Nobody wants a delay in site activation for a clinical trial. Every delay increases study budgets and reduces the time for market exclusivity. A delay means patients aren't getting needed drugs. Yet delays happen – consistently. So what is the secret to swift site activation? What is the "special sauce" to speed up the process and get studies started on time?
Actually, there is no secret. No mystery. No complicated formula. The fact is, speeding up site activation is as easy as 1-2-3.
1. Practice Leadership at Every Level
In the study startup process, leadership is required at all levels: sponsor, CRO, and site. In particular, sponsors need to provide leadership in the form of delivering the goal and vision for the clinical trial. CROs and sites need to have a clear picture of where they are going in order to plan the journey effectively.
CROs and sites, in their turn, need to think beyond "project management" and "coordination" to true leadership by taking ownership of all the myriad tasks that must be completed to ensure a timely startup. Whereas project managers excel at tracking the details of what is being accomplished and what still needs to be accomplished, leaders proactively drive matters forward to get the job done by supplying strategy, motivating employees, removing obstacles, and securing resources.
2. Engage in End-to-End Oversight
With so many players – sponsor, CRO, vendors, sites, clinical operations, etc. – it is easy to drop the baton during trial startup. For example, a CRO sends an email to a vendor requesting certain information. Two weeks later, the sponsor realizes that startup has been delayed because the vendor has not provided the information and no one had it on their radar to follow-up.
Here is where project managers and coordinators for each stakeholder come into their own. Rather than passing the baton and sitting back to wait for a reply, oversight involves project managers and coordinators following up promptly if a required action is not forthcoming. Essentially, oversight means taking responsibility not just for the tasks on hand, but also for tasks that may have been passed on to another stakeholder.
3. Keep Communication Flowing
Communication is the lifeblood of every clinical trial. To facilitate good communication, it is critical, first, to streamline points of contact between stakeholders. If there are eight people from the sponsor talking to ten people at the CRO who are in contact with six people at the site, then there is ample opportunity for misalignment, misinformation, and mismanagement … and missed timelines.
Second, good communication depends upon setting up regular checkpoints. Consistent meetings between stakeholders to discuss timelines, accomplishments, and obstacles ensure that study startup stays on track.
So, is this really as easy as 1-2-3? Actually, no. Leadership, oversight, and communication, while they are not difficult concepts to grasp, can be very challenging to execute. Nevertheless, the return on investment is more than adequate, as improving the site activation process significantly speeds up clinical trial start dates, setting a solid foundation for a successful study.