Challenges in patient recruitment for clinical trials: Navigating the obstacles and finding solutions

Patient recruitment is a critical component of clinical trials. Yet it remains one of the most difficult challenges in the clinical research landscape.

In this article, we delve into the main hurdles in patient recruitment and explore practical strategies to overcome them. But first, let’s have a look at how these challenges can affect the success of clinical trials.

The impact of recruitment challenges on clinical trials

Patient recruitment barriers can significantly impact medical research, ultimately affecting the success of clinical trials. Below are some of the most common ways patient recruitment challenges impact the research.

Delays in timelines: Patient recruitment difficulties can extend the duration of clinical trials. Our data suggests that clinical trial sites often take an average of 30.5 days to schedule the first patient visit. This can lead to prolonged study timelines and delayed access to critical data.

Inflated costs: The longer it takes to recruit patients, the more resources are consumed. This leads to inflated operational costs associated with extending timelines and increasing outreach efforts.

Compromised trial outcomes: Recruitment challenges can also affect the quality of trial outcomes. Limited patient diversity due to geographic constraints or eligibility restrictions can skew results. This makes it difficult to generalize findings across broader populations.

Understanding patient recruitment challenges is important for making clinical trials more successful. These hurdles can slow down the recruitment process and impact timelines, costs, and the overall quality of the trials.

To tackle these issues, we’ll dive into the key challenges and share some strategies to overcome them.

Key challenges in patient recruitment and the strategies to overcome them

We’ve looked at a range of challenges in patient recruitment for clinical trials. These can be categorized into two categories.

  1. A broad category that touches on patient recruitment barriers in general
  2. A second category tied to clinical recruitment sites specifically and the 3 KPIs to follow for clinical trial site success

Let’s start by looking at the broad category.

Not understanding patient motivations and hesitation

Every indication presents its own recruitment challenges. Not understanding the patient population, including their motivations, fears, and hesitations may be a barrier to joining a clinical trial. Let’s look at recruiting for mental health clinical trials, such as those for Major Depressive Disorder (MDD), for example. These patients often prefer trials with less invasive and less frequent assessments. They also tend to prefer fewer and shorter study procedures.

Furthermore, research indicates that a “fear of embarrassment” often prevents individuals with MDD from participating in studies. They are less likely to participate in trials that may exacerbate their condition or include a placebo, ‘authorized deceptive design’ or ‘post-hoc deceptive design’

Solution: Adopting a patient-centric approach

To address these barriers, it is necessary to adopt a patient-centric approach in both trial design and recruitment strategy. Engaging with patients directly and understanding their preferences can foster greater participation. In our support of a PTSD clinical trial across four sites in Germany, we found that many patients and their families were unaware of PTSD symptoms. By providing more information about how the study could benefit them, we increased awareness and encouraged participation.

Interestingly, motivations for participating in MDD trials differ from other indications where altruism is often the primary incentive. In MDD trials, patients are primarily motivated to find effective treatments for their own condition. By focusing on these motivations through education and support, we can enhance patient engagement and improve recruitment outcomes across various clinical trials.

Lack of awareness

Lack of awareness is a major challenge in patient recruitment for medical trials. Many potential participants are unaware of ongoing trials or do not understand their importance.

A National Institutes of Health article examined several studies that demonstrated how increasing awareness positively influences attitudes toward clinical trials, enrollment, and the perceived benefits of participation (Harris Interactive Survey, 2001).

For example:

Solution: outreach and education

To tackle the patient recruitment barriers that come from a lack of awareness, it’s crucial to roll out strong educational campaigns. Using digital platforms, social media, and community outreach can really help spread the word about ongoing clinical trials and why they matter.

For example, targeted ads and partnerships with local health organizations can boost awareness and encourage more people to get involved. By improving public understanding of clinical trials, we can close the knowledge gap and make sure more individuals are informed and engaged in the research process.

However, it’s important to consider the National Institutes of Health’s recommendations around awareness of clinical research. The ethics of promoting greater awareness of clinical research must be approached with care. Awareness campaigns should focus on encouraging individuals to consider participation rather than pushing for it. Researchers should provide resources that help people make informed decisions about their involvement in research. This can enhance their understanding of the true benefits and risks of participation. This approach also increases awareness of the importance of clinical research overall.

Geographic constraint

Geographic constraints can pose logistical challenges, particularly for trials conducted in specific locations that may not be accessible to all interested patients. For example, rural populations often have limited access to clinical trial sites, resulting in underrepresentation and skewed data.

