SECURE Work plan

In SECURE the management tasks will be shared between two partners:

• CNIC, a renowned Spanish research institution, recognised for their expertise in the targeted research field has been welcomed by the partners as project coordinator. CNIC will ensure the strategic management of the consortium through the coordination of scientific and innovation activities.
• ARTTIC, an SME specialised in the management of large international RTD collaborations since 26 years, will ensure the day-to-day operational project management and provide the consortium with its project management experience, methods and tools for the follow-up of financial, contractual and administrative issues.

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:

• Participation to targeted international conferences through poster and podium presentations
• Scientific articles to be published in specialised peer-reviewed scientific journals
• Cooperation with other projects in the field
• Exchanges with standardisation committees
• Communication via the public website
• Preparation of common press releases at major milestone dates of the project
• Presentation of final results during the Congress of the European Society of Cardiology

WP3 has the following objectives:

• To translate, prepare and adapt protocol and ancillary documentation to national (local) regulations and GCP guidelines.
• To select sites and investigators according to study requirements.
• To prepare submission forms to Ethics Committees and/or Competent Authorities for study approvals and/or authorisations.
• To boost pre-study bureaucratic procedures at different clinical sites in order to obtain final agreement.
• To provide study-related training to investigators and collaborators.
• To prepare investigator’s files with essential documents according to GCP guidelines.

This work package will consist in the following activities:

• Production of the CV FDC pill (ASR 2,5 –ASR 5- ASR-10)
• Packaging, labelling of the FDC pill
• Packaging design consultation (kits & labels design & translation)
• Patient kit production and shipment
• Management of the clinical trial medication from the beginning until the end of the study: reception storage & distribution of study drug to sites, stock control, return and reconciliation of used medication and destruction of all samples at the end of the study

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.