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Where are all the patients? How to recruit participants for real-world research

  • July 17, 2024
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The choice of recruitment approach for real-world research can have a significant impact on study timelines, costs, and population composition, making it a crucial decision for study investigators. In this blog, we will discuss a number of tried-and-tested recruitment approaches from real-world patient-centered studies that we design and run for our clients, alongside operational considerations and potential outcomes.

What are the key recruitment approaches that can be applied in real-world research?

Community recruitment. This can include recruitment via patient advocacy or support groups, social media, or word of mouth. Participants are recruited without ever needing to visit a healthcare setting or study site. In our studies, community recruitment typically involves a person receiving information about the study, registering through an app or website, and providing self-reported data via their own internet-enabled device. At Vitaccess, our strong existing relationships with patient advocacy groups across therapeutic indications enables our clients to benefit from community recruitment drives.

Recruitment agency. Specialist recruitment agencies can identify and approach potential study participants on behalf of the research team. An agency may have a database of contactable patients or members of the public on its record who have either expressed interest or previously participated in healthcare research. They may also use some of the tools of community recruitment, for instance actively advertising the study on social media or via patient groups. Agencies may have networks of healthcare professionals with whom they are in contact who may then reach out to specific patient groups to share details about the study. We have successfully partnered with several trusted third-party agencies in our studies, enabling quick and effective study recruitment.

Site-based recruitment. Participants are recruited by a healthcare professional acting on behalf of the study team. A patient’s doctor may discuss the study with them during a routine consultation, or a member of site staff (e.g., a research nurse) may scan medical records to identify potentially eligible patients and contact them via email or phone. Depending on the needs of the study, site staff may go as as confirming eligibility, guiding patients through the consent and registration process, and entering data. Alternatively, they may merely pass on information to patients who can then choose to enroll remotely (e.g., via a study app).

What factors should be considered when deciding on the recruitment approach(es) for your study?

The choice of recruitment approach(es) can have a significant impact in terms of study population, operational considerations, costs, and timelines. Table 1 compares community-, agency-, and site-focused recruitment according to these categories.

 

Table 1: Implications of different recruitment approaches in real-world research
Study population
Study population
Study population
Study population
Study population
Study population
Study population
Planning and strategy
Planning and strategy
Data quality
Cost
Cost
Logistics
Logistics
Ethics
Ethics
Community recruitment
• Potential to reach a large and diverse pool of participants.
• Opportunity to engage underrepresented populations by targeting specific community groups.
• Can be time-consuming and less predictable.
• May require significant effort to gain trust and participation from community members.
• Potential for higher rates of ineligible participants due to less controlled environments.
• Risk of self-selection bias; those who volunteer may not represent the broader population.
• Requires planning to identify target communities, develop outreach materials, and establish trust.
• High flexibility in tailoring the recruitment approach based on the specific community’s characteristics.
• Variable, as it depends on the method of collection and the participants’ accuracy in self-reporting.
• Generally cost-effective in terms of direct expenses but can incur high indirect costs in staff time and outreach efforts.
• Funds needed for community events, outreach materials, and possibly incentives for participants.
• Requires coordination and scheduling to engage participants and ensure follow-up.
• Ongoing monitoring needed to assess the effectiveness of recruitment strategies and adjust as necessary.
• Typically quick and straightforward.
• Often sufficient to apply to a single independent commercial Institutional Review Board (IRB), the submission process for which is usually straightforward.
Recruitment agency
• Agencies often have access to large databases of potential participants.
• May be more predictable and faster in reaching target sample size due to their resources and expertise.
• Typically expensive due to service fees.
• The quality of participants may vary based on the agency’s vetting processes.
• Potential discrepancies in the agency’s understanding and application of eligibility criteria.
• Potential for bias if the agency’s database lacks diversity.
• Less time-consuming than community recruitment as agencies have pre-existing databases and outreach mechanisms.
• Agencies handle the bulk of the engagement process, leveraging their expertise and resources.
• Generally high, as agencies use standardized methods for screening.
• Higher upfront costs due to agency fees.
• Agency fees cover most aspects of recruitment, reducing the need for additional internal resources.
• Coordination is less complex, as the agency coordinates most logistical aspects.
• Need to monitor the agency’s performance and compliance with study criteria.
• Typically quick and straightforward.
• Often sufficient to apply to a single independent commercial Institutional Review Board (IRB), the submission process for which is usually straightforward.
Site-based recruitment
• Direct access to a population already engaged with the site, such as a hospital or clinic.
• Often easier to achieve target numbers if the site has a large patient base.
• Access to medical records and direct communication with healthcare providers facilitates eligibility verification and high-quality data.
• Patients’ trust in their healthcare team often predicts higher engagement levels.
• Limited to the site's patient population, which may restrict sample diversity.
• May face competition with other studies recruiting from the same site.
• Complexity of working with sites may impact timelines and expenses.
• Involves coordination with site staff and integration with site workflows.
• Relies on site staff (e.g., clinicians, nurses) to identify and engage potential participants.
• High, due to access to verified medical records, data reported by healthcare professionals, and direct verification of eligibility criteria.
• Site budgets can be high, depending on the country, individual site, complexity of site involvement, etc.
• Costs associated with site engagement, resourcing, training site staff, and possibly providing incentives for participation.
• Requires extensive coordination between the study team and site staff; scheduling can be streamlined within the site’s workflow.
• Regular monitoring is needed to ensure adherence to study protocols and recruitment targets.
• Gaining approval to conduct research through a country’s national healthcare system usually involves mandatory submission to a central approval body, the process for which is often complex, as well as submission to local research and development bodies or ethics committees at study sites.
• The ethics process and site recruitment often become interdependent.

Take-home messages

Recruitment is often one of the biggest challenges for study sponsors when conducting real-world research. Each recruitment strategy has its own set of strengths and weaknesses, and the best approach depends on the specific needs and context of the study. Combining multiple recruitment methods can often mitigate the limitations of each individual strategy and enhance overall study outcomes.

By initiating a real-world patient-centered study with Vitaccess, you will benefit from our team’s experience in successfully implementing a range of recruitment approaches across study designs and therapeutic areas. Our team can manage community, agency, and site-based recruitment from study start to finish.

To learn more, contact our team at info@vitaccess.com.

By Geraldine Hall, Emma Bagshaw, and Fatemeh Amini

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