Recruiting the right participants is the foundation of every successful clinical trial. In a landscape where over 80% of trials struggle to meet enrollment targets and timelines are often delayed, effective patient recruitment in clinical trials is a critical factor.
While innovative approaches for patient recruitment for clinical trials have been discussed in a previous article, this guide offers a practical step-by-step patient recruitment roadmap for sponsors, CROs, and research professionals seeking to overcome persistent recruitment challenges and deliver results.
FAQs: Patient recruitment in clinical trials
What does recruiting mean in a clinical trial?
Recruiting refers to the process of identifying, reaching out to, and engaging potential participants who may be eligible for a clinical trial. This phase ends once a participant provides informed consent and is officially enrolled.
How do you recruit patients for clinical trials?
Patient recruitment involves defining eligibility, creating compelling outreach materials, engaging sites, launching digital and offline campaigns, and pre-screening candidates. Clariness patient recruitment services offer end-to-end solutions for every step.
Who is responsible for patient recruitment in clinical trials?
Responsibility for patient recruitment in clinical trials is shared between sponsors, site management organizations (SMOs), and sometimes investigators. Each plays a role in outreach, screening, and supporting participants. Learn more about sponsor support.
The importance of patient recruitment in clinical trials
Timely and effective patient recruitment in clinical trials is essential for ensuring that studies are completed on schedule and within budget. When recruitment lags, timelines extend, costs escalate, and the opportunity to bring new therapies to patients is delayed. For sponsors, every day a trial is delayed can mean significant financial losses and missed opportunities for innovation.
Beyond timelines and budgets, robust patient recruitment strategies in clinical trials are vital for scientific validity. Trials must enroll diverse and representative patient populations to ensure results are generalizable and regulatory requirements are met. For example, a diabetes trial that only enrolls young adults may fail to capture how the treatment works in older populations or those with comorbidities.
In addition to that, inadequate recruitment can undermine the credibility of the research, lead to underpowered studies, and ultimately result in failed approvals. This is why sponsors are investing in advanced clinical trial patient recruitment strategies and global outreach to maximize their chances of success.
The difference between patient recruitment and enrollment
It’s important to distinguish between patient recruitment and enrollment, as these phases have different goals, activities, and implications for planning and reporting.
| Aspect | Patient Recruitment | Patient Enrollment |
| Definition | Identifying and engaging potential participants | Securing informed consent and starting study |
| Activities | Outreach, advertising, pre-screening, referrals | Consent process, baseline assessments, randomization |
| Key Metrics | Number contacted, screened, referred | Number consented, enrolled, randomized |
| Timing | Early to mid-trial | Mid |
| Implications | Impacts awareness, diversity, and speed | Impacts data quality and study power |
Step-by-step guide to patient recruitment
A structured, step-by-step patient recruitment process is essential for reaching enrollment targets efficiently. Here’s how to approach patient recruitment in clinical trials systematically:
- Define the target patient profile
- Collaborate with clinical experts and epidemiologists to specify inclusion/exclusion criteria
- Analyze epidemiological data and real-world evidence to estimate eligible patient numbers
- Use study feasibility services to validate your assumptions and identify recruitment barriers early
- Create compelling recruitment materials
- Develop patient-friendly study descriptions, consent forms, and outreach content
- Ensure materials are culturally sensitive and available in multiple languages
- Leverage study creatives and materials designed for clarity, engagement, and regulatory compliance
- Engage with investigators and site staff
- Train site teams on study protocols and recruitment expectations
- Foster open communication channels for sharing feedback and best practices
- Use site engagement resources to empower sites as recruitment partners
- Implement digital and offline outreach campaigns
- Launch targeted digital ads, social media campaigns, and search engine marketing
- Partner with advocacy groups, community organizations, and local clinics
- Combine digital reach with traditional methods like radio, print, and in-person events
- Pre-screen patients efficiently
- Use online pre-screeners and telephone interviews to assess eligibility quickly
- Streamline referrals to sites for qualified candidates
- Enroll and retain participants with ongoing support
- Provide clear instructions, regular updates, and a dedicated contact person
- Address logistical barriers (transportation, scheduling, childcare)
- Offer retention incentives and foster a positive trial experience
For a deeper dive into this topic, read our article on Challenges in patient recruitment for clinical trials: Navigating the obstacles and finding solutions.
