Through 3 years of experience managing a busy trial site, one of the most apparent characteristics in the industry that I have noted is the surprisingly significant lack of quality private clinical trial sites in Australia. I mean this as no offence and of course there are great sites out there, although we need only look at staffing, infrastructure and experience inadequacies to know that this is clear, if we also consider the dearth of fundamental business management proficiency, such as marketing, financial and quality management, it soon becomes apparent why so many sites struggle to develop, and why research can be an unattractive option for prospective physicians.
The balance of the clinical research industry in Australia presents a major concern for a wholly self-sufficient, private clinical trial site and is a constant barrier to site development advocacy. The relationship between research stakeholders (Sponsors, CRO’s and Sites) is very traditional, at times outdated and almost always biased. There is a paradoxical approach which sees sponsors and CRO’s constantly searching for quality research sites with dedicated staff and comprehensive facilities, although conversely, in a business sense, it seems the industry largely hopes for docility from sites, they require specialist clinical management of trials but it does not work in the ‘payers’ interest for sites to be financially aware, or to be unique from other sites, or to use evidence-based research to form reliable business propositions. No, instead there is a push be uniform, regardless of your business structure, appreciative of the offer of the trial in the first place, be as passive as possible through the negotiation period and accept the proposed budget or you won’t get the next study. Your hands are tied from the start and the standard process is perpetuated and we go round and round. Championing site sustainability and development means challenging long standing views and forever fighting an uphill battle to convince both Sponsors and CRO’s, that we are a business too, just like you.
My view for quite some time has been that the standard of research sites needs to rise holistically to be a legitimate and appropriately respected stakeholder in the clinical research process. If standard Quality Management Benchmarks existed for Clinical Trial Site business management, to compliment the specialist medical and clinical skills we already have, yes, sites may get paid more, but consequently sites would be better resourced, employment would be both more attractive and viable, trials would recruit faster, data integrity would be further protected and endpoints would be met more efficiently. As sites further enhance their sustainability, there are prospectively more options for Sponsors and CRO’s and Australia itself becomes more attractive as a research destination. It may be naive but everyone wins right?
As a site, there comes a point where you have to stop being apathetic, you are forced to become aware of these true risks to business and the inherent naivety in the thought that the industry will change for us. It’s not going to happen; we have to force the change. To relegate our commercial dependence on traditional stakeholders there must be deliberate, conscientious and systematic action for your business to fulfil its potential. Until you have a competitive advantage, you cannot compete.
Chief Executive Officer
Genesis Research Services Pty Limited