Evolving from Past to Future: Facilitating SMART research
Author(s) -
Marina Pieri,
Rinaldo Bellomo,
Alberto Zangrillo,
Dario Winterton,
Giovanni Landoni
Publication year - 2016
Publication title -
signa vitae
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.141
H-Index - 7
eISSN - 1845-206X
pISSN - 1334-5605
DOI - 10.22514/sv121.092016.1
Subject(s) - bureaucracy , medicine , profit (economics) , clinical practice , health care , order (exchange) , engineering ethics , risk analysis (engineering) , business , political science , nursing , law , finance , politics , economics , microeconomics , engineering
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.
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