Achieving person-centricity in clinical trial recruitment: Insights and examples from the consumer technology industry

As clinical trial recruitment increasingly focuses on digital channels to identify and enroll participants, clinical operations leaders can look to trends and innovations in the consumer technology industry for inspiration to improve the recruitment experience for patients and speed to market results for businesses.

Consumer technology use cases mirror clinical trial recruitment throughout the entire process. For example, digital marketing capabilities can be used to inform patients of relevant opportunities to participate in research in the way eCommerce companies serve personalized advertisements to consumers. Simple, clear language and technology interfaces can be used to communicate important, complex ideas to potential trial participants in the way job recruitment technology products inform applicants of the requirements and expectations of a role. Even the online dating experience is relevant to trial recruitment as users can tighten or loosen the criteria for a potential match.

Based on our experience in clinical trial recruitment and consumer technology, we have identified several important challenges throughout the process. This piece will explore where opportunities for consumer technology capabilities could intervene, thus offering a better experience to would-be trial participants that will ultimately lead to faster and better-quality recruitment outcomes, bringing new, essential medicines to patients.

Find potential participants

One significant challenge facing clinical trial enrollment is that recruitment often stalls because it is not possible to find enough qualified, interested potential participants.

In such situations, broadening the search approach to generate new leads, leveraging existing gathering places of interested participants, and improving inbound search functionality are all valuable solutions.

Marketing capabilities for clinical trial enrollment opportunities have advanced significantly, moving from broad-brush tactics, such as advertisements on public transit to more targeted promotion. These include leveraging social media marketing and other ad placements based on consumers’ online behavior. Though progress has been made, more can be done to find potential trial participants and optimize for outreach directed to the candidates who are most likely to be qualified and interested.

Increasingly, online disease communities are attracting attention as spaces where patients congregate to socialize and to learn about treatment and trial opportunities. There has been significant market activity with companies like MyHealthTeam being acquired by Swoop, a healthcare marketing company. Healthcare data registries like NMDP (formerly BeTheMatch) also hold clinical and biometric data that can be searched to identify clinical trial or intervention participants based on data they have provided. Direct-to-patient, proactive engagement efforts can cultivate a community of potential enrollees who can be “activated” when a trial opportunity presents, rather than waiting to start trial recruitment when a therapeutic is ready for clinical trials. The National Institute of Health Research has successfully implemented this approach in dementia research, by launching a public- facing web portal to help interested volunteers be matched with researchers.

For highly motivated patients who are eager to participate in clinical research, an improved inbound search experience is essential. Leveraging high-quality search interfaces built on principles of search engine optimization and content marketing will improve the patient search experience. This change can be made at a centralized, government level on ClinicalTrials.gov, or in a more targeted way based on patient needs. For example, participants may be likeliest to identify with their health condition rather than a particular sponsoring company or study site, so organizing trials in a searchable way at the disease level could be the most patient-centric approach.

Assess potential participants for a good match

Once potential participants are found, the next challenge begins. Inclusion criteria for clinical trials is often extremely rigid at the start of recruitment, leading to erroneous disqualifications.

To overcome this, increasing flexibility in recruitment for patients who may meet most, but not all, inclusion criteria for early screening before rendering them ineligible can be a significant differentiator. This approach can be streamlined by engaging target populations in protocol development, learning about their experiences, and evaluating the typical characteristics that are related, but not as central, to the presentation of their condition.

This collaboration can also shed light on the nuances and complexities of serious diseases for which experimental treatments can be most useful. Once the protocols and the inclusion criteria are defined, increased flexibility could be achieved by testing with a trial run model, based on historical or other real-world data before finalizing inclusion criteria in the trial protocol. Implementing a test of the inclusion criteria can prevent delays further downstream in trial conduct in the case that they later identify that the criteria may have been too restrictive and ensure that recruitment can progress at pace.

Once potential participants have given notice of their interest, they are required to provide additional information about their health and demographic characteristics to ensure that they meet the inclusion criteria of a clinical trial protocol. Unfortunately, protocol inclusion and exclusion criteria can be too restrictive, ruling out potential participants who are excluded based on attributes that may not be relevant to the study’s internal or external validity. Often, this exclusion happens early in the screening process.

