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The label academic research organization (ARO), used broadly within the clinical and drug development industries, primarily refers to an academic and/or nonprofit institution that performs one or more functions in the conduct of clinical trials. The services that an ARO provides can range from academic leadership to full-service clinical trial management capabilities, including site monitoring, data management, statistical analysis, safety monitoring, and clinical events classification, in addition to clinical expertise.

The concept of an ARO dates back several decades, when researchers recognized the need for large global clinical trials to answer important medical questions. Clinical scientists from several of the world's leading academic institutions formed teams of like-minded investigators with the goal of developing and conducting global clinical studies to improve patient care. AROs are focused on developing and sharing knowledge with the end goal of improving patient care. They accomplish this goal not only by leading and conducting multinational clinical trials but also by ensuring that the results from these trials are published and presented. These groups also focus on managing major national patient registries designed to collect data and determine best practices, which can then be incorporated into clinical practice guidelines. Education and development of clinical investigators is also a focus, with many of the leading AROs having fellowship programs whose influence extends around the globe.

The concept of the ARO dates back to the late 1980s, when several groups of physician investigators first came together to address unmet clinical needs by organizing and centralizing the operational efforts associated with conducting large multicenter clinical trials, so-called “megatrials.” The first such group, located at the University of Oxford in the United Kingdom, developed in 1975 from a single research team. It began enrollment of the then-largest trial in history—6,027 patients with suspected acute myocardial infarction (MI)—in mid-1981, completed enrollment at the 245 participating coronary care units in 1985, and published the results the next year (1). Similarly, the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico (GISSI), formed from a collaboration between the Mario Negri Institute and the Associazione Nazionale dei Medici Cardiologi Ospedalieri, began enrolling 11,806 patients with acute MI in 176 Italian intensive care units in 1984. It published the study results 2 years later (2). Both groups have since continued to perform large, important multicenter trials.

Two groups in particular have paved the way for what we now know as AROs. The Thrombolysis In Myocardial Infarction (TIMI) study group, based in Boston, Massachusetts, and affiliated with Brigham and Women's Hospital and Harvard Medical School, was among the first groups to take on the challenges associated with organizing and implementing global clinical trials (3). The TIMI series of trials began in 1984, initially sponsored by the National Heart, Lung, and Blood Institute (NHLBI). At first, the trials studied thrombolytic and antithrombotic therapies in patients with acute MI and unstable angina, but they now cover many aspects of cardiovascular ...

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