Feasibility and Site Strategy 

Realistic feasibility is one of the most important factors in recruitment success, as over-optimistic projections based on theoretical patient numbers can lead to significant delays once a study begins. In contrast, robust feasibility assessments with site-level knowledge improve predictability and reduce the risk of unexpected shortfalls in enrolment. Investigative sites are central to this process, as they understand their local patient populations, referral pathways, and the practical barriers that may affect participation. Engaging sites early, and incorporating their input into feasibility planning, allows more accurate forecasting and better alignment between recruitment targets and actual capacity. 

Effective recruitment also depends on strategic site selection, and simply increasing the number of sites does not guarantee faster enrolment. Focusing on experienced sites with access to the right patient populations can be far more effective. Expanding into new geographies also extends recruitment reach, particularly where access to treatment differs, but this must be balanced with an understanding of local healthcare systems, regulatory requirements, and patient access dynamics. 

Designing Protocols That Patients Can Follow 

Intelligent protocol design should consider participation from a patient’s perspective and must be manageable within the context of daily life. The frequency of visits, duration of the study, and overall burden of assessments all influence whether individuals are willing and able to enrol and remain in a study. Sponsors are often motivated to maximize data collection, but time-consuming and invasive procedures can discourage patients, regardless of the potential benefits of the investigational treatment. Resolving this requires an approach that distinguishes between essential and non-essential endpoints. Focusing on the data required to answer the primary research question, rather than capturing every possible variable, can reduce patient burden and improve both recruitment and retention.  

Transparency, Accessibility and Diversity in Recruitment 

Improving recruitment outcomes depends on aligning trials with patients’ needs, and direct patient input is key to this. Without it, there is an inherent risk that protocols will fail to reflect real-world experiences, leading to lower participation and higher dropout rates. Patient associations and community networks provide valuable perspectives on the participant’s journey, helping to shape more relevant study designs and improve communication strategies. They also act as trusted intermediaries, fostering engagement and helping to build confidence in the research process. For many individuals, clinical trial participation is an unfamiliar experience, so making communication clear and accessible in simple, non-technical language is essential. Diversity also remains a complex challenge due to barriers such as socioeconomic constraints, limited access to sites, and varying levels of digital access. A holistic approach is required, combining targeted site selection, tailored outreach strategies, and flexible study designs to ensure that participation is both accessible and inclusive. 

Aligning Stakeholders to Improve Recruitment Outcomes 

Alignment between sponsors, CROs, and investigative sites is also essential to effective recruitment, as each stakeholder brings a different perspective: sponsors focus on scientific objectives, sites on patient care and feasibility, and CROs on execution and delivery. Inefficiencies can arise when these perspectives are not aligned, making strong collaboration essential. CROs play an important role in translating study objectives into practical, executable protocols, while also ensuring that site and patient considerations are fully integrated. They work closely with both sponsors and sites to help identify potential risks early, refine feasibility assumptions, and maintain consistent execution across regions. Complex, multi-centre studies are particularly dependent on coordinated, realistic and adaptable recruitment strategies to ensure trials can proceed smoothly, especially when there is variability across sites and regions. 

Strategic Approach to Recruitment 

Patient recruitment challenges are unlikely to be solved through isolated tactics alone. A more holistic approach is required, considering feasibility, site strategy, protocol design, and patient engagement as interconnected elements. Embedding patient involvement, improving feasibility accuracy, and strengthening collaboration between stakeholders can help to reduce variability and improve predictability in recruitment outcomes. These approaches may require greater investment upfront, but they offer significant long-term benefits, including faster enrolment, improved compliance, and more reliable data. Future clinical trial success will rely on study designs that are both scientifically robust and strategically aligned with the realities of the patients they aim to serve. 

John Clarke, Associate Director of Patient Recruitment at Indero, holds a MSc in Clinical Exercise Physiology. John has more than 15 years’ experience in clinical research, including 10 years heavily involved in patient recruitment. He also has several years’ experience in website development and social media campaign management. John’s expertise spans problem-solving, data analysis, qualitative research, statistics, critical thinking, and customer relations. His leadership style is rooted in hard work, respect for individuals, collaboration, and a commitment to bringing out the best in everyone. John’s approach, combined with his extensive experience and skills, make him an exceptional figure in the field of patient recruitment. He can be reached at jclarke@inderocro.com.