With over 20 years of experience in digital recruitment, Clariness is uniquely positioned to overcome the challenges of clinical trial recruitment. We are dedicated to developing effective, tailored solutions. If you’re seeking support, contact us today.
Global patient recruitment strategies
Reaching patients beyond local borders is key to speeding up enrollment, improving diversity, and helping your clinical trial succeed. Here are some practical strategies for recruiting patients globally:
Leverage multilingual digital platforms
To reach patients worldwide, it’s important to use digital recruitment platforms that support multiple languages and regional nuances. Patient recruitment platforms enable sponsors to connect with potential participants across multiple countries and languages. Clariness’ ClinLife® platform recruits patients across 50+ countries in over 35 languages, breaking down language barriers that often limit global trial reach.
Multilingual platforms allow for culturally appropriate messaging, improving patient understanding and engagement. For example, a trial targeting autoimmune diseases in Europe and Asia can deploy tailored digital ads and educational content in German, French, Mandarin, and Japanese, ensuring patients receive information in their native language, with cultural nuances taken into account. This increases trust and willingness to participate.
Additionally, multilingual platforms facilitate seamless communication between patients, sites, and sponsors, providing real-time updates and support in the patient’s preferred language. This capability is especially important for complex protocols where clear understanding of procedures and consent is critical.
Collaborate with international site networks
Leveraging the network of an SMO to partner with high-performing sites across multiple regions can really boost a sponsor’s global patient recruitment strategy. Established site networks bring valuable local knowledge, existing patient relationships, and proven recruitment capabilities to clinical trial efforts. Sponsors benefit from working with sites that understand regional healthcare systems, regulatory environments, and patient engagement preferences.
To set a study up for success, it’s important for sponsors to work hand-in-hand with sites right from the start. By building recruitment plans together, adapting outreach strategies to fit the local context, and equipping sites with the right tools and training, sponsors can turn sites into real partners – not just participants – in patient recruitment.
Sponsors should also recognize that site capacity, staff experience, and historical recruitment performance vary widely between countries. Selecting the right site partners based on robust feasibility assessments is key to avoiding delays and achieving enrollment goals.
By building strong relationships with international site networks, sponsors can tap into wider patient pools, gain local credibility, and drive faster, more efficient recruitment across global trials.
Consider regional regulations and cultural sensitivities
To recruit patients successfully across different countries, sponsors need to consider more than just logistics – they have to understand and respect each region’s legal, regulatory, and cultural landscape. Rules around consent, advertising, and data protection can vary widely, and getting them wrong can slow down or even derail a study.
Take Europe, for example – GDPR places tight restrictions on how patient data is collected and used. Meanwhile, in countries like Japan and China, there are unique rules about how trials can be advertised and how researchers can communicate with participants. Local ethics committees also have unique expectations that must be incorporated into study creatives and materials and processes.
Beyond regulatory factors, cultural norms influence how patients perceive clinical research. Messaging must be tailored to resonate with local values, healthcare beliefs, and trust levels. In some cultures, involving family members in medical decision-making is standard practice, requiring adjusted consent discussions. In others, stigma around certain diseases may necessitate highly sensitive outreach strategies.
Understanding and respecting these differences is essential for building trust, improving engagement, and ensuring that patient recruitment efforts are both effective and compliant across borders.
Use global patient databases and registries
Leveraging global patient databases, electronic health records (EHRs), and disease registries is a powerful way to identify and engage eligible participants across diverse geographic regions. These resources provide valuable insights into patient demographics, disease prevalence, treatment histories, and potential eligibility based on real-world data.
For example, sponsors conducting oncology trials can partner with international cancer registries to locate patients who meet specific mutation or biomarker criteria. Similarly, global rare disease registries offer access to highly targeted patient populations that may be otherwise difficult to reach through traditional site-based recruitment.