In consumer technology use cases where applicants are assessed according to a set of standards, such as job application boards or online dating experiences, criteria can be adjusted based on individual circumstances. For example, HiringBranch uses conversational AI to tailor assessment content to specific roles and industries, allowing for a more nuanced assessment. In the case of online dating, KeeperAI has developed a tool based on US Census data that informs users of dating apps how realistic their standards are when they are looking for a match, either online or in the real world. When applied to clinical trials, insight like this could help researchers to prioritize their inclusion and exclusion criteria, taking a more dynamic approach that can accelerate recruitment and avoid unnecessary disqualifications too early in the process. Additionally, there are job application sites that offer a score or assessment of a candidate’s fit for a role. Many applicant tracking systems offer scoring tools that allow hiring managers to create and weigh such criteria. A similar process could be accomplished in clinical trial recruitment, with criteria related to the individual and the study applied to assess the potential match, offering a likelihood score of enrollment for each interested participant.

Maintain person-level data

Effective management and governance of data in clinical trial recruitment is fundamental to study success. In the trial lifecycle, information about a potential participant is maintained in disparate forms and systems at the study level, rather than the patient level, requiring each study to begin recruitment processes anew.

The solution? Maintaining person-level data to facilitate analysis and outreach to individuals, regardless of their specific study of interest.

Rather than storing data at the pre-screener or study level, patient data about a potential participant should be stored and maintained at the person level, using technologies to link pre-screener questionnaires that are tied to different trials into individual patient records.

This approach to data management will facilitate the maintenance of a high-quality database that can be queried to identify and match patients to potential studies, without having to recommence the clinical trial recruitment process for each study. For example, if a patient completed a pre-screener questionnaire for an asthma study but did not meet the inclusion criteria or dropped out of consideration due to personal availability constraints, they can be re-engaged to participate in another study that might better suit their needs. This cross-study approach to engagement mirrors how many multi-brand companies store consumer data in a centralized data platform and can engage with consumers across brands, rather than isolating their engagement to a single brand where the consumer made initial contact. Excellent data governance practices are essential in maintaining person-level data in the clinical trial context. Ensuring that there are clear lines of accountability for stakeholders managing the data, and that best practices in data privacy and patient consent are maintained will help to build trust and deliver high-quality trial recruitment outcomes. Finally, patients must have control for how and in what situations their data can be queried and used for analysis, prioritizing informed consent and privacy when dealing with person-level data.

Allow participants to view their own progress by creating transparent, centralized approaches to monitoring

Oftentimes, potential participants drop off from consideration for a clinical trial because they have not heard from the trial site, sponsor, or study coordinator and do not know their status.

This indicates a greater need for process transparency to internal and external users – participants and study coordinators – to set expectations and provide information on next steps.

Lead nurturing is a key digital marketing capability, with eCommerce businesses reporting statistics on the success and effectiveness of the approach to keep in touch with sales-ready leads, such as shortened sales cycles and increases in revenue. Lead nurturing can also be used in the context of clinical trial recruitment in cases where a potential participant abandons a pre-screener; they could be emailed to prompt them to complete the survey.

The lead nurturing capability, along with other digital marketing capabilities, can also facilitate tracking of a potential participant’s progress through the recruitment funnel. Consumer technology and products companies like Uber Eats and DoorDash offer customers a tracker experience to view in real time the status of their order and, similarly, product management and customer support tools like Zendesk or Trello use tracking to monitor the status of tasks or tickets that need to be completed.

Providing a similar level of transparency to potential clinical trial enrollees on their status can improve their user experience and retention in the trial recruitment process. Trackers can provide users with a visual representation of their progress, informing them of next steps and requirements, and help them to set expectations for when they can expect to next be contacted. These tools can also be used for internal use cases, increasing accountability for study coordinators to follow up on tasks and maintain engagement throughout the funnel, and could even introduce features of two-way communication through which patients or participants could update their health status or relevant eligibility factors Furthermore, patients could use these tools to reach out to sites or study coordinators to prompt action or seek information on their potential involvement in studies.

Recruiting and enrolling participants into clinical trials is an essential step in the drug development process. Potential trial enrollees are influenced by the digital experiences they have in their consumer lives. Healthcare stakeholders and clinical trial companies alike can learn from consumer technology companies to create high-quality online experiences, driven by data to find, assess, and track interested trial candidates.

Clinical operations organizations can find enhanced success by using these contemporary marketing approaches to find and identify qualified patients and participants, gathering and maintaining their data at the person level, rather than at the study or questionnaire level. They can also update the way they assess potential matches; first collaborating with participants to create protocols with relevant and achievable inclusion criteria, then testing and implementing it with some flexibility to ensure that studies have a strong likelihood of successful recruitment outcomes. Finally, introducing additional transparency and trackability into the recruitment process can give participants and other research stakeholders confidence in the quality and timeliness of the information being shared, and their requirements and expectations throughout the process.

This article was first published in Clinical Leader.