Journal Article

Managerial Framework for a large Multi-centre Clinical Trial within an EU-funded Collaborative Project - the \PREVIEW\ Case Study

Pastor-Sanz, Laura, Raben, Anne, Brand-Miller, Jennie, Feskens, Edith, Westerterp-Plantenga, Margriet, Schlicht, Wolfgang, Fogelholm, Michael

2021

Overview

A multi-centre clinical trial involves the implementation of the same clinical protocol at several independent investigational centres. Multi-centre clinical trials may be preferable to single-centre trials, but their implementation and management is more complex. EU-funded collaborative projects involve several participating organizations and countries and their consortia are typically multidisciplinary. Their coordination requires a joint effort from several actors, and an appropriate managerial structure and procedures need to be defined and established. The management of the Framework Programme 7 (FP7) PREVIEW project, whose core consisted of a clinical trial with 8 intervention centres/sites is presented as case study. PREVIEW was coordinated by the University of Copenhagen. The project management was implemented by a combination of decentralised project management, at the department level, jointly by the Project Coordinator (PC) and Project Manager (PM), and centralised, by a dedicated EU Liaison Officer from the Project Management Office (PMO). The Quality Manager role was undertaken by the PC, with support from selected consortium members. The Exploitation Manager role was assumed by the leader of the dissemination and exploitation work package. The Data Manager (DM) at the University of Copenhagen established and maintained a datahub for all data from the clinical trial. The General Assembly and Steering Committee were key decision bodies with regard to taking and implementing decisions. The Scientific Advisory Board (SAB) was formed by reputed external experts providing guidance and advice. The project website was the main channel to reach the general public. A password protected private section was used as internal repository for the project. Regular meetings at all levels were key to ensure good communication and collaboration among the project team. Appropriate attention to data management was given from the start. The privacy of personal data was ensured in accordance with national and EU regulations. The PC was also the Sponsor of the multicentre clinical trial, and the PM served as the overall Clinical Trial Administrator. Each centre was led by a Principal Investigator (PI), running the trial together with the local daily responsible. The tasks and responsibilities for the clinical trial of the Coordinating Centre were shared between Copenhagen and Helsinki centres. The trial was overall led by the Clinical Trial Manager (CTM), who was the PI at the Helsinki centre. The local Independent Ethical Committees approved the protocol prior to the start of the intervention. One member of the SAB acted as Ethical Officer. The trial/study had an overall statistician. The Analyst role was shared among different people from the Copenhagen and Helsinki centres. The DM created and maintained database for the intervention and the Clinical Report Forms by using OpenClinica open source software. The staff in the intervention received training in Good Clinical Practices, the protocol and its procedures. The monitoring tasks were jointly undertaken by the Sponsor and the CTM. The documents from the Trial Master File were saved in the Internal Repository. A set of Standard Operation Procedures was defined. Meetings among all Pis, and within the Instructors' Network were key in the success of the intervention. This case study aims at serving as guidance to coordinating researchers, both duringthe proposal preparation and project implementation phases, as well as to provide visibility and insight into the multi-faceted role of the project managers and administrators of such projects.

• Publisher: Society of Research Administrators, Inc,Society of Research Administrators,Society of Research Administrators International
• Subject: Administrative Organization / Case studies / Clinical trials / Collaboration / Communication / Communication (Thought Transfer) / Computer simulation / Consortia / Coordination / Coordinators / Cultural Differences / Diabetes / Ethics / Evaluation / Foreign Countries / Governance / Guidance / Information accessibility / Information management / Institutional Cooperation / Intervention / Leadership / Leadership Styles / Managers / Medical Research / Methods / Money Management / Project management / R&D / Research & development / Research Administration / Research and Development / Research Projects / Research Tools / Researchers / Writing Instruction / Writing Processes