Solution: Adopting a decentralized trial model

To address the geographic barriers that limit access to clinical trials, decentralized trial models can be considered. Utilizing remote monitoring technologies and telehealth solutions allows researchers to connect with participants who might struggle to travel to traditional trial sites. This strategy not only extends the reach of clinical trials but also makes it easier for individuals in rural or underserved areas to get involved.

Additionally, forming partnerships with local healthcare providers can enhance recruitment efforts. Such collaborations help ensure that diverse populations are represented in clinical research, bridging the gap between potential participants and the opportunities available in clinical trials. By making participation more accessible, we can open doors for many who might otherwise miss out.

Patient diversity

Diversity in clinical trials is one of the key challenges in the recruitment process. Most definitions of diversity in clinical research focus on the “practice or quality of including individuals from various social and ethnic backgrounds, as well as different genders, sexual orientations, and more.” Therefore, recognizing diversity extends beyond simply incorporating a range of racial, ethnic, or multicultural identities. It also encompasses other demographic factors such as sex, age, location of residence, and socioeconomic status. Non-demographic factors like disabilities, comorbidities, genetics, and concurrent medications also factor in.

Despite ongoing efforts to boost participation rates in clinical trials, nearly 80% of these trials face delays or fail due to recruitment issues. Minority populations, especially African Americans, show even lower participation rates. This underrepresentation underscores the urgent need for targeted strategies to address these disparities and promote inclusivity in clinical research.

Solution: Targeted outreach and community collaboration

Increasing access to clinical trials for underrepresented groups is important. One of the ways in which we achieve this is by employing a multilevel approach that connects patients, sponsors, and sites through our ClinLife® patient portal. For example, we actively engaged with Black and African American patients, their communities, and other stakeholders in the clinical trial process, utilizing qualitative and quantitative data-driven outreach methods. This enabled us to connect more Black and African American patients to clinical trials, ensuring their voices were heard and represented in medical research.

Eligibility restriction

Eligibility criteria are important for ensuring participant safety and maintaining study integrity. However, overly strict criteria can create challenges. When eligibility requirements are too stringent, they can exclude certain demographic groups. This narrows the pool of eligible participants.

Solution: A more inclusive approach

Addressing stringent eligibility criteria requires a more flexible and inclusive approach to trial design. This can involve revising inclusion and exclusion criteria to accommodate a broader range of participants while still ensuring scientific integrity.

However, this must be done carefully to maintain scientific rigor and participant safety. Engaging with healthcare professionals and patient advocacy groups can provide valuable insights. These insights could help researchers understand the challenges participants face when considering trial enrollment. In this way, collaboration can refine eligibility criteria to be more patient-centered and increase accessibility.

Additionally, employing clinical trial recruitment solutions such as AI-driven patient matching technology can help identify eligible candidates more efficiently. By streamlining the pre-screening process and providing clear communication about eligibility requirements, we can reduce frustration and increase engagement among potential participants.

Now that we have looked at the general barriers in patient recruitment for clinical trials, let’s examine the challenges of clinical trial site recruitment specifically.

Delayed engagement

One of the most impactful challenges in patient recruitment via clinical sites is the time it takes to engage potential participants. The adage “time is of the essence” is particularly relevant here. A study by Harvard Business Review has shown that following up with a prospect within 24 hours increases the chance of conversion by 60 times compared to any later follow-up.

Solution: expedited first contact

To tackle this, it’s crucial to make the first contact with patients as quickly as possible. At Clariness, we aim to make initial contact within 20 minutes in the US and within one hour globally. This rapid response not only meets patient expectations but also significantly improves patient enrollment. Providing patients with the option to schedule their initial contact at a preferred time further increases the chances of successful outreach.

Taking too long to arrange an appointment

Once initial contact has been made, scheduling the first patient visit is the next critical step. Patients have busy lives, and coordinating a visit can be complex.

On average, recruitment sites take around 30.5 days to schedule the first visit. This can lead to a significant drop-off in interested patients.

Solution: Streamlined Scheduling

To mitigate this, we recommend setting a target of scheduling the first visit within 20 days. Utilizing warm transfer, where patients are immediately connected to site staff after pre-screening, can reduce this time even further. At Clariness, we achieve this by integrating with site calendars to schedule visits directly, resulting in a 40% faster scheduling process.

Poor patient outreach

Reaching patients is not a one-time effort; it often requires multiple attempts. Sites typically make up to three attempts to contact a patient, but this can be insufficient given the busy lives of potential participants.

