Patient recruitment remains one of the most persistent challenges in clinical research. Yet in neuroscience, the challenge is rarely just about finding enough participants. Increasingly, it is about identifying the right patients at the right stage of disease, reducing the burden of participation, and supporting long-term engagement in studies that are often complex, lengthy, and deeply intertwined with patients’ day-to-day lives.

As neuroscience pipelines continue to expand and study designs become more sophisticated, researchers are facing a new challenge: ensuring that increasingly selective eligibility criteria do not unintentionally narrow access to participation. Emerging evidence suggests that factors such as caregiver availability, logistical burden, and real-world patient circumstances can have a profound impact on who ultimately enters a trial.

The organizations that succeed will be those that begin thinking about recruitment long before the first participant is screened.

Recruitment Is Becoming a Data Strategy

For years, patient identification depended heavily on investigator referrals, patient registries, and manual chart reviews. While these approaches remain important, the increasing availability of electronic health records (EHRs), real-world data (RWD), and advanced analytics is fundamentally changing how sponsors and research teams approach recruitment. That availability is now close to universal, and it changes what is possible. Patient data that once had to be assembled site by site can increasingly be queried at population scale. In the United States alone, more than 99% of non-federal acute care hospitals and 91% of office-based physicians had adopted a certified EHR by 2024.

In neuroscience, where eligibility criteria can be highly specific and patient populations difficult to identify, RWD offers an opportunity to understand patient populations earlier and more comprehensively. EHRs, claims data, and other real-world sources can help research teams assess feasibility, identify geographic concentrations of patients, and evaluate potential recruitment pathways before site activation even begins. The Clinical Trials Transformation Initiative recommends that sponsors begin drawing on RWD early in the product lifecycle, before Phase I or formal feasibility work, precisely because that is when eligibility criteria are still adjustable.

This is not theoretical. In a multicentre validation study, text-mining applied to electronic healthcare records was used to screen patients for cardiovascular trials in place of manual review. As Professor Dr. Rick Grobbee, MD, PhD, Chief Scientific Officer at P95 Julius Clinical, has observed, “We’ve shown that the number of patients needed to screen could really be reduced by 80%, and the overall accuracy was about 90%.”

Regulators have moved in the same direction. The FDA’s 2024 final guidance on assessing EHR and medical claims data set out formal expectations for how these sources should be evaluated and used in studies supporting regulatory decisions. For sponsors, that shifts RWD from an optional efficiency tool to a capability that needs to be built deliberately, with the same rigor applied to data quality, traceability and relevance as to any other element of a development program.

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The value of these approaches extends far beyond efficiency. By reducing manual screening efforts, sites can spend less time searching for eligible participants and more time engaging with them. In many ways, recruitment is evolving from a site-level activity into a data-driven capability that spans the entire development lifecycle.

Increasingly, the value of RWD is not simply helping sites find patients faster. It is helping sponsors understand whether their trial designs, site strategies, and eligibility criteria align with the realities of the populations they hope to serve.

The Right Patient Matters More Than More Patients

As neuroscience advances toward earlier intervention and more targeted therapies, recruitment is becoming increasingly nuanced. Studies may require participants with specific biomarker profiles, disease progression characteristics, imaging findings, or treatment histories. Simply increasing outreach efforts is often insufficient when identifying a highly defined patient population.

This is where the convergence of real-world evidence and clinical development becomes particularly valuable.

As Prof. Dr. Grobbee discussed in Unlocking the Power of Real-World Evidence: When to Use It, How to Frame Your Research, and Key Limitations to Consider, one of the primary strengths of RWE is its ability to improve the generalizability of research by helping us better understand how patients are treated and experience disease in routine clinical practice.

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Understanding how patients move through healthcare systems, where they receive care, how diagnoses are made, and what treatment pathways they follow can help sponsors develop more informed recruitment strategies. Rather than asking, “How do we recruit more patients?” the question increasingly becomes, “How do we better understand the patients we need to reach?”

That shift has significant implications for both recruitment planning and site selection.

RWE can play an important role here. By examining how patients move through healthcare systems and by evaluating who is and is not represented in routine clinical practice, researchers can identify potential enrollment barriers before recruitment begins. This can help sponsors design studies that are both scientifically rigorous and operationally feasible.

The Hidden Stakeholder in Neuroscience Clinical Trials: The Caregiver

One of the most important realities of neuroscience research is that trial participation often extends beyond the patient.

