Designing recruitment for complexity: Capabilities that deliver in today’s trial landscape

The intricacy in trial conduct is also influencing the complexity of the approaches that sponsors need to take to recruit patients or participants who meet the inclusion criteria for the increasingly demanding protocols.

In the past, when recruitment and trial design were less complicated, trial recruitment typically focused on a small number of capabilities. For example, consumer marketing through physical or digital channels could be an effective approach, especially for observational research or studies in therapeutic areas with high incidence, like type 2 diabetes or asthma. In less prevalent therapeutic areas, the capability of data analytics could be useful, wherein organizations might use advanced analytics to identify patients with a rare disease in a large-scale medical registry or healthcare claims dataset.

These represent just two of the most critical capabilities in clinical trial recruitment. While recruitment vendors may have previously offered few capabilities in the past, a much wider range of capabilities are now required to succeed in the complex and competitive trial ecosystem. AI tools and data technologies are clear front-runners in the capabilities race, but we have also seen successful organizations prioritize the external stakeholder (sites, patients, HCPs) experience and enhance internal operations processes that also deliver a high-quality experience to the internal teams that drive the process forward.

Based on our experience working with leading pharma and biotech organizations on clinical trial recruitment, we have identified four essential capabilities that can deliver high quality patient recruitment outcomes. We also provide examples and insights for how clinical operations leaders can drive excellence in each area, without having to onboard multiple technology vendors to help.

Consumer sales and marketing

To an extent, the core capability requirement of clinical trial recruitment is sales and marketing: informing the consumer (patient) about a new product (medicine or other therapeutic) that can help them solve their problem (health condition) and motivating them to expend resources (time, risk, logistics) to try it out (participate in the trial) is the stripped-down version of what trial recruitment seeks to accomplish.

However, the state of the art and science in consumer-facing sales and marketing capabilities have advanced far beyond the standard marketing approach that many trial recruitment organizations take. While maintaining regulatory compliance, trial recruitment organizations can access patients using digital marketing tactics that meet them where they are. Here are a few innovative tactics that can be employed:

• Prioritize digital channels beyond social media: While many assume social media is the best channel, newly diagnosed patients overwhelmingly use search engines first to search for answers about their condition and treatment options. Investing in targeted pay-per-click ads and ensuring top search engine rankings for relevant keywords can effectively reach motivated patients at their moment of need. Sending them to a dedicated website for the clinical trial website optimized for these searches is 74% more effective than relying on ClinicalTrials.gov listings alone. These should explain the protocol in plain language, outline eligibility, include FAQs, and provide site locations. Featuring authentic patient stories further builds trust and fosters enrollment among both patients and their support networks.
• Optimize for mobile: Ensure all digital communications and websites are mobile-friendly. Mobile apps and messaging facilitate ongoing engagement, reminders, and allow participants and potential participants to easily express interest or ask questions at any time. Mobile-first tactics demonstrate results: Indeed, research findings estimate that over half of health-related search queries in the United States are performed on mobile devices as of 2022, and this percentage is expected to rise further in 2025 as mobile usage continues to grow.
• Leverage new data analytics capabilities for marketing: Micro-segmentation can be achieved using AI to segments large patient populations by their relevant characteristics (age, comorbidities, treatment history, digital behavior) to personalize messaging and outreach. This can be further enhanced through omnichannel marketing optimization that leverages machine learning to identify the best combination of communication channels and messages (SMS, email, social media, search ads) to drive the highest engagement for different patient types.

Large scale data analytics

The processes of sales and marketing can be significantly enhanced by large scale data analytics, as described above, but can also be made more effective when the most appropriate potential participants are identified in the first place.

As large datasets of consumer and patient activity have grown, they increasingly maintain information related to patient health and behavior that can deliver valuable insights into a patient’s eligibility to participate in trials for which recruitment may be difficult.

For example, in cases of rare disease trials, patients may be undiagnosed, though they experience symptoms of the condition. Leveraging patient networks and medical records that include large and diverse patient populations, organizations can use data analytics to identify patients who have the rare disease but have not yet been diagnosed. This type of analytical activity can also facilitate global and/or multilingual outreach and reduce the burden on research sites, making the recruitment process more efficient. Similarly, automated pre-screening to scan electronic health records and/or other patient information can determine or confirm eligibility, reducing site staff workload and minimizing screen failures, particularly when inclusion/exclusion criteria are highly complex. Finally, predictive analytics can be applied to analyze a patient’s medical history, demographics, and behavioral data to proactively identify patients most likely to qualify and participate, increasing yield and speed.

Operational efficiency

Previously a highly manual, person-driven capability, recruitment operations functions are increasingly relying on AI and other technologies to manage and track complex processes. An essential operational change that many recruitment operations organizations may need to make is to establish a centralized process that centralizes all recruitment activities, ranging from initial outreach and consent to participant screening and randomization. The unified process reduces data silos and manual handovers and can serve as the basis for other efficiencies and operational improvements, such as process automation and centralized reporting.

• Process automation can be a hugely valuable addition to operations teams, offering improvements such as automated reminders and scheduling that can reduce no-shows and improve visit adherence, while not requiring recruitment operations staff to spend time following up with participants who may have decided not to participate in the trial. Similarly, using automation to model protocol feasibility can support the operations team to test protocol complexity and optimize site and patient fit before referring potential participants to sites that might not be a strong fit for their respective needs.
• Trustworthy and actionable reporting are crucial building blocks of an effective recruitment operations process. While the metrics may vary based on the sponsor’s needs or the specifics of the trial, recruitment funnel analytics are important across all studies to continuously track leads, conversions, screen failures, and enrollment rates. Rather than simply providing metrics, these analytics serve to identify recruitment bottlenecks and guide data-driven decision-making. Benchmarking should also be included in reporting to compare study and/or site success metrics. With benchmarking, organizations can dynamically reallocate resources to high-performing locations or intervene early with under-performing ones.

External-facing tools and technology

Trial participants, healthcare providers, and site staff are highly familiar with the consumer-facing tracking technologies that now govern our consumer lives. These can range from on-demand service provision like Uber to location status updates for an incoming package via FedEx to ordering from an eCommerce site or booking travel online. Their expectations for trial participation or collaboration are influenced by these tools, so design and user experience focused on external stakeholders are essential attributes of the recruitment process.

• Recruitment teams should personalize engagement in the trial by using technology to foster a sense of partnership among all stakeholders. For example, patients can be engaged with effective web or mobile applications as collaborators in research, not just subjects. Regular communications, email newsletters, Q&A channels, mobile apps, and active social media engagement can be employed to keep participants informed and connected throughout the trial process, improving both recruitment and retention.
• Personalization can be further enhanced through behavioral science interventions where technology is built with an understanding of the cognitive barriers and decision-making factors that influence both patients and clinicians. If technologies or tools can address misconceptions, provide clear information, and frame benefits in a way that aligns with their values, they can motivate clinician participation and patient enrollment and engagement.

While data, technology and artificial intelligence will be key attributes in the future of clinical trial recruitment success, their existence alone as part of the recruitment process is not sufficient. Organizations in clinical trial recruitment should consider the full value chain of the process, starting from patient identification via marketing and sales capabilities and consider the long-term engagement of the patient, clinician, and site staff when building external-facing experiences. These tools and technologies will improve the external stakeholder experience and will be further bolstered by high-quality internal operations processes that also deliver a high-quality experience to the internal teams that drive the process forward.

This article was first published in Clinical Leader.