Who's Wearing The Patient Recruitment Hat When Your Trial Decisions Are Made?

By Ross Jackson, Ross Jackson Consulting

I sometimes wonder whether the ideal clinical trial participant, from the perspective of those designing the study, is six inches tall and made of glass.

A test tube doesn’t need childcare, time off work, or reliable transport. It never objects to a two-hour journey to a research site, six screening appointments, or half a day spent waiting for a procedure. It has no other medical conditions to make it ineligible, no previous treatments to complicate matters, and no days when it feels too unwell to leave the house. Most conveniently of all, it doesn’t have a mind of its own. Real patients do.

I’m making the point deliberately. In many years of working with clinical trial teams, I’ve rarely met anyone who wasn’t committed to developing better treatments. But I’ve seen plenty of studies where well-intentioned scientific, clinical, or operational decisions made recruitment far harder than it needed to be. When those decisions were being made, who was thinking about recruitment? For biotech leaders, whose funding and milestones often depend on the answer, it’s a question worth asking early.

The Recruitment Problem That Started Before Recruitment

Patient recruitment is usually discussed as an operational challenge. Sites aren’t finding enough patients, the CRO is behind target, advertising isn’t generating leads, or screening failures are higher than expected. The conversation then turns to performance: Do we need more sites, more advertising, better investigator engagement, or another recruitment vendor? Sometimes, those are the right questions.

Often, though, the real problem lies in decisions made months or years earlier.

Eligibility criteria are a prime example. Each inclusion or exclusion criterion should have a purpose, whether safety, scientific validity, or regulatory compliance, but each also shrinks the pool of people who can take part. I’ve seen studies where the combined requirements left investigators hunting for unicorns: patients with exactly the right condition at exactly the right stage and none of the co-morbidities or treatment histories common among people who actually live with it.

Patient burden is another. Some studies require several site visits just to complete screening or a test result recorded within a narrow window before enrollment. Both may have sound rationales, but their effect on recruitment needs to be understood. An otherwise suitable patient may be unable to take repeated days off work, may live far from the nearest research site, or may be treated at a hospital without the required equipment. Some will drop out after enrollment for the same reasons, so burden affects retention as well as recruitment.

Sites carry a burden, too. A site that looks capable on paper may lack the time or administrative resources to manage recruitment alongside its clinical responsibilities.

These aren’t necessarily failures of the recruitment team. They follow from how the sponsor designed and organized the trial, and once the protocol is finalized, sites are selected, budgets are agreed upon, and timelines are communicated to investors, they become much harder to change.

The Danger Of Assuming Patients Are Waiting For Us

Another common problem is over-optimism about patient availability. Take a condition affecting a million people across the proposed trial geographies. After applying the eligibility criteria, the estimated population might fall to 100,000. That still sounds like plenty for a study needing a few hundred participants, but how many of those 100,000 can actually be identified? How many are treated at participating sites or by clinicians willing and able to refer them? How many can be reached through patient organizations, advertising, or other outreach? Of those, how many will be interested?

It’s easy to overlook that not everyone who is eligible for a trial wants to take part in one, and that even those who are interested may face practical obstacles.

I suspect some unconscious optimism is at work. The people developing new treatments are passionate about patients’ lives, understand the science, recognize the unmet need, and believe in their treatment. It’s natural for them to assume patients will share that enthusiasm. But wanting a better treatment to exist isn’t the same as wanting to join the trial needed to develop it, and the number of people living with a condition isn’t the number realistically available to enroll.

Introducing The Patient Recruitment Hat

Some years ago, I became interested in Edward de Bono’s Six Thinking Hats, a framework for examining problems from different perspectives. It occurred to me that clinical trial planning could use another hat: the Patient Recruitment Hat.

The idea is simple. Whenever an important trial decision is made, somebody should explicitly consider what it means for recruiting and retaining patients — even when the connection isn’t immediately obvious. It needn’t be the same person each time or even someone with “recruitment” in their job title. Whoever wears the Hat is responsible for making sure the recruitment perspective isn’t overlooked.

Suppose a protocol development team proposes an additional exclusion criterion. The scientific rationale may be compelling: It could sharpen the detection of a treatment effect or address a safety concern. The person wearing the Hat asks what it does to the eligible population, whether that impact has been assessed, and whether the recruitment projections still hold.