Using patient registry data in recruitment strategies can make a big difference in how quickly and efficiently trials find the right participants. By pre-screening patients through these databases, sponsors can reduce the workload at clinical sites and speed up the enrolment process.
Partnering with registries that allow patients to opt in for trial communications means sponsors can connect directly with people who are already interested. This approach not only widens the recruitment pool and improves targeting – it also helps ensure more diverse and inclusive trial populations, which is especially important for studies that span multiple countries.
Engage local healthcare providers and patient organizations
Local healthcare providers and patient advocacy groups are some of the most trusted voices for patients — and they’re key partners when it comes to global patient recruitment. Working with these organizations helps build awareness, credibility, and interest in your clinical trial among the people you’re trying to reach.
Primary care doctors, specialists, and community clinics already have strong relationships with their patients, making them powerful referral sources. By giving them clear information about your study — like its purpose, who’s eligible, and the potential benefits — you make it easier for them to talk to the right patients about joining.
Patient organizations and advocacy groups also open doors to valuable outreach opportunities. They understand their communities deeply and can help tailor messaging to be culturally relevant, host information sessions, and spread the word through their established networks.
Building strong partnerships with local healthcare providers and patient organizations takes a collaborative, respectful approach. It’s important for sponsors to be transparent, offer real value through education and helpful resources, and make sure all engagement activities meet local regulatory requirements.
When you work within trusted networks like these, you not only raise awareness about your trial – you also help build a positive perception of clinical research in general. And when patients feel informed and supported by people they already trust, recruitment outcomes tend to be much stronger across global markets.
Site selection and its role in patient recruitment
Selecting the right clinical sites is one of the most influential factors in patient recruitment success. Sites with a strong track record, motivated staff, and access to the target patient population consistently outperform others.
Here are some key considerations for site selection and patient recruitment:
Historical performance:
Looking at a site’s past performance can give you a good sense of how well it might do in recruiting patients for your trial. Sites that have consistently hit or even exceeded their enrollment goals tend to know how to find, engage, and support the right participants. A strong track record usually means the site not only has access to the right patient population but also runs efficiently and sticks closely to trial protocols. In fact, a survey of decision-makers in biopharma companies and clinical research organizations found that 84% of them see recruitment-related factors as the most important qualities in a site – and 71% said a site’s recruitment and retention history is the top piece of information they wish they had when choosing where to run a trial.
Patient population density:
The number of eligible patients living near a clinical trial site can make a big difference to how quickly and easily a study recruits. Sites based in areas with a high concentration of potential participants are much more likely to hit their enrollment targets on time. Being close to the site also makes life easier for patients – it means less travel, fewer logistical hurdles, and a better chance they’ll stick with the study. Research into what drives recruitment success backs this up: sites with access to bigger local patient pools consistently see better enrollment rates.
Accessibility:
A site’s physical accessibility plays a big part in patient recruitment and retention. Things like being close to public transport, offering enough parking, and making travel simple really matter when people are deciding whether or not to take part. Sites that are easy to reach tend to draw in more participants – and keep them coming back for follow-up visits too. Making accessibility a priority doesn’t just make life easier for patients; it can also boost enrollment and retention numbers, and help trials run more smoothly overall.
Site engagement:
The energy and experience of a site’s investigators and coordinators can make all the difference when it comes to recruitment. When site staff are truly engaged, they’re more likely to spot potential participants, communicate clearly with them, and stick closely to study protocols. Their commitment also helps create a positive experience for patients, which can boost retention and improve data quality. To get a good sense of how engaged a site’s team really is, it’s worth looking at things like staff turnover, how past collaborations went, and how responsive they are during the feasibility process.
Infrastructure:
A site’s infrastructure – everything from technology and equipment to patient facilities – is also something to consider. Having access to things like electronic health records, diagnostic tools, and comfortable spaces for patient visits makes it much easier to manage data, monitor progress, and meet regulatory requirements. Sites with strong infrastructure are usually better equipped to handle the demands of a clinical trial, helping to speed up recruitment and deliver better overall results.
