Everyone talks about the need to do trials differently but very few actually achieve it. Unless, of course, it is to make things more intricate and expensive! Against a background of spiralling costs, struggling recruitment and every increasing complexity, the recently reported TASTE trial was a breath of fresh air. For those of you that didn’t spot this study published in the New England Journal of Medicine a couple of months ago, it was a large-scale randomised trial examining the effect of thrombus aspiration in acute myocardial infraction. Needless to say the neutral trial result wasn’t the headline, with all-cause mortality and a string of secondary outcomes unchanged by the intervention.
The real interest was in the way that the trial was done, and the incredibly low cost it was achieved at – by piggybacking on the Swedish registry system this study was reported by one commentator to have cost just $300,000 in incremental expenditure. Not bad for a 7,000 patient study. As an academic researcher based at the George Institute for Global Health in Sydney this really got me interested. I’m used to stretching limited resources. And over the years have been involved in a number of ‘’large-simple trials’’ evaluating cardiovascular outcomes. But this sort of economy sets a new benchmark for us all.
In addition to my George Institute role, I am also the Scientific Director of George Clinical, a Contract Research Organisation wholly owned by the Institute. Our point of difference from the traditional CRO model derives from our scientific and operational leadership. The goal of George Clinicalis to provide clinical research services to the pharmaceutical industry but to do it in a way that the traditional CRO can’t. At George Clinical, we leverage academic expertise to develop and incorporate innovations like those in TASTE, while maintaining the operational excellence expected by industry.
While George Clinical is willing to provide just the usual fee for service functions that a traditional CRO provides, it is the integration of the academics that makes us different. By leveraging the skills, insights and connections of our researchers, we bring dimensions that can translate to both time and cost savings for our customers. For now, perhaps not a 7000 patient trial for $300,000! But clever design, streamlined operations and efficient analyses on a lesser scale can still make a world of difference.
My role spanning George Clinical and George Institute is to provide scientific leadership to studies in my therapeutic areas but also to drive innovations in methodology. Diabetes is a primary focus at the moment and builds upon our ADVANCE trial experience. We completed ADVANCE some years ago but as one of the first large scale outcome trials in diabetes it cemented our role as a leader in the field. Having randomised more than 11,000 patients into ADVANCE we have been able to work with sponsors to offer global reach and extensive content area expertise. This has resulted in scientific and leadership roles in three more large diabetes trials since, with several others now in the pipeline. The Asia-Pacific has been a particular asset for us because of our operational bases in the region, but also because of our strong academic linkages to the key opinion leaders and their networks.
Two fields of methodology we are currently working on are endpoint adjudication and trial monitoring. In both we have identified significant opportunities for centralization and simplification of trial processes. Already we are rolling out these new methodologies in our academic research program. Persuading our commercial customers to take up these opportunities in full is going to take a while longer, but already we are starting to see this trickle down. As with so much in health research, there’s not going to be a magic bullet and things aren’t going to change overnight. But it’s not going to stand still either and our goal at George Clinical is to make sure we are at the front of the pack.
To learn more about how you can do things differently in your clinical trials register for our upcoming webinar on the 19th February here