It’s something of a paradox that while sponsors are trying to accelerate progress by taking on more clinical study sites for their trial, they do tend to select only those that perform the best.
The reality though is that in this day of larger, multi-site complex trials, many studies will have just a small proportion of highly experienced, high performing sites. The ability to transform novice sites into successful ones will be key to greater productivity and efficiency.
So, what makes the difference between a successful and poor study site?
The Site Team
It’s been said that the secret formula to being the best clinical trial site is “empowerment”. And it’s certainly true that, when it comes to study performance, working in partnership and giving ownership to the site study team is essential.
Establishing an equal and efficient dialogue, equipping staff to do a great job, and then rewarding them for success in hitting their milestones: all these measures serve to boost engagement, not just at individual sites but across the entire trial. After all, why would you continue to run trials if you’ve had a less than positive experience and have no idea whether or not your efforts have been valuable, or even appreciated?
Some success has been had from adopting a ‘gaming’ approach to site team engagement – thinking about the kind of rewards or milestones that will motivate site teams to do ‘even better’. Many sponsors have established friendly competitions among sites to inspire recruitment efforts to hit key milestones, or to encourage study teams to actively participate in awareness days and promotional campaigns. Not only does this build a sense of team across the trial, it has knock-on effects for patient engagement also. They observe a slick, seamless operation, with study teams who clearly care about their condition.
The sponsor’s role in establishing a positive, empowering, and motivating culture for study teams cannot be underestimated. High-functioning trial sites are those that take ownership over their compliance, and commit to the requirements needed to deliver high caliber clinical research data. In order to do this, however, they must be empowered and equipped for success.
Indeed, in a project to identify the key drivers of study start-up performance, adhering to operational and recruiting timelines, aligning the study personnel with the proposal, and project manager performance were the factors most significantly linked to site success. Those sites that are first to randomize a patient into the study also tend to perform better overall.
Research increasingly shows that sponsors and CROs can improve site performance by providing clear, consistent protocols, ideally developed in partnership. At Longboat, we’ve heard from our focus groups with clinical sites that there is a real need for a clear, easy-to-understand, list of instructions for each visit and each procedure.
Unfortunately, this isn’t yet a common occurrence in real-world trial management. However, research by Tufts on protocol design complexity does suggest that streamlined and simplified protocols, designed with input from study coordinators and investigators, presents a major opportunity for sponsors to improve site performance.
Protocol amendments also have a detrimental effect on site performance in terms of protocol compliance. For this reason, some pharma companies now include the number of protocol amendments as a key performance evaluation criteria. The fewer protocol amendments, the better site performance becomes. Of course protocol amendments are frequently unavoidable, and in these case the expedient delivery of communication and re-education to sites is critical.
According to Christine Pierre, Founder and President of The Society for Clinical Research Sites (SCRS), “a good site invests in quality systems to deliver quality data for the ultimate outcome of safe and effective new medical therapies reaching the patients waiting for them”.
For the current generation of clinical investigators, this is likely to appear quite different to the systems used in the past. These teams are likely to recoil in horror at the antiquated paper processes still perpetuated in clinical trial coordination. In order to engage these new recruits to run clinical trials not once, but repeatedly, the support tools and communication channels need to be tailored to this new tech-savvy audience.
Systems that people want to use are key: this means ensuring that everything can be found in one place, that interfaces are intuitive to use, and that the experience is personalized. Show me the information I want, when I want it.
Should we measure or motivate?
Sponsors and trial monitors often seek historical performance metrics for sites to help select those that are most likely to deliver the best trial progress and outcomes. But, is this the most enlightened way?
The truth is that, when it comes to supporting experienced sites and nurturing novice ones, both measuring and motivating are key. With new data acquisition and analysis tools, sponsors and sites alike can review their progress and react in real-time to take definitive measures to shore up site performance. The key is that this should be considered as a tool to support better conversations between sponsors and sites, not just something that is brought up at the site visit. The sites that perform the best will be those who benefit from sophisticated data insights (presented simply), along with smart support tools, and clear, timely, and personal communication with sponsors.