Senior Scientist Professional Health Solutions & Services, Mathematics & Informatics, Information Architectures, Translational Research IT, Data Analytics.
Title: Managing a global tranSMART-based active surveillance (prostate cancer) database: the Movember GAP3 project
The Movember Global Action Plan 3 (GAP3) on Active Surveillance of men with localized low-risk prostate cancer includes the construction and management of a sustainable worldwide database for clinical, marker-related, and imaging data for scientific analyses and improvement of guidelines (GAP3 Database). Active Surveillance data of over 14000 patients from 24 institutes worldwide has been integrated and loaded in the tranSMART-based GAP3 database.
Movember GAP3 aims at:
– creating a global consensus on the selection and monitoring protocol of men with low risk prostate cancer;
– managing a worldwide platform with information and guidelines on Active Surveillance as acknowledged treatment option for prostate cancer;
– reducing the number of men switching towards active therapy within one year after start of the Active Surveillance protocol.
The GAP3 IT infrastructure is based on the prostate cancer instance of the tranSMART-based TraIT IT infrastructure developed by Philips within the Dutch TraIT and PCMM projects (www.ctmm-trait.nl, www.ctmm.nl/en/projecten/kanker/pcmm). This infrastructure is setup to meet the security and privacy requirements of the multi-site GAP3 project. It offers support for the regular collection, validation, curation and integration of various longitudinal datasets from the participating institutes into the GAP3 database. The statisticians in the project are provided a secure, R-based statistical analysis environment with support to easily connect to the GAP3 database. The technical challenges are, amongst others, the secure management of regularly updated, multi-site study data while safeguarding the quality of the research data to allow proper statistical analyses. We will report on the challenges that have been addressed, while meeting the needs of a global consortium, and the extensions and adaptations that were and are needed in the tranSMART-based infrastructure, more specifically the need for a solution to support the management of longitudinal study data across multiple studies more fundamentally.