The Protocol Is the Recruitment Plan (Whether You Like It or Not)

How early decisions lock in future success – or set your enrollment up to struggle.

You know that moment when the protocol finally gets approved… and someone quietly asks, “So… how are we going to enroll for this?”

Yeah. That.

If your protocol is rigid, overcomplicated, or exclusionary-by-default, your recruitment plan might already be limbering up for a screen fail obstacle course – with a blindfold and a stopwatch.

You just haven’t met the coordinator who has to screen for it.

For years, the industry has treated recruitment and protocol development as two separate timelines – with the former often treated as a downstream rescue function. But here’s the hard truth: once the ink dries on your protocol, 80% of your enrollment fate is already sealed.

At CLINVANA, we believe patient access, engagement, and inclusivity start on page one – not after the protocol is finalized. That’s why we bring the Human Protocol™ into the earliest conversations possible. Because trials don’t just earn trust with good intentions – they earn it with good architecture.

Protocol assumptions shape participant possibilities

Most protocols are crafted with extraordinary attention to scientific rigor – the result of painstaking collaboration, iteration, and deep clinical expertise. That level of discipline is essential.

But even the most carefully designed protocols can unintentionally narrow access when human context isn’t part of the equation. Visit schedules, assessment loads, and eligibility criteria may all make sense scientifically – but still create unseen burdens for the very people you're trying to enroll.

At CLINVANA, we believe that when scientific integrity is paired with human insight, protocols become more than feasible – they become functional, inclusive, and ultimately, more powerful.

Protocol complexity is the silent dropout driver

Everyone focuses on how protocol design affects enrollment. Fewer ask how it affects retention.

A patient may agree to a study because they want access to innovation – but they stay because they’re not stuck in a protocol-shaped obstacle course.

If your protocol has 22 visits in 16 weeks, 4 fasting blood draws, and 3 co-pays worth of transportation costs... it may all be scientifically necessary – but it also introduces barriers that can challenge real-world participation. That’s not a failure in design – it’s an opportunity to revisit the human layer that sometimes gets engineered out during iteration.

CLINVANA’s take? If your protocol isn’t calibrated for real life, no amount of reminders, ride-shares, or retention toolkits will save it – though we’d be happy to design all of those too, with more charm and fewer PDFs – and always with full IRB or EC approval where applicable.

Your feasibility forecast needs a vibe check (and a site coordinator)

A feasibility report that says, "We can do this" is not the same as one that says, "Patients want to do this."

Too many studies use retrospective enrollment data from unrelated studies or a few expert site interviews as the basis for feasibility. It’s like designing a shoe for a population you've never walked among.

Real-world feasibility isn’t just about enrollment rates – it’s about understanding the expectations, burdens, and trade-offs experienced by site coordinators who actually operationalize the protocol. Their history with similar studies, competing trials, and internal workflows often reveal friction points that broader modeling misses – and let’s be honest, they probably already know which visit schedule is going to tank your dropout rate before you even load the study in your CTMS.

These insights are best uncovered before the protocol is final – not after the first screen failure report lands.

CLINVANA’s feasibility insights layer in patient, caregiver, and site perspectives so protocol design isn’t just clinically sound – it’s Zenrollment™-ready. Because when you map for reality, your strategy doesn’t stall out at first contact.

The best recruitment plan is a well-written protocol

This doesn’t mean recruitment strategy doesn’t matter – of course it does. But the most effective recruitment teams are those that are brought in before the protocol locks in its DNA.

At CLINVANA, we’re often engaged when recruitment is struggling. But the truth is, we do our best work when we’re brought in early – to offer insight, language, and structural feedback (always routed through appropriate IRB review when required) that can preempt the need for rescue altogether.

Want to run a smarter trial? Start by designing one that reflects the needs and realities of the people you're asking to join – without compromising the science that brought you here.

Let’s un-silo strategy

Patient recruitment doesn’t always have to be a rescue mission – it’s a design discipline.

If you want to increase enrollment and reduce dropouts, you don’t need louder advertising. You need quieter assumptions. You need clarity, early collaboration, and a protocol designed with humanity in mind.

This is what we do.

Let’s build trials that don’t just work on paper – they work in real life. That’s how trials earn trust™ – and honestly, it’s a lot more fun than chasing down rescue plans and wondering if ‘Protocol_v3.3_FINAL_FINAL_REALLY_FINAL’ will finally stick.