ACGT links to the new EU funded projects: ENCCA and CONTRACT
The necessity of an environment that deals with the recent advances in high throughput genomics and post-genomics methods and technologies in molecular biology, which have resulted in an explosion of information and knowledge about cancer and its treatment, is more than evident today. As a result of this explosion in information and knowledge, our ability to characterize and understand the various forms of cancer is growing exponentially. Information arising from post-genomics research and combined genetic and clinical trials on one hand, and advances from high-performance computing and informatics on the other is rapidly providing the medical and scientific community with an enormous opportunity to improve prognosis of patients with cancer by individualizing treatment. Multi-level data collection within clinico-genomic trials and interdisciplinary analysis by clinicians, molecular biologists and others involved in life science is mandatory to further improve the outcome of cancer patients. It is essential to merge the research results of biomolecular findings, imaging studies and clinical data of patients and to enable users to easily join, analyze and share even great amounts of data.
The vision of the European Network for Cancer Research in Children and Adolescents (ENCCA) funded by the European Commission as a Network of Excellence (NoE) is to establish a durable, integrated clinical and translational research infrastructure for Europe that will define and implement its research strategy and will facilitate the necessary investigator-driven clinical trials to introduce the new generation of biologically targeted drugs into standard of care for children and adolescents with cancer. As the goal of ACGT is to develop an open-source and open access IT infrastructure that provides the biomedical research community with the tools needed to integrate complex and heterogeneous data from clinical information systems, from molecular biology (post-genomic data), from imaging studies (DICOM data), and from the Web in a standardized way FORTH as the scientific coordinator of ACGT was asked to participate in the NoE as a funded member of the consortium. USAAR as a partner in ACGT is a non-funded member of ENCCA. The ENCCA NoE brings together internationally recognised Paediatric Oncology AcademicInstitutions and many associated organisations that aim to integrate the existing Clinical Trials Groups in Paediatric and Adolescent Oncology towards a EuropeanVirtual Institute to reduce knowledge fragmentation and enhance their communication, collaboration and management of effective clinical research in Europe. The objective is to structure knowledge-sharing through the integration of the whole chain of stakeholders (epidemiologists, imaging developers, biologists, clinicians, drug developers, industrials, parent and patient groups, ethical, IT and regulatory authorities). This will support the development of specific therapeutic strategies relevant for tumours in children and adolescents and should accelerate the development of targeted compounds for cancers in this age group. The contribution of ACGT in this NoE will be in helping to establish an integrated ICT infrastructure for Paediatric Oncology in Europe. Specifically FORTH will lead a task dealing with the analysis of existing ICT systems and solutions for patient administration and clinical data management and together with USAAR FORTH is enrolled to implementa Web-based integrated data collection tool for studies on Wilms tumour patients as a proof of principle for other prospective data collections and clinical trials. In this task ObTiMA will be piloted for data management on patients registered in the current SIOP WT 2001 trial and study. A database for the logistics of bio-banking of Wilms tumour material throughout Europe will be defined to test the decentralised storage of Wilms tumour biomaterial. The ACGT workflow enactor will be used to develop workflows for the analysis of molecular biological data derived from these Wilms tumours by the seamless integration of clinical, imaging data and web based data in a standardised way to define new risk factors for the stratification of Wilms tumour patients. During the life time of the project the ACGT Master Ontology will be evaluated and enhanced for Paediatric Oncology. In addition a DICOM-server and a system for international central imaging review will be build. It has to be stressed that a prospective collection of clinical, imaging and postgenomic data needs a legal framework. This is especially true as these data are used by many different and sometimes multi-role end-users. Within the NoE the legal framework of ACGT will be tested based on contracts with hospitals, informed consents with patients, and IT tools for data security.
CONTRACT’s acronym stands for “Consent in a Trial and Care Environment” and consent will be the main focus of the project. The Consortium - involving five partners from universities, research institutions and SMEs of which three belong to the ACGT project, namely, LUH (project coordinator), USAAR and Custodix,will focus on analyzing how the legal concepts of informed consent in the European Data Protection Directive and in the ClinicalTrials Directive differ from each other and from the different regulations of informed consent for care in chosen Member States of European Union. The project will analyse the consent issues in vulnerable patient groups, with the paediatric population in the central point as the requirements are of the most demanding complexity there.
The outcome should be an assessment how far those different understandings of informed consent have an impact on the success of translational research. The concept will be analyzed from a legal, ethical, IT-related and clinical point of view. The Consortium will use the outcomes of their own research in the ACGT project[1]
CONTRACT will support translational research projects – both ongoing and upcoming. It will develop a multidisciplinary approach in delivering facts and figures on different approaches to informed consent both in European projects and in European Member States. CONTRACT will analyze the IT-related representation of these different understandings and the outcome of these differences in the daily clinical and/or research routine. To achieve this the consortium will circulate a questionnaire directed to the partner projects which are, or were working with vulnerable patients. In those questionnaires the questions about legal and ethical, security and clinical practices will find their place.
CONTRACT will in further steps advise translational research projects in all issues of informed consent and will deliver concrete policy recommendations as to how the European Union could jointly protect patient’s rights and support translational research by a better structured approach towards consent issues.
At helpdesk will be established that it will offer advice to projects on all possible issues of informed consent. The helpdesk will offer a data-protection-framework ready to run and will provide a help forum for legal, ethical, IT-related and clinical questions related to informed consent and data protection in translational research
Finally the project results will be disseminated at two stakeholder workshops to be held in month 12 and 24 of the project. These will provide an ideal forum for European policy makers and researchers to exchange views on the project’s results and possible options for future policies in this area.
Nikolaus FORGO-LUH / Manolis TSIKNAKIS-FORTH