Knowledge of the rates and causes of drug candidate attrition by clinical development phase and by therapeutic area is valuable in assessing the impact of changes in development strategy and research area focus by the pharmaceutical industry. Two years ago, we published brief reports on failures in Phase III and submission from 2007 to 2010 (Nature Rev. Drug Discov. 10, 87; 2011) and failures in Phase II from 2008 to 2010 (Nature Rev. Drug Discov. 10, 328–329; 2011). Here, using data gathered from Drugs of Today, as in the previous analyses, we have conducted a similar analysis for 2011 and 2012.

When looked at by phase, for the most recent year range, the proportion of failures due to lack of efficacy was higher in Phase II (59%), but still disturbingly high in Phase III and beyond (52%). The proportion of failures due to safety issues is higher in Phase III and beyond compared with Phase II — at 35% and 22%, respectively — which may be due to safety issues that only become apparent in larger numbers of patients and/or longer trials.

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