Editors' pick 2010

Risk/safety assessment

One of the recurring themes in this year's BJCP is the assessment of risk. The adage that ‘every drug is a poison’ should be foremost in the minds of every prescriber, or clinical research physician, but at what point does one call a halt to proceedings and declare that the harms outweigh any potential benefit? Sibille and colleagues at the French Club Phase I point out the lack of any consistent stopping rules in early phase studies, and the difficulties in applying toxicity grading systems from phase I/II/III cancer chemotherapy trials to studies in healthy volunteers [1]. Phase I participants clearly start at different baseline health levels, and have much less to gain (usually only a modest financial reward), as compared with cancer patients seeking a life-saving cure. Sibille et al. have started the ball rolling with their ‘points to consider’ in the development of safety stopping rules for phase I trials in healthy volunteers. These early proposals are by no means definitive, but will hopefully stimulate debate perhaps leading to some agreement on deciding at what point the ‘fat lady begins to sing’.