Or, suppose the team is choosing between two research sites. One has a strong reputation and a highly regarded principal investigator. The other is less prestigious but has better patient access, more convenient facilities, and more capacity for the study. The Hat prompts the team to weigh those practical differences instead of relying on reputation and experience alone.

The aim is not to make recruitment the overriding consideration but to make sure it is never the missing one.

What Does Wearing The Hat Actually Involve?

I find four habits useful.

Put yourself in the patient’s position. Imagine that you, or someone you love, meet the eligibility criteria. Would you seriously consider taking part or want your loved one to? What if it meant frequent visits, long appointments, or considerable travel while you were already coping with illness, work, childcare, or financial pressure? Rather than relying on what the leadership team imagines patients think, involve actual patients in answering these questions.

Think like the research site. A site may have access to the right patients without the staff, facilities, or capacity to recruit them. How much extra work does the protocol create, and who will review patient records, contact potential participants, arrange appointments, and follow up on interest? A recruitment plan that depends on busy teams doing work they have no time or resources for isn’t realistic.

Challenge the assumptions. What are we taking for granted, what evidence supports our expectations, and what might we be missing? One useful exercise is to ask someone to explain the recruitment process as if to a 12-year-old, without the operational jargon. Where will patients come from, how will we reach them, and why would they consider taking part? Who assesses their eligibility once they express interest, and how do they progress to enrollment? If we can’t explain the process simply, we may not understand it well enough.

Make sure the answers influence decisions. Spotting a recruitment problem is worth little if everyone acknowledges it politely and carries on. Concerns need to be examined and assumptions tested, and the team must then decide whether to change course, investigate further, or knowingly accept the risk. The person wearing the Hat doesn’t need a veto, but their questions must be taken seriously. If a concern is significant enough to influence recruitment, somebody needs to take responsibility for investigating it, and the findings need to inform the decision.

The CEO’s Responsibility

For biotech CEOs, recruitment performance is more than an operational matter. It can determine whether the company meets its clinical milestones, keeps investor confidence, secures its next funding round, and ultimately reaches the market. Yet there is often strong pressure to maintain optimistic projections even when the evidence suggests they are no longer realistic.

Consider a company working toward a six-month recruitment milestone while the CRO and recruitment specialists grow increasingly concerned that the real trajectory is much longer. Does the leadership team examine that evidence and consider what needs to change or keep working toward the original target until the deadline passes and the shortfall can’t be ignored? CROs and recruitment vendors aren’t always right, and not every pessimistic forecast should be accepted. But a milestone is a target, not evidence that the target is achievable.

A CEO doesn’t need to be an expert in every aspect of recruitment or to wear the Hat at every meeting. They do have a responsibility to make sure the organization recognizes recruitment risks, questions its assumptions, and responds to evidence, even when the answers are uncomfortable. That responsibility doesn’t end when the first patient is enrolled. The Hat needs to stay available throughout the study, especially when actual recruitment starts to diverge from the plan.

Don’t Leave The Hat On The Stand

I sometimes picture a meeting room with the Patient Recruitment Hat sitting on a stand beside the door. Everyone notices it on the way in, understands what it represents, and may even agree it’s a good idea. As the meeting goes on and decisions are made, nobody puts it on. Six months later, the team is trying to understand why recruitment is so difficult.

The Hat isn’t meant to create another committee, checklist, or bureaucratic hurdle. It’s a simple habit: Examine decisions through the practical realities of recruiting patients while there’s still a chance to influence the outcome. The ultimate objective is to bring effective treatments to the people who need them, and that can’t happen unless we can recruit the patients required to show those treatments work.

So, at your next trial planning meeting, it may be worth asking: Who’s wearing the Patient Recruitment Hat? It doesn’t have to stay on one person’s head, but it must never be left untouched on the hat stand.

About The Author:

Ross Jackson is a patient recruitment specialist and author of the books The Patient Recruitment Conundrum and Patient Recruitment for Clinical Trials using Facebook Ads.

Having started out with digital marketing in 1998, Ross quickly developed a specialty in the healthcare niche, evolving into a focus on clinical trials and the problems of patient recruitment and retention.

Over the years Ross branched out from the purely digital and now operates in an advisory capacity helping sponsors, CROs, sites, solutions providers, and others in the industry to improve their patient recruitment and retention capabilities — having advised and consulted on over 100 successful projects.