November 12th 2024
Results from survey of 100 site personnel suggest a disconnect is present between these stakeholders.
Phase III Failures: What Can Be Done?
September 1st 2005Much 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.
Successful Outsourcing: Tracking the Evolving Use of Full-Service and Niche-Service CROs
June 1st 2005Following more than two decades of growing involvement in nearly all aspects of drug development, full-service and niche-services contract research organizations (CROs) have become a common and integral part of most sponsor companies' clinical research teams.