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The accelerating pace of discovery in basic biomedical research produces an avalanche of new knowledge about the human body and its functions, from the human genome, to basic molecular and cellular processes, to the mechanisms of health and disease. There is now a myriad of discoveries of potential human benefit awaiting evaluation for efficacy and safety. Clinical research combines the discoveries from the basic science laboratory (and from socio-behavioural research) with the observations and insights of clinicians. Potential therapeutic as well as diagnostic and preventive measures are tested in preclinical settings and, as appropriate, go forward to rigorous evaluation ...