The randomized controlled trial (RCT) is arguably statistics’ greatest gift to medicine. Over half a century of trials have seen many advances in their design, conduct and reporting. All aspects of trials are becoming ever more regulated, most of which is highly beneficial. However, increasingly, one sees proposals for ‘CONSORT compliant’ trials! Simplistic prescription promotes the idea and practice that doing an RCT is simply a matter of adopting routine approaches to the design and conduct of trials, ticking boxes and reaping the evidence. Focusing on pro forma requirements over the life of a trial risks diverting attention from optimizing the design of individual trials and curtails discussion of broader issues concerning the way we conduct them and the nature of the evidence they yield.
This talk is a sampler—a personal, incomplete and undoubtedly idiosyncratic one—of issues that are germane to the current conduct of trials, with particular focus on those conducted outside the realm of pharmaceutical regulation agencies, i.e., psychotherapeutic, behavioural and public health interventions.
Andrew Mackinnon completed a typically forgettable PhD in experimental psychology in the 1980s. After a brief postdoc in Switzerland he was forced to choose between a tenured lectureship (with excellent surfing opportunities) at the University of Wollongong and a short term research fellowship at the ANU. Consequently, he learnt most of what he knows about mental health research on the shores of Lake Burley Griffin at the predecessor of the ANU’s Centre for Mental Health Research. He subsequently worked as Deputy Director of the Mental Health Research Institute of Victoria and returned the Centre for Mental Health Research as Deputy Director between 2005 and 2008. Currently he works at the Black Dog Institute in Sydney and Centre for Mental Health at the University of Melbourne.
Andrew’s work spans a wide range of epidemiological surveys, the development screening and measurement instruments and a large portfolio of randomised controlled trials. He is a prolific calculator and, as a result, his name appears in the ‘et al.’ section of many papers. His current DPI (Dud Paper Index) is 7. He has lost endless summers applying for hundreds of millions of dollars of research funding, mostly unsuccessfully (which, in many cases, may have been the best outcome).