Feature article
The data-sharing platform of the NeoBIG research program
The NeoBIG program is a research program led by Breast International Group (BIG), and aims to organize and set up next generation clinical trials in the area of breast cancer R&D. A durable, multidimensional translational research structure supporting neo-adjuvant trials is expected to be built in order to share strategies, expertise, technologies, methodologies and protocols. In addition this will provide a strong foundation for future adjuvant trials in breast cancer (and research in other cancers).
Tools and expertise developed in ACGT could be used to support NeoBIG, especially concerning the data storage, management and sharing, and with respect to privacy and security. In order to determine a possible support of the ACGT infrastructure, users requirements have been collected, scenario refined and finally the suitability of the ACGT tools and infrastructure to support the NeoBIG programme have been considered.
The NeoBIG program will include several (five currently planned) neo-adjuvant trials that will be carried out together with various Pharma companies (see figure 1). A first trial is scheduled for 2010. Each trial involves several steps from the biopsy to the surgery, leading to various types of data that should be gathered electronically. To provide a platform that enables data sharing and collaboration between cancer research centres, NeoBIG requires a robust, secure IT solution that is compliant with a wide set of regulations and laws in the context of security, safety and privacy protection. The platform needs to be able to store, manage, and share the various types of data that will be generated by NeoBIG trials.
Security is an important aspect of the NeoBIG data-sharing infrastructure. NeoBIG deals with personal data obtained from patients, whose privacy needs to be protected (both from an ethical and a legal perspective). Secondly, future prospective clinical trials with targeted therapies will require a system capable of dynamically setting up collaborations of organizations around specific data sets. Data shared within such a group needs to be well protected. Therefore, the NeoBIG data-sharing platform needs to assure secure data sharing, such as authentication of users (secure logon), authorization (access control), encryption (to guarantee confidentiality), trust establishment, and Virtual Organization Management. Additionally, the interactions with the NeoBIG data-sharing platform need to be fully audited to enable traceability. Strong requirements on the data-sharing platform are production-level reliability and availability and full maintenance. The data-sharing platform will be used and needs to be available long beyond the end of the clinical trials, as the data is highly valuable for further research.
Additionally, data interoperability and adherence to widely accepted international standards are important requirements which will enable the collaboration between BIG and other cancer organizations world-wide. In that context, well-known standards (HL7, DICOM, MIAME, MAGE, etc.) and terminologies (SNOMED, LOINC, etc.) are relevant, but also new standards emerging with the development and adoption by the US research community of relevant NeoBIG tools. As collaboration with the US cancer research community is desired and the US market is important for the pharma organizations participating in the NeoBIG trials, additional requirements need to be extracted from regulatory frameworks (such as FDA 21 CFR part 11) to which compliance needs to be assured.
A lot of ACGT expertise could be used for the NeoBIG data-sharing platform: privacy, security and data. But due to the very strict requirements for a production-level system, with available documentation and user support, commercial deployment and long-term maintenance, the current ACGT prototype tools and services cannot be directly used for the NeoBIG project, the same was preliminarily concluded about available caBIG tools and services. BIG will further make use of this investigation to refine their requirements concerning to the data sharing platform for their new research programme, to make the necessary choices and to set up a future initiative focusing on the design and development of the platform.
Figure 1: Proposed structure for the NeoBIG research program
Figure 1: Structure of the NeoBIG program