Abstract

In clinical research, there has been an increasing need to titrate ethical, legal and insurance requirements to the type of study, so that higher-risk research receives necessary and appropriate detailed attention, 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 patients. This type of investigation, however, is currently hampered by the fact that, in many hospitals and jurisdictions it has to undergo the same bureaucratic procedures and safety assessments as high-risk, for-profit studies. We strongly believe that such practice of scientific research assessment 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 addition, 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, scientists, patients, patient associations, politicians, scientific associations and common citizens should be involved in this process, as they all play a crucial role in its evolution and success.

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

Key-words: no profit study, medical research, ethical committee, progress

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