In SECURE the management tasks will be shared between two partners:
The objective of this Work Package is to create awareness of the project development to key stakeholders, on the one hand, and to ensure a wide and targeted dissemination of the knowledge generated by the SECURE project, on the other hand.
Dissemination will notably consist of the following activities:
WP3 has the following objectives:
This work package will consist in the following activities:
WP5 consists in a randomised, two-arm, parallel trial. Those patients that fulfil the inclusion/exclusion criteria as defined by the study protocol will be invited to enter Study. Patients entering this step (3200 patients at 85 sites) will be randomized to one of two arms: FDC pill or standard care. Randomization will take place within each country to ensure comparability.
Main activities in this WP will include the identification and randomization of patients, obtaining clinical data, patients follow-up, MACE (Major adverse CV events) measurement, adherence, quality of life & pharmacoeconomics data. Meticulous monitoring of all these activities is critical for the project success. To this end, regular monitoring visits will be undertaken, aimed at verifying that the rights and well-being of the participating human subjects are protected under GCP. Moreover, it will be verified that the trial data as reported by the participants are accurate, complete and verifiable form the source documents, and that the overall conduct of the trial is in compliance with the approved protocols and the applicable regulatory requirements. At conclusion of the monitoring visits, the monitor reviews the findings with the coordinator. If necessary, corrective actions may need to be implemented.
All data that have been collected during the study in specifically designed forms will be entered into and tracked by a secure central web-based electronic data capture and data management system located at CNIC. Data entry can be performed from any computer with Internet access. Data privacy and protection will be guaranteed by keeping patients’ identification in a completely separated and password-protected data base at each site in accordance with the regulatory requirements. Work package leader CNIC will be responsible for the maintenance of the central data base.
The complete statistical section including statistical methods for the main analyses and the analysis of all variables, the handling of missing data, the study populations and other details will be specified and fully detailed in the Statistical Analysis Plan (SAP) that will form part of the final clinical protocol.