Born to Recruit: Time to Rethink the Site Activation Priorities

The phrase “all politics is local” is well-known and widely accepted. While general attitudes captured in polls can offer some insights, they often fail to capture what truly drives voter turnout at the local level. This principle applies remarkably well to patient recruitment in clinical trials. Despite decades of effort to improve enrollment rates across clinical research sites, less than half of sites consistently meet their enrollment goals. Furthermore, approximately 20% of activated sites fail to enroll even a single patient, according to a study published by the Tufts Center for the Study of Drug Development.

In clinical research, just as in politics, the “local” conditions—site-specific factors and patient demographics—matter. However, the industry's focus has not always been on these critical factors when selecting sites or managing the contract and budget negotiation processes. After decades of working in clinical research, I’ve noticed that often, the sites activated fastest are not necessarily the ones most likely to succeed but rather the ones quickest to complete negotiations. This misalignment has significant consequences for the success of trials.

The Problem: Prioritizing CTA Execution Speed Over Performance

In my experience working on hundreds of Clinical Trial Agreements (CTAs) and budgets with sponsors and Contract Research Organizations (CROs), I’ve observed a troubling trend. Frequently, the teams responsible for contract and budget negotiations are different from those who conducted the initial feasibility studies and selected the sites. As a result, the sites most likely to enroll qualified patients quickly can be pushed to the back burner if they are slower in the negotiation process.

It’s an unintended but costly consequence when the success of patient recruitment is sacrificed for the speed of completing documents. In many cases, the sites that are eager to finalize contracts quickly are less sophisticated or desperate for work. However, they may not have the infrastructure or patient population necessary to meet enrollment targets, leading to delays and, ultimately, trial failure.

This issue is well-documented. A report by the Society for Clinical Research Sites (SCRS) noted that poor site selection and lack of coordination in negotiations are among the leading causes of trial delays. When sponsors prioritize fast contract completion over selecting high-performing sites, they set themselves up for poor recruitment outcomes. The missed opportunity here is staggering.

A Solution: Aligning Team Metrics for Success

So how do we fix this? The solution lies in better team alignment. Sponsors and CROs need to ensure that contract and legal teams' metrics are tied to the same success criteria as the clinical team. The goal should be not just speed in contract execution but ensuring that high-performing sites are activated first. This approach could significantly improve patient recruitment rates and overall trial timelines.

One possible way to implement this would be by creating cross-functional teams accountable for both contract efficiency and recruitment success. This alignment has already been embraced by some sponsors and CROs, with promising results. By holding all stakeholders accountable to the same goals—quick enrollment of qualified patients, successful study completion, and faster regulatory submissions—teams can operate more cohesively, focusing on long-term success rather than short-term wins.

A review published by Applied Clinical Trials also highlighted that integrating site performance data early in the feasibility process and ensuring that this data guides every step from selection to contract finalization is key to minimizing trial delays. These lessons can guide the broader industry to refine its approach, moving beyond a siloed mindset where speed of negotiation trumps site quality.

What’s Next?

Despite the pockets of progress in the industry, there’s still a long way to go. Clinical research needs to embrace the notion that “all recruitment is local.” Tailoring site selection and prioritizing high-performing sites early in the process could drive better results across the board.

So, how do we get there? What strategies have worked for you or your organization to ensure that the right sites are selected and activated quickly? The opportunity to collaborate and share best practices is critical as we look to improve trial success rates and speed up the process of getting new treatments to market.

Let’s continue the conversation—what other innovative approaches can we adopt to ensure better patient recruitment outcomes?

#clincialtrials #patientrecruitment #sitefeasibility #bestpractices #SavingAndImprovingLives

The title of this article draws from the song “Born to Run” by Bruces Springteen, Columbia Records, 1975

References

1. Tufts Center for the Study of Drug Development. Site selection and patient recruitment challenges continue to delay clinical trials. (2020).

2. Society for Clinical Research Sites (SCRS). Understanding barriers to successful site selection. (2019).

3. Applied Clinical Trials. Leveraging site performance data to minimize trial delays. (2021).