Using study feasibility assessments can help sponsors identify and prioritize high-potential sites by evaluating their capacity, historical performance, and access to the target patient population.
Once sites are selected, it is essential to ensure they are prepared and positioned to deliver successful outcomes. This involves actively tracking and optimizing key performance indicators (KPIs) such as patient recruitment speed, visit scheduling efficiency, and outreach effectiveness. Monitoring these metrics enables sponsors to address challenges early and support sites in achieving recruitment goals.
For a detailed breakdown of the three most impactful KPIs for clinical trial site success, see The 3 KPIs to Follow for Clinical Trial Site Success.
Overcoming common recruitment challenges
Even with the best planning, many clinical trials still run into challenges when it comes to recruiting patients. It’s a common issue across the industry, and understanding these barriers is key to overcoming them. If you’re interested in a deeper dive, you can explore some real-world insights in this article: The top 3 barriers to Alzheimer’s disease patient recruitment, and how to overcome them.
Here are some of the most common patient recruitment issues and how to address them:
Patient distrust and low awareness:
Many patients are unfamiliar with clinical trials or may be hesitant to participate due to concerns about safety, transparency, or feeling like “test subjects.” Without trust and clear information, recruitment efforts often fall short.
Solution: Launch transparent patient education campaigns, share real-world success stories, and partner with trusted advocacy groups. Use patient engagement resources to build credibility.
Complex protocols and strict eligibility:
Overly complicated protocols and narrow inclusion/exclusion criteria can reduce the pool of eligible participants and discourage interest. Complexity can also overwhelm patients during the decision-making process.
Solution: Simplify inclusion/exclusion criteria where possible, and use adaptive designs to broaden eligibility. Pre-test protocols with patients for clarity.
Logistical barriers:
Long travel distances, inconvenient appointment times, and time-consuming procedures can keep patients from enrolling or remaining in a study. These challenges disproportionately affect diverse and underserved populations.
Solution: Offer flexible scheduling, travel support, and decentralized trial options. Bring study visits closer to home through local labs or telemedicine.
Competing trials:
In regions with a high concentration of clinical research, multiple studies may target the same patient populations, making recruitment more difficult.
Solution: Differentiate your study with clear value propositions, and collaborate with sites to avoid overlapping recruitment pools.
Cultural and language barriers:
Cultural differences and language gaps can lead to misunderstandings, mistrust, or reluctance to participate, especially in global or diverse patient populations.
Solution: Provide multilingual materials and culturally relevant outreach, leveraging global patient recruitment strategies and culturally relevant study creatives.
Digital tools for enhancing recruitment
Digital transformation has completely changed how patient recruitment works in clinical trials – and it’s opened up some exciting new possibilities. Today, a range of digital tools are helping sponsors and sites connect with the right patients faster and more efficiently. Here are some of the most impactful ways technology is making a difference:
Social media advertising:
Platforms like Facebook allow you to target very specific demographics and interests. It’s not just about getting the word out – it’s about reaching the right people at the right time. For example, a Clariness campaign for an atopic dermatitis trial showed that Facebook Ads were the top-performing channel, driving three times more landing page visits than the next best option.
Programmatic advertising:
Using data-driven ad placements across websites and apps helps you reach patients who are actively searching for treatment options, boosting the chances of finding motivated participants.
Patient engagement platforms:
Tools like Clariness’ ClinLife® make it easier for patients to find and connect with matching clinical trials. From raising awareness to pre-screening, these platforms streamline the entire journey and remove many of the common barriers to participation.
Automated follow-ups:
Following up quickly with interested patients is critical to keeping them engaged. One of the key KPIs for clinical recruitment site success is “time to first contact” – and the numbers speak for themselves. Making contact within 24 hours significantly improves the chance of enrollment. In fact, Clariness’ Enrollment Success Team achieves first outreach within 20 minutes in the U.S. and within 1 hour in other regions, showing just how much prompt communication matters.
