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Evolving from Past to Future: Facilitating SMART research


1Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute

2Faculty of Medicine, University of Melbourne, Melbourne, VIC, Australia

3Vita-Salute San Raffaele University, Milan, Italy

DOI: 10.22514/SV121.092016.1 Vol.12,Issue S1,October 2016 pp.14-18

Published: 10 October 2016

*Corresponding Author(s): GIOVANNI LANDONI E-mail:


In clinical research, there has been an in-creasing need to titrate ethical, legal and insurance requirements to the type of study, so that higher-risk research receives necessary and appropriate detailed atten-tion, while low-risk studies can proceed more rapidly.

Spontaneous Medically Advantageous Research Trials (SMART) are non-profit studies that carry minimal or no risk to pa-tients. This type of investigation, however, is currently hampered by the fact that, in many hospitals and jurisdictions it has to undergo the same bureaucratic proce-dures and safety assessments as high-risk, for-profit studies. We strongly believe that such practice of scientific research assess-ment should be radically modified. We advocate a new, specific research category for SMART investigations that grants them a preferential route from conception to ethics assessment to execution. In addi-tion, we argue that such low risk studies assessing common, often not evidence-based applied treatments or investigations should in fact be a mandatory component of modern medicine. All clinicians, scien-tists, patients, patient associations, politi-cians, scientific associations and common citizens should be involved in this process, as they all play a crucial role in its evolu-tion and success.

We contend that modern medical research and entire health systems should transi-tion to a novel model of healthcare system where SMART execution is embedded into daily practice, in order to minimize anec-dotal practice and maximize evidence-based practice.


no profit study, medical re-search, ethical committee, progress

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MARINA PIERI,RINALDO BELLOMO,ALBERTO ZANGRILLO,DARIO WINTERTON,GIOVANNI LANDONI. Evolving from Past to Future: Facilitating SMART research. Signa Vitae. 2016. 12(S1);14-18.


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