Evolving from Past to Future: Facilitating SMART research

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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