An insight by John Clarke, Associate Director in Patient Recruitment at Indero.
Recruiting patients for clinical trials can be extremely challenging, with many pharmaceutical companies struggling to enrol participants, particularly when existing treatments are already well established.
At the same time, regulatory expectations for diversity in trials are increasing, adding new complexities to recruitment efforts. Trials must not only meet scientific and safety standards but also reflect the real-world patient population demographic to ensure results are meaningful.
This means addressing barriers such as access, awareness and trust while making trials more convenient and engaging for participants.
Understanding patient needs and expectations
Successful recruitment strategies start with understanding what matters to patients. Many individuals hesitate to join clinical trials due to concerns about risks, time commitments or uncertainty over the benefits.
Others may face practical challenges, such as difficulty reaching study sites or a lack of clear information about the trial process.
Designing studies with these factors in mind – by reducing unnecessary site visits, simplifying participation requirements and improving communication – can make trials more appealing and accessible. Patient advocacy groups can also help bridge the gap, providing insights into what patients expect from research, and how best to engage them.
less likely to take part due to logistical and financial barriers. This is a major, commonly known concern, as limited diversity in trials can result in data that does not fully capture how treatments work across different diverse populations effectively.
Sponsors and contract research organisations (CROs) must consider these factors from the outset and develop practical solutions that support wider participation.
The power of patient communities
Many patients rely on disease-specific communities for support, whether through formal advocacy organisations, social media groups or online forums. These networks can be invaluable for clinical trial recruitment, as they connect sponsors with engaged individuals who already have a strong understanding of their condition.
Working with these groups helps researchers to find motivated participants while also ensuring patient voices are considered in trial design. However, one caution with this approach is that these patients may not always reflect the broader population. Those actively involved in advocacy tend to be well informed, proactive and have access to more resources, which could introduce unintended bias into a study. A balanced approach is therefore needed to ensure recruitment remains representative of the wider patient community.
Creating more accessible trials
For recruitment to be effective, clinical trials must be easy for participants to understand and engage with. One of the biggest barriers to recruitment is the complexity of trial information. Patients often struggle with overly technical language, making it difficult to grasp what the study involves and whether participation is right for them.
Using plain-language summaries, visual aids and multimedia content can improve comprehension and boost engagement. Accessibility also extends to trial logistics. Study sites should be easy to reach, with flexible appointment times that accommodate different schedules. Reducing the burden on participants increases the likelihood of enrolment and retention, leading to more successful trials.
A new approach to patient recruitment
Traditional recruitment strategies often focus on eligibility criteria and clinical factors, but a broader approach is needed. Understanding where and how to reach potential participants is just as important as defining who qualifies.
Investigator sites are crucial in this process, as they have local knowledge and experience of working with diverse patient populations. Successful recruitment efforts may involve partnerships with community healthcare providers, outreach through digital platforms, and/or collaborations with local organisations.
Simply advertising a study is not enough – patients must see real value in participation and feel confident that the trial is designed with their needs in mind.
Technology in recruitment and retention
Decentralised clinical trials are making research more accessible by allowing patients to participate remotely. For instance, digital tools – such as mobile apps, wearable devices and virtual consultations – reduce the need for in-person visits, decentralising the collection of study data and making trials more convenient.
However, technology also presents significant challenges, as not all patients have sufficient digital literacy or consistent access to the necessary devices. To prevent exclusion, trials must therefore offer multiple flexible participation options, combining remote and in-person elements where needed.
This flexible approach ensures that technology enhances accessibility, rather than creating new barriers. At the same time, sponsors must carefully manage data collection from different sources to maintain consistency and reliability.
Looking ahead
As clinical research evolves, patient recruitment strategies must continue to adapt. Regulatory bodies such as the European Medicines Agency are placing greater emphasis on inclusivity, pushing for trial designs that reflect real-world patient populations.
While these changes may require upfront investment, the long-term benefits – faster enrolment, better retention and stronger study outcomes – will outweigh the challenges. Focusing on clear communication, practical accessibility improvements and early patient engagement will allow the industry to create a future where clinical trials are not just scientifically rigorous, but also truly patient friendly. This shift will lead to better research, better treatments and, ultimately, better patient outcomes.