Solution: Persistent and personalized outreach

At Clariness, we make a minimum of 10 attempts to reach a patient. This persistence, coupled with our tech-powered ClinLife® system, has enabled us to achieve over 90% patient reachability. Understanding patient motivations, such as altruism, can also motivate site staff to make that extra call or send another email reminder.

Different cultures with different preferences

Potential participants are recruited via clinical trial sites across multiple countries and cultures. And each culture has its own set of expectations. For instance, patients in the US expect to be contacted almost immediately, while those in Japan may be more patient – willing to wait as much as a week in some cases. Treating all applications in the same way may negatively impact recruitment results.

Solution: Cultural sensitivity and operational support

To navigate these differences, it’s essential to be culturally sensitive and flexible. Clariness’ enrollment Success Team delivers the first patient outreach within 20 minutes in the US, and 1 hour rest of world. We also reach out in the patient’s native language and adapt our contact times to local preferences.

At Clariness, we bring 20 years of experience in digital recruitment to the table. We’ve dedicated ourselves to understanding the challenges in patient recruitment and finding effective solutions for clinical trials. If you’re looking for assistance, don’t hesitate to reach out to us today.

Leveraging technology for effective recruitment

In today’s digital age, leveraging technology is essential for streamlining patient recruitment processes in clinical trials. Recruitment platforms play a pivotal role. They provide centralized databases where potential participants can be identified and engaged.

For example, platforms like ClinLife® enable researchers to connect with patients efficiently, ensuring that outreach efforts are targeted and effective. AI-driven patient matching tools further enhance this process by analyzing patient data to identify individuals who meet specific eligibility criteria. This significantly reduces the time spent on manual screening. This technology not only speeds up recruitment but also increases the likelihood of finding suitable candidates.

Additionally, targeted digital advertising has emerged as a powerful tool for reaching broader audiences. By utilizing social media and online ads, trial sponsors can engage potential participants where they spend most of their time – online. This approach allows for tailored messaging that resonates with specific demographics, thus improving recruitment rates.

By embracing these technological advancements, clinical trials can overcome traditional barriers and enhance their recruitment strategies, ultimately improving patient enrollment.

For a more in-depth look at overcoming these barriers, read our innovative approaches to patient recruitment for clinical trials article.

Case study: Enhancing women’s participation in clinical trials

Women represent half of the global population, yet their involvement in clinical trials has historically been inadequate, often relegating them to a secondary status in medical research. Our patient recruitment for women’s health conditions case study underscores this with key statistics.

It mentions a review of 86 clinical trials across nine journals that revealed the underrepresentation of women in clinical trials:

Our approach

Recognizing this, Clariness has taken proactive steps to enhance women’s participation in clinical trials. Our Patient Insights team conducts interviews and surveys to identify barriers that women face, such as underdiagnosed health conditions and complex eligibility criteria that often exclude them from participation.

For instance, our recent campaign for a Phase IIb study on symptomatic endometriosis aimed to recruit 318 randomized patients across 51 sites in ten countries. Despite strict inclusion criteria leading to over 70% of pre-qualified referrals failing initial screening, our targeted approach yielded impressive results in improving patient enrollment.

Our recruitment tactics

We implemented an online awareness campaign that included search engine marketing, banner ads on relevant websites, and social media engagement. We generated over 760,000 visits to our ClinLife® website. We also collaborated with patient organizations and created educational content tailored for women. This not only raised awareness but also facilitated engagement.

The results

As a result, we pre-screened over 7,000 patients online, with more than 1,000 referred to the study. Notably, 32% of those referred passed the screening visit, and Clariness contributed to 20% of consented patients.

Through our commitment to understanding and addressing the unique challenges faced by women in clinical trials, we are making strides toward improving representation and health outcomes. By focusing on patient-centric strategies and leveraging technology for effective recruitment, we are not just changing the narrative but actively supporting sponsors in their efforts to include women in clinical research.

Read the full patient recruitment for women’s health conditions case study for more insights.

Conclusion

There are many challenges in patient recruitment for clinical trials, but these obstacles can be overcome. Focusing on the solutions we have discussed, patient recruitment outcomes can be improved to a great extent.

At Clariness, we are committed to accelerating clinical research by delivering innovative solutions that address these challenges. With 20 years of experience, a proven track record of over 25,000 randomizations, and operations in 50+ countries, we are dedicated to helping your clinical trials succeed.

Get in touch

If you face challenges in patient recruitment for your clinical trials, we invite you to explore how Clariness can support you. From patient recruitment and study feasibility to study creatives and materials, our solutions are designed to streamline your clinical trial process and ensure success.

Contact us today to learn more about how we can help you overcome the challenges in patient recruitment and accelerate your clinical trials.