of genetic data. Patients who take part in clinico-genomic trials may be helped personally by the treatment(s) they receive. They get up-to-date care from cancer experts, and they receive either a new treatment being tested or the best available standard treatment for their cancer. Of course, there is no guarantee that a new treatment being tested or a standard treatment will cure the patient. New treatments also may have unknown risks, but if a new treatment proves effective or more effective than standard treatment trial patients who receive it may be among the first to benefit.