Patient recruitment stands as one of the most critical operations and often challenging phases in the clinical trial lifecycle. Efficiently identifying, engaging, and enrolling eligible participants globally is paramount to the timely and successful development of new therapies. Increasing competition for specific patient populations and geographical dispersion have created a need for effective approaches. Today, technology, specialized service providers, and dedicated patient advocacy groups are transforming how recruitment is conducted worldwide.

     The global clinical trial landscape is characterized by requiring highly specific patient profiles in most cases. This makes finding eligible individuals more difficult. At the same time, we have observed a peaking call for greater diversity and representation in clinical trial populations to ensure that study results are broadly applicable. This is met by public scrutiny of new interventions, easily interpretable evidence, and even drug pricing in the periphery. This drive for efficiency, specificity, and diversity has accelerated the creation of new startups and adoption of new strategies and technologies. A major trend is the move towards decentralized or hybrid trial models and will be discussed more thoroughly in a later article.

     Technology is playing a transformative role in overcoming recruitment hurdles. Software-as-a-Service (SaaS) and Solution-as-a-Platform (SaaP) models are providing scalable and integrated tools to streamline the process. They leverage data analytics and sometimes Artificial Intelligence (AI) to identify potential patients within large datasets, such as electronic health records (EHRs) or patient registries, based on complex inclusion and exclusion criteria. These platforms also fall under the category of Health Information and Management Systems.

Examples of technological applications include: Patient Matching Platforms: SaaS platforms that integrate with healthcare systems or leverage de-identified data to match patient profiles with suitable clinical trials. Direct-to-Consumer Marketing: SaaP solutions offering comprehensive digital marketing capabilities, allowing sponsors and CROs to run targeted online campaigns to reach specific patient demographics via social media, patient communities, and health websites. Centralized Databases and Registries: Technology platforms hosting patient registries for specific diseases, enabling researchers to connect with interested and potentially eligible individuals. E-consent and Remote Screening: Technology facilitating remote informed consent and initial screening processes, making participation easier for geographically dispersed patients.

•      The benefit of these technologies is difficult to quantify from a practical business perspective and instead should be considered as operational improvements that can reduce risk of clinical trial recruitment failure.

     To be successful in evidence generation activities necessary for regulatory approval, market access, or market expansions, pharmaceutical and biotechnology companies rely heavily on expert partners for recruitment. Pfizer and AbbVie are examples of organizations that have established their own network of trial sites globally and recruit that way. Clinical Research Organizations (CROs) are central to global recruitment efforts, offering end-to-end services from trial design consultation to patient enrollment. For example, large CROs like Syneos Health, IQVIA, Parexel, or PPD, leverage their extensive global site networks, regulatory expertise, and increasingly, proprietary technology platforms to execute large-scale recruitment campaigns.

Tactics are ranked by effectiveness and include: Global Site Optimization: Identifying and partnering with clinical sites that have access to relevant patient populations and a proven track record in recruitment. Physician Referral Networks: Engaging healthcare providers who can identify eligible patients within their practice. Improving Site Performance: Providing training and resources to research sites to help them optimize their local recruitment processes. Patient Databases and Registries: Utilizing or building databases of potential participants who have expressed interest in clinical research. Localized Outreach: Developing culturally sensitive recruitment materials and strategies tailored to specific regions and patient communities globally. Digital and Social Media Campaigns: Designing targeted online advertisements and content to raise awareness about trials among specific patient groups.

    Patient advocacy groups play an indispensable and increasingly appreciated role in patient recruitment. These organizations have established trust and deep connections within specific disease communities to represent them and provide guidance on pertinent subjects like data-driven societal perspectives of cost-effectiveness measures to external stakeholders such as business executives or consultants. They serve as invaluable partners by: Building Trust: Helping to build confidence in the clinical trial process within patient communities, which can be particularly important for underrepresented populations or in regions with historical mistrust of medical research. Raising Awareness: Educating patients and their families about clinical trials as a care option. Providing Insights: Offering patient perspectives on trial design, potential burdens of participation, and effective communication strategies. Connecting Patients to Trials: Acting as trusted intermediaries, sharing information about relevant trials with their members and sometimes facilitating direct connections with research teams.

• For example, disease-specific foundations dedicated to rare genetic disorders or particular types of cancer often maintain patient registries or actively disseminate information about ongoing trials to their members, significantly aiding recruitment efforts for challenging studies. The collaboration with patient advocacy groups provides essential community access, trust, and invaluable patient insights. As clinical trials become more complex and global, the incremental benefit of new therapies becomes more challenging to prove, synergy between technology, commercial expertise, and patient partnership will be increasingly vital to accelerating the pace of medical discovery and bringing much-needed therapies to patients worldwide.