Mohan Beltangady


Phase III Failures: What Can Be Done?

September 01, 2005

Much has been written about the staggering costs of drug development and how the low Phase III success rates across the pharma industry have contributed to these costs. While safety outcomes explain many failures during the early development phase and have likewise played a prominent role in some highly publicized product withdrawals, efficacy failures in Phase III have received little attention. What we now know, however, is that a significant number of Phase III failures are attributable neither to issues of safety nor product differentiation, but to an inability to confirm efficacy against placebo.