Telemedicine and remote monitoring:
Decentralized trial models, which allow patients to participate remotely, have made clinical research far more accessible – especially for those living in rural areas or those with mobility challenges. This flexibility is helping more people take part in studies than ever before.
Centralized site support services:
Technology isn’t just about reaching patients; it’s also about supporting sites. Services like the Clariness Site Contact Center act as an extra set of hands for site staff, helping to pre-qualify patients, manage inbound inquiries, and coordinate scheduling. By easing the pressure on site teams, these services help speed up recruitment and create a smoother experience for everyone involved.
Case studies in recruitment success
Below are some of our case studies to illustrate how strategic patient recruitment in clinical trials can deliver measurable results:
Sjögren’s syndrome case study
When a major global sponsor needed help recruiting patients for a clinical trial in Sjögren’s syndrome — a complex autoimmune disease that can be especially tough to recruit for — they realized that relying on traditional, site-based efforts just wasn’t going to be enough. That’s when they partnered with Clariness to create a customized recruitment strategy designed to meet the study’s unique challenges and hit enrollment goals.
Our approach:
- Marketing: Clariness developed a direct-to-patient digital advertising campaign, customized for the USA, France, Germany, and Poland, including a pilot program using both social media and radio outreach.
- Sourcing: We leveraged an existing Sjögren’s syndrome patient database and the Clariness ClinLife® patient portal to identify and engage potential participants.
- Screening: We designed a double pre-screener to reduce screen failures and ensure only eligible patients advanced to site referral.
- Pre-qualification: We utilized our in-house Enrollment Success Team (EST) to pre-qualify patients by phone, address concerns, and support informed participation in local languages.
- Addressing barriers: We created patient-friendly campaign materials based on insights from patient surveys, directly addressing common barriers such as lack of disease awareness, travel restrictions, and concerns about invasive procedures.
Results achieved:
- Contributed 16% of total randomizations for the entire study
- Achieved a 34% cost saving for each randomized patient (projected cost per patient was $76,962; actual cost was $57,256, saving $19,706 per patient)
- Delivered 26 randomizations through Clariness recruitment channels alone
Read the full Sjögren’s case study
Psoriasis case study
For this dermatology study, Clariness teamed up with a major biotechnology company to help recruit patients for a phase II psoriasis clinical trial. The project was ambitious – running over 18 months, across 9 countries, and at 40 different sites. The sponsor needed to find a way to enroll patients as efficiently as possible, all while staying within a tight budget, so they turned to Clariness for support.
Our approach:
- Feasibility strategy: We prioritized regions and sites with the greatest recruitment potential and ROI.
- Marketing: We designed strategically placed digital banner ads that aligned with the demographics of the psoriasis trial population to boost engagement and impact.
- Real-time optimization: We implemented an adaptive advertising approach, starting and stopping campaigns based on real-time feedback from Clariness Enrollment Managers to optimize effectiveness.
Results achieved:
- Contributed over 30% of randomized patients versus the recruitment target, exceeding expectations
- Achieved recruitment goals using just 50% of the available budget, demonstrating significant cost efficiency
- Supported the randomization of more than 600 patients across 40 sites
- Enhanced trial feasibility and ROI through data-driven site selection and adaptive campaign management
This case study highlights how a biotech clinical research organization like Clariness can optimize recruitment strategies for complex clinical trials, balancing budget constraints with high enrollment targets.
Conclusion: Accelerate your recruitment with Clariness
Effective patient recruitment in clinical trials is both an art and a science. By following a structured, step-by-step approach, leveraging global strategies, selecting the right sites, and embracing digital innovation, sponsors can overcome recruitment barriers and deliver successful studies.
Clariness brings over two decades of experience and a global reach to every project. Our tailored patient recruitment strategies in clinical trials are designed to accelerate timelines, improve diversity, and deliver results – no matter the indication or geography.
Looking to accelerate your clinical trial recruitment? Partner with Clariness for innovative and global patient recruitment strategies that deliver results.