Optimising cohort data in Europe

and harmonisation of data. To start, there are practical challenges as harmonising data across studies can be complex, and time and resource consuming. There are substantial administrative challenges, such as identifying the studies, getting access to the individual participant level data and addressing ethical and legal issues. Additionally, there are the methodological challenges in integrating highly heterogeneous data from widely diverse cohort populations that have not been designed ex ante to collect identical information. The point is that Europe is extremely well-served by a rich variety of population, patient and clinical trial cohorts, but that the enormous potential benefits of this rich information still remain not fully and optimally exploited. This is the reason why SYNCHROS set itself the challenge of defining a European/international approach for the optimisation of cohort data. In collaboration with a broad spectrum of stakeholders (e.g. principal investigators of large cohort studies, coordinators of harmonisation initiatives, representatives of ethics committees, data managers, legal advisers, policy-makers or representatives of funding agencies), SYNCHROS defined a strategy towards the integration of European and international health cohorts. 2. Objectives The main objective of the SYNCHROS project was to establish a sustainable European strategy for the development of the next generation of integrated cohorts, thereby contributing to an international strategic agenda for enhanced coordination of cohorts globally, in order to address practical, ethical, legal and methodological challenges to optimising the exploitation of current and future cohort data, towards the development of stratified and personalised medicine as well as facilitating health care policies. y y To map the cohort landscape in Europe and large international initiatives. y y To identify the best methods for integrating cohort data in order to enable the harmonisation of past ( ex ante harmonisation) and future ( ex post harmonisation) data collection. y y To identify solutions for addressing practical, ethical and legal challenges in integrating data across patients, clinical trials and population cohorts. y y To take stock of emerging and new data collection technologies and types of data, including new exposures and health risks, and their potential impact on the development of future cohort studies and the need to optimise the integration of data. Some of the more specific objectives of SYNCHROS included the following: