The Clinical Trial Patient Recruitment and Retention Handbook


Recruitment and retention of patients are one of the largest barriers standing in the way of successful clinical trials. 75 percent of clinics fail to enroll their target number of subjects; 15 to 40% of patients enrolled at the beginning of the study drop out later on. These two areas also account for a lion’s share of clinical trial costs, staff time, and are key predictors for future sponsor awards. So while there might be more patients available to recruit than ever before, understanding how to engage them, retain them and maintain organized and integrated systems for recruitment and retention are critical to success. Understanding how your site is performing in both of these areas — and identifying new ways to conquer both — should be a priority for any research team.

Challenges of Recruitment and Retention


Whether there are no trials available close to the patient’s location, the patient is not eligible, they never heard about a trial, or they aren’t satisfied with their experience while in a trial, the barriers to patient enrollment and retention are two of the key challenges for overall clinical trial success. Some underlying causes for these challenges include:

  • Not having a diverse and well trained staff that can address various trial participant concerns and understand how to mitigate both prospect and patient barriers
  • Not implementing the right tools to ensure study compliance, patient accuracy, and trial tracking. This attention to detail is possible through CTMS software, which allows staff to better manage every process in the trials under management. 
  • Lack of outreach tools that can both attract participants and keep them engaged throughout the trial

Benefits of a CTMS for Patient Recruitment


Recruiting with a CTMS allows you to track your metrics and base decisions on what’s working and what’s not. It also helps manage and nurture subjects, allowing organizations to manage participants in one centralized location. You can also use a CTMS to create milestone enrollment goals and check enrollment progress for all studies at your site. This allows you to focus on and prioritize recruitment efforts. Tracking your recruitment efforts and outcomes can play a strategic role in deciding the best strategies for how to recruit for future studies. CTMS integrations with social media can also help make recruitment efforts more efficient while simultaneously increasing data accuracy. See how Clinilabs Reduces Prospect Outreach Time by 85%

Benefits of CTMS of Patient Retention

Patient using Tablet

At its core, retention is based on positive, proactive, and valuable engagement with patients. When patients feel that they’re more than just a number and are empowered to be an active part of the trial, there’s a better chance they’ll stay on for the entire length of the research. Selecting the right CTMS functionality  – that is, one focused on enabling interaction and engagement – can improve retention efforts. For instance, look for a system that incorporates HIPPA-compliant, two-way text messaging. This advancement allows staff to connect and chat with patients, confirm appointments, send reminders, address patient questions, and inform them of changes or upcoming payments. Retention will improve when patients know that they have the ability to securely reach out to your team at any time.

Best Practices for Low-Budget Patient Recruitment Advertising Campaigns

Working within a low budget for your next Patient Recruitment :

  • Optimizing user of advertising funds through creative solutions
    • Have a plan that is easy to understand and follow
  • Requesting additional funds for specific advertising avenues
    • Advertising strategies that worked well or promising new leads
  • Tracking and following up with referrals from different media sources
    • Maximizing ROI on advertising techniques
  • Developing and utilizing own patient database
    • Collecting potential information
    • Email blast tutorial

Tactics to maximize ROI

  • Creating new landing page for every advertising patient recruitment campaign
    • Takes potential patients to relevant information quickly and efficiently
    • Simplifies tracking patient referral sources to identify successful/unsuccesful marketing tactics
  • Make landing pages mobile friendly
    • 8 out of 10 internet users accessed the web regularly on a smartphone 

Diversity : Increasing Clinical Trial Patient Diversity

Attracting a diverse population of patients for a clinical trial is critical for patient health and long-term community wellness. A drug may impact different demographics—by age, race, gender and other factors—in vastly different ways. Therefore, trials need to draw in a similarly diverse group of patients to ensure the drug’s effectiveness. While attracting diversity in a patient population may be a difficult hurdle, the success of any clinical trial depends on how well you clear it. However, the industry is falling short. Recent studies show that while African Americans comprise 20% of multiple myeloma patients in the US and are about two times as likely as white Americans to receive a diagnosis, they make up merely 4.5% of clinical trials conducted since 2003.

Analytics : Realizing Real Recruitment & Retention Results – Data Points

Data is an invaluable tool in the clinical trial toolbox—especially when it comes to tracking and showcasing your site’s recruitment and retention results. Accurate and current data demonstrates to potential and current sponsors that your organization is capable of effectively organizing and running a successful trial to deliver the results they need. Key metrics for recruitment and retention include patients available, screened, enrolled, completed, failed screenings, and dropped out along with overall enrollment and retention rates.

Tools : Facebook, Text, and eClinical Solutions for Recruitment and Retention

Utilizing improved systems and tools are necessary in the ever-changing clinical trial landscape. eConsent can help efficiently manage patient recruitment, retention, and increase ROI. Social media is increasingly becoming the driver of new patient recruits and CTMS-enabled texting helps sites more fully engage with patients at the click of a button. eConsent is another tool that can have a significant impact on clinical research trial recruitment and retention. The average retention, from patient identification to study completion, averages only 7% industry-wide. However, 72% of patients that don’t complete the study are a result of refusal to comply or misunderstood patient expectations, two of the key challenges eConsent can help prevent.  Through earlier and more comprehensive patient engagement, the risk of dropout decreases, ensuring higher retention rates to deliver to sponsors.  

The Role of Caregivers in Patient Recruitment and Retention

Patients are the lifeblood of clinical research trial work and should be the focus. However, given the demographic shift to an older community, the increase in remote trials, and a push for more diverse trial participants, sites shouldn’t ignore the role of caregivers in the process. Incorporating caregivers, whether it’s a family member or home health provider, as a key stakeholder in clinical trial work reduces patient burden and maximizes opportunities for success. Optimizing this group’s positive influence and establishing successful trials necessitates strong CTMS. Caregivers can be integral – or detrimental – in disease treatment research and should be engaged as fully as appropriate given the patient’s needs. 

Patient Location : Geographically dispersed

There is one piece of clinical trial participant data that has long been an enormous concern for research leadership – 70% of potential clinical trial patients live more than two hours from a site. This constraint has challenged recruitment and retention efforts for clinical research sites of all sizes and in all areas of the nation. However, increased site capabilities for and sponsor support of decentralized clinical trials (DCTs) mitigates the most common participant hurdle – location.  With physical distance challenges lifted, DCTs increase the pool of candidates and the number of qualified trial participants, no matter where an actual site is located.

Additional Patient Recruitment & Retention Resources

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