RCTs in psychiatry: challenges and the future.

The editor of the Lancet, Richard Horton, an articulate critic of much of modern medicine, gave a keynote address at the 2001 Society for Clinical Trials annual meeting, provocatively entitled, "The clinical trial: deceitful, disputable, unbelievable, unhelpful, and shameful-what next?" Horton (2001) suggests that the clinical trial process is approaching a critical moment, with growing public scepticism already producing problems in patient recruitment for some trial organizers. Failure to recruit adequate patient numbers is a real threat to many trials and often the reason that an unknown number of trials get abandoned and left unreported. In this editorial we expand on the themes that one of us raised in a recent book (Everitt & Wessely, 2003) and look to the future and consider how the situation might be improved.