New CauseHealth publication about risk assessment of drugs.

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In Bridging the Boundaries Between Scientists and Clinicians, Elena Rocca explores the field of drug risk assessment as an example of strict interdependence between basic biomedical research, clinical research, and clinical evaluation and shows how it would benefit from a closer collaboration between scientists and clinicians.

Clinicians have to report every case of side effect to the drug agencies. These data are mostly used for statistical studies, and to get an overall view of the general impact of the drug on the population. However, argues the author, such reports can serve more purposes than these.

Whenever a drug fails to give an expected effect, we should carefully analyze the “context of failure”: the patient, his physical as well as biopsychosocial condition. For this purpose, clinicians should collect as much information as possible. Why did the drug work in other patients, but not in this one? What made the difference? Such analysis might help generating mechanistic hypothesis about how the drug benefits or harms the patient. It is important, however, to understand “mechanism” in a biopsychosocial sense, rather than purely biological.

This way, an accurate clinical evaluation of the side effects and their “context of failure” could promote an advance of knowledge in basic research by providing hypotheses of causal mechanism.

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