The extensive global reach of Julius Clinical is demonstrated well by the ALECARDIO trial. The aim of the trial was to determine the effect of treatment with aleglitazar on cardiovascular mortality and morbidity (defined as non-fatal myocardial infarction or stroke) in patients with type 2 diabetes who experienced a recent acute coronary syndrome (ACS) event.
Overall, about 7,000 patients were recruited at 705 sites in 26 countries in Europe, Northern America, Latin America, Asia Pacific, and Australia/New Zealand. Julius Clinical and its network of local partners were responsible for recruiting most of the patients required for the study.
PROJECT MANAGEMENT
In this study, Julius Clinical’s Project Director was overall responsible for the project execution (timelines, budget, scope and quality) with a specific focus on planning and management based on metrics. Our training department was responsible for the overview, execution and revision of the training plan and provided the training for the assigned Lead CRAs and PMs.
DATA MANAGEMENT
Data Management for the Alecardio project was being carried out by teams from the Data Management departments of Julius Clinical (Zeist, The Netherlands), The George Institute for Global Health (Sydney, Australia) and Julius Center for Health Sciences and Primary Care (Utrecht, The Netherlands). This allowed for global coverage for all activities, as well as flexibility.
The Alecardio Data Management team was involved in the following activities:
SITE MANAGEMENT AND MONITORING
For this study Julius Clinical and its network of local partners managed sites in the European Union, Brazil, Argentina, Mexico, Korea and Thailand. Our GACCT partners manage the sites in the other countries, such as the United States. 80% of the patients recruited for this study were included under the direction Julius Clinical.
ENDPOINT ADJUDICATION
Julius Clinical reports occurrence of study endpoints within one working day. This triggers the adjudication process. All appropriate source documents and CRF information will be assembled and forwarded to the CEC for adjudication. Any possible endpoint forwarded to the CEC will be adjudicated based on pre-specified definitions. Julius Clinical provides the definitions of the endpoints as well as further detail on adjudication procedures.
PHARMACOVIGILANCE
Our Safety Team processes Serious Adverse Events (SAEs) and pregnancies within the timelines as required by the regulatory requirements for safety reporting. They also raise (urgent) safety queries in the electronic Clinical Study Database and follow-up until they have been answered by the Investigator. This team also is responsible for Expedited Safety Reporting, SSR- and DSUR reporting to the participating investigators. For Alecardio, Julius Clinical developed and implemented an Unblinded Distribution process for unblinded expedited safety reporting to Ethics Committees and/or Health Authorities.
Effect of aleglitazar on cardiovascular outcomes after acute coronary syndrome in patients with type 2 diabetes mellitus: the AleCardio randomized clinical trial.
Lincoff AM, Tardif JC, Schwartz GG, Nicholls SJ, Rydén L, Neal B, Malmberg K, Wedel H, Buse JB, Henry RR, Weichert A, Cannata R, Svensson A, Volz D, Grobbee DE; AleCardio Investigators.
JAMA. 2014 Apr 16;311(15):1515-25. doi: 10.1001/jama.2014.3321. PubMed PMID: 24682069
Evaluation of the dual peroxisome proliferator-activated receptor α/γ agonist aleglitazar to reduce cardiovascular events in patients with acute coronary syndrome and type 2 diabetes mellitus: rationale and design of the AleCardio trial.
Evaluation of the dual peroxisome proliferator-activated receptor α/γ agonist aleglitazar to reduce cardiovascular events in patients with acute coronary syndrome and type 2 diabetes mellitus: rationale and design of the AleCardio trial.
Lincoff AM, Tardif JC, Neal B, Nicholls SJ, Rydén L, Schwartz GG, Malmberg K, Buse JB, Henry RR, Wedel H, Weichert A, Cannata R, Grobbee DE.
Am Heart J. 2013 Sep;166(3):429-34. doi: 10.1016/j.ahj.2013.05.013. Epub 2013 Jul 26. PubMed PMID: 24016490
