It’s a foundational truth that all drug development teams are aware of: risk mitigation is a core and crucial part of clinical trial success.

Clinical teams meticulously plan for risks associated with patient safety, site operations, regulatory compliance, and logistics. Yet even through stacks of paperwork and plans, one area of the clinical trial process is consistently overlooked in traditional risk management frameworks: patient recruitment and enrollment.

Recruitment: The Silent Risk Factor

In the U.S. alone, more than 80% of trials fail to meet their recruitment and enrollment goals, and nearly 11% fail to recruit even a single patient. While some would argue that the number might be even higher, the point is clear: recruitment is a crucial risk factor in trial planning.

For many risk management teams, logging a solution to the risk of “patient recruitment” could be seen as being too elementary, or not even worth the time – with a challenge that happens so frequently, is delayed enrollment truly a risk to manage, or is it an obstacle to expect?

Whichever side of the answer you’re on, the ultimate impact of study delay - and potential study cancellation - is worth the extra level of risk planning that other, traditional areas of a risk log require.

Here are three considerations to move beyond reacting to the challenges of patient recruitment, and begin proactively risk planning against one of the most uncertain areas of a clinical trial:

1. Identify an enrollment partner – not a recruitment rescue plan.

We’ve all heard the anecdote around the importance of using the right tool for the right project. While a chainsaw is great at cutting down trees, slicing through lumber, and performing a variety of other tasks, it’s not the best tool for other instances. And that’s exactly how we need to think of—and risk plan against—recruitment and enrollment efforts.

Oftentimes, large sponsors lean on internal teams who are pulled in millions of directions to create, manage, launch, and report on recruitment, while still managing their day jobs at the same time. For smaller and midsize organizations where these teams don’t even exist, the responsibility falls to operational teams to manage on top of everything else that they’re focused on.

When recruitment and enrollment is passed to a CRO, the same challenge exists: CRO teams are focused on site engagement, data management, documentation, regulatory support—the list goes on and on. Again, recruitment and enrollment becomes a small part of a large process, rather than a focus area for success.

For some leaders, the idea of leaning on an additional third-party team to manage recruitment and enrollment is an anxiety-producing thought exercise. And, for good measure. Historically, recruitment and enrollment firms have created a negative narrative in the market by driving high volumes of uninterested, unqualified patients to sites, driving up costs without delivering randomizations.

Choosing the right recruitment and enrollment partner is a risk in and of itself. But making the right choice—and partnering with a team who understands the challenges of recruitment and enrollment at large—can be the key difference between a study that delivers ahead of LPI, and a study that gets canceled due to extended delays. An effective enrollment partner will deliver targeted, qualified patients and deliver clear, measurable outcomes. If your partner can’t make that promise – find the one that will.

2. Conduct Evidence Based, Real-World Feasibility

A feasibility assessment is often referred to during the study design phase, and it’s usually associated with the broad-stroke approach of understanding site access, regulatory timelines, and prevalence data. All of which are incredibly important parts of designing and running a study.

But there’s another side of feasibility that teams rarely dive into: the real-world feasibility of patient enrollment, in real-time.

When feasibility reports are based on historical data, teams are only able to pull insights against a static point in time without compensating for changes at the site level, changes in patient behavior, or changes in the therapy market related to the specific indication.

Your recruitment and enrollment partner should provide a real-time feasibility assessment to understand patient flow, timeline forecasts, and audience barriers before launching your recruitment and enrollment efforts. The promise of RWE on historical assessments is only one part of the equation—and if you’re unable to forecast against real-time data, you’ll continue to see the same recruitment and enrollment challenges on repeat.

3. Define (and continuously monitor) KPIs

Trial teams frequently establish KPIs during initial planning phases but rarely revisit or adjust them throughout the study lifecycle. Yet, enrollment dynamics evolve, and KPIs should reflect and adapt to these changes.

Regularly monitored metrics such as screen-fail rates, randomization rates, and patient dropout rates offer early indicators of enrollment risks. Continuous monitoring and timely KPI adjustments enable teams to swiftly identify issues and pivot their strategies, maintaining alignment with recruitment objectives. Ignoring KPI’s risks perpetuating inefficiencies, resulting in delays and cost overruns.

Recruitment and enrollment is too important to be left to monthly updates, or monthly adjustments. Just as patient behavior changes, the strategic approach to recruitment and enrollment must be a living project that adjusts in real time, responsive to the needs of the patients, and the needs of the trial.

Ready to Risk Planning Your Recruitment Strategy?

Yes, there are additional considerations that teams need to keep top of mind when creating their risk plan for recruitment and enrollment. And, yes, there’s nuance in the ways to do so, and the importance of each approach.

The point is simple: risk mitigation isn’t limited to “every other area” of clinical trials. Teams that proactively risk plan their recruitment and enrollment strategy see enrollment success at a likelihood of 4 times higher than teams who fail to partner and plan their enrollment.

And when every day counts and every trial matters, the ability to be on target faster, more effectively, and with more certainty? That sounds like the easiest risk-log entry one could write.