In conditions such as Alzheimer’s disease, Amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and other neurodegenerative disorders, caregivers frequently play a central role throughout the study journey. They coordinate appointments, provide transportation, assist with medication management, support protocol adherence, and offer valuable insights into changes in daily functioning.

Yet caregiver involvement is increasingly proving to be more than a retention consideration.

Recent research led by Dr. Lieza Exalto, P95 Julius Clinical Senior Vice President, Neuroscience Medical, offers a compelling example of how RWE can inform clinical trial design. The study examined more than 600 Phase II and III Alzheimer’s disease trials and applied the five most common eligibility criteria to a real-world memory clinic cohort.

The study found that caregiver participation was the second most common eligibility criterion, appearing in 72% of trials. When these criteria were applied to real-world patients, caregiver availability emerged as one of the main reasons women were excluded from trial participation.

The findings revealed that 33% of men remained eligible for participation compared with 23% of women, with caregiver absence accounting for a significant proportion of the difference. Women were more likely to live alone or be widowed, making it more difficult to meet study partner requirements.

Importantly, the findings suggest that recruitment challenges may originate long before a patient is approached about a study. They may begin with eligibility criteria themselves. The implications extend beyond Alzheimer’s disease.

As neuroscience trials continue to rely on study partners, informants, and caregiver-reported outcomes, sponsors may need to think more carefully about how eligibility criteria and study procedures affect participation. Trial designs that accommodate a broader range of caregiver arrangements, including adult children, remote participation, virtual assessments, transportation support, and home-based visits, may help reduce unintended barriers to enrollment.

As Dr. Exalto and colleagues conclude, some eligibility criteria may be scientifically necessary, but study design and execution can still be adjusted to facilitate participation and create more representative trial populations.

Reducing Burden Is the New Recruitment Strategy

The industry has spent years searching for new recruitment channels. Increasingly, however, one of the most effective recruitment strategies may be reducing the need for recruitment in the first place.

When patients remain engaged and enrolled, fewer replacement participants are needed. When sites have fewer dropouts to manage, operational efficiency improves. When caregivers feel supported, retention often follows. This places greater emphasis on study design.

As noted by Bas Nieuwenhuis, Program Head, Project Strategy and Delivery at P95 Julius Clinical, “We need to ensure that trials are feasible and acceptable for participants and that the burden on participants is minimized.”

For neuroscience studies, that may mean incorporating remote assessments where appropriate, leveraging home health services, reducing unnecessary site visits, or simplifying assessment schedules. It may also mean rethinking what gets measured and how. Digital biomarkers and continuous, passive data collection can generate richer longitudinal signal than periodic in-clinic assessments, particularly in neurodegenerative conditions where change is gradual. The caveat is that these tools only reduce burden when they replace something rather than layer on top of it. The goal is not simply decentralization for its own sake. The goal is creating a study experience that fits more naturally into participants’ lives.

Participants are unlikely to think about whether a trial is traditional, hybrid, or decentralized. They do, however, notice when participation feels manageable.

From Recruitment to Research Alliance

Patient-centricity has become a familiar phrase within clinical research, but neuroscience studies often require something deeper than patient-centric design alone. Long-term success depends on building strong partnerships among participants, caregivers, investigators, sites, sponsors, and CRO teams.

Bas Nieuwenhuis refers to this concept as a “research alliance.”

“Explain clearly the objective of the trial, what it means for participants, science, and the community. That’s what we call the research alliance.”

The term is particularly relevant in neuroscience, where participants may remain in studies for years and where meaningful engagement often depends on trust, communication, and shared commitment to advancing research.

The strongest recruitment programs do not begin with a recruitment campaign. They begin with a clear understanding of the people involved and a commitment to making participation worthwhile.

Looking Ahead

Neuroscience clinical research is entering a period of extraordinary innovation. Advances in biomarkers, digital technologies, precision medicine, and disease-modifying therapies are creating new opportunities to address some of the most challenging neurological conditions. At the same time, the demands placed on recruitment strategies are growing.

Success will increasingly depend on an organization’s ability to connect RWD, patient insights, caregiver needs, and operational execution into a cohesive strategy.

As neuroscience trials become more targeted and more complex, recruitment will be shaped less by outreach efforts alone and more by the decisions made during study design, feasibility, and planning.

The future of neuroscience recruitment begins before the first patient is ever screened.

Continuing the Conversation

The future of neuroscience recruitment will be shaped by a deeper understanding of patients, caregivers, and real-world clinical practice. To learn more about these topics: