Recruiting patients for drug studies

Drug trials are important for improving medical knowledge. Recruiting patients for these studies is a key part of clinical research. Effective recruitment strategies enhance the trial data quality and help ensure that studies are completed on time and within budget.

This article will cover the most effective ways to recruit patients. It will also look at common challenges in this process. Finally, it will share some new ideas to make recruitment easier and keep patients involved during the trial. But first, let’s examine why having an effective recruitment process is so important.

The importance of patient recruitment in drug studies

Getting patients on board is crucial for bringing new therapies to market. Slow enrollment can lead to several challenges, including extended trial durations, increased costs, and potential damage to your reputation among investors and healthcare providers.

On top of that, effective patient recruitment helps ensure you have a diverse group of participants. This diversity allows researchers to collect comprehensive data that reflects different demographics and health conditions. In fact, successful patient recruitment is closely linked to the quality and validity of clinical trial results.

To highlight just how important patient recruitment is, we’ve pulled together some statistics from a research paper by the Journal of Biosciences and Medicines:

Common challenges in recruiting patients

Taking the above statistics into account, it’s clear to see that there are many challenges in patient recruitment for clinical trials[1] . Below are some of the key ones.

Low awareness

Low awareness among both patients and physicians presents a barrier to recruiting for medical trials.

For participants:

A lot of potential participants just aren’t aware of clinical trials or how the clinical trial process works. They might not fully understand the benefits and risks involved. This often comes down to a lack of accessible education about clinical trials.

Because of this knowledge gap, misconceptions can arise about what participating really means, which makes it even harder to engage patients in clinical research.

For physicians:

According to clinical research, the National Cancer Institute reported that many physicians are not fully aware of available clinical trials. Some may not know about local resources, while others might assume that no trials are suitable for their patients.

Misconceptions and fears

According to clinical research, the fear of being a “guinea pig” is a common misconception contributing to low enrollment rates. Many potential participants feel anxious about joining experimental treatments, fearing they might not receive adequate care or could be subjected to unsafe procedures without proper oversight. This anxiety often stems from a lack of understanding about how clinical trials work and the safeguards that are in place to protect them.

Some patients also worry about being assigned to a placebo-controlled group instead of receiving active treatment. They fear they might miss out on the best available care and treatment options.

Research from the National Library of Medicine shows that many people experience what’s called a therapeutic misconception. This is when they mistakenly believe that participating in a clinical trial means they’ll get standard medical care instead of being part of a study designed to generate new knowledge. This misunderstanding can create confusion about the risks and benefits of participation and therefore undermine informed consent and ultimately lead to lower enrollment rates in clinical studies.

The feeling of losing control over patients’ care

Research shows that unwillingness to “lose control” over a patient’s care is a concern for many physicians. Doctors often view their relationships with patients as crucial to providing effective treatment. They genuinely want what is best for their patients.

When a referral to another facility is necessary for trial participation, they worry about losing oversight of the patient’s care. This fear can lead to reluctance to recommend clinical trials. They may feel that they cannot ensure the same level of support and continuity that they provide in their own practice.

Lack of trust between primary care providers and patient

According to a study by the Kaiser Family Foundation, as referenced in a research paper, a significant percentage of millennials lack a consistent primary care provider. The absence of a trusted relationship between primary care providers and patients can hinder clinical trial recruitment. This is because primary care providers are often viewed as the most reliable source for information about clinical trials. Patients may therefore be less likely to consider participating in clinical research without a strong connection to a physician.

Strict eligibility criteria

While necessary for safety and validity, stringent inclusion and exclusion criteria can reduce the pool of eligible candidates. As the drug development process evolves, clinical trial designs have become much more complex. This is due to the need to address challenging and recurring health conditions that currently lack effective treatment options. As a result, eligibility criteria are becoming more specific and stringent.

Research has shown that stringent protocol eligibility criteria can hurt patient recruitment. For instance, a narrow range of specific screening lab results can result in 59% of screen failures in interventional studies compared to observational studies. Another study revealed 81% of respondents rated drug study eligibility as the most noteworthy barrier when it comes to patient recruitment.

Logistical constraints

Patients who face logistical difficulties in attending appointments may miss site visits. According to a study by the National Institute of Health, approximately 3.6 million Americans miss medical appointments annually due to transportation issues. These barriers are more likely to affect older individuals, females, minorities and those with a lower income.

This barrier extends into clinical trials. Joining clinical trials usually requires patients to frequently visit trial sites. This can be a real challenge for those who live far away from site locations or don’t have reliable transportation.

The burden of travel can result in frustration and dissatisfaction, as patients struggle to reschedule missed appointments and maintain consistent participation in their treatment plans.

Competing trials

Competing trials is another challenge in patient recruitment. This is especially problematic when multiple studies are attempting to enroll participants from the same patient population. This scenario often leads to increased competition for a limited pool of eligible patients, making it difficult to secure enough participants for any single trial.

Research indicates that when several clinical trials compete for the same group of patients, it can result in lower enrollment rates. Heightened competition is linked to increased recruitment shortfalls as potential participants may feel overwhelmed by the choices. They may find it difficult to prioritize one study over another based on perceived benefits or how familiar they are with the research team.

Can you relate to some of these challenges? At Clariness, we have 20 years of experience in digital recruitment. We have dedicated ourselves to understanding these challenges and finding effective clinical trial recruitment solutions. If you need assistance, contact us today.

Effective patient recruitment methods

To boost your efforts in recruiting patients for drug studies, consider implementing the following strategies:

Raise awareness and address misconceptions through education:

One of the most effective patient recruitment methods of enhancing public awareness and addressing misconceptions is through targeted educational campaigns.

The following actionable steps can help bridge the knowledge gap:

Foster collaboration between primary care providers and trial sites

It is advisable to establish clear communication channels and support systems that can help physicians feel more comfortable referring patients to trials without losing oversight. This can help enable the continuity of care.

Broaden eligibility criteria

A report by Applied Clinical Trials suggests that overly narrow eligibility criteria significantly limit recruitment potential. Adjusting these criteria where possible can help enroll a more representative population, thereby enhancing the validity of trial results. This can be achieved by reevaluating inclusion/exclusion criteria to ensure they are necessary for participant safety and relevant to the research question.

Simplify the enrollment process:

Streamlining the recruitment process is essential for enhancing patient enrollment in clinical trials. One effective solution is to implement electronic enrollment systems that incorporate online pre-screening questionnaires and easy scheduling options. These systems can significantly reduce barriers to participation by making the enrollment process more user-friendly and accessible.

Provide transportation:

Innovative solutions are being explored to mitigate transportation barriers. For instance, some clinical research organizations have partnered with ride-sharing services like Uber Health to provide free transportation for trial participants. This helps to reduce the burden of travel costs and improves overall patient experience.

By addressing these logistical challenges, clinical trials can enhance patient recruitment and retention, ultimately leading to more successful outcomes in research efforts.

Leveraging technology in patient recruitment

Technology can be a powerful tool in your patient recruitment strategy. AI-driven tools can analyze data to identify potential participants based on specific criteria. Patient registries help maintain a database of individuals interested in clinical trials.

Digital advertising platforms also allow for broader outreach. It makes it easier to connect with patients who may not be aware of ongoing studies. For example, targeted digital advertising can direct users to a dedicated website with comprehensive information about trials.

How technology can enhance recruitment and clinical trial patient engagement

Clariness offers innovative solutions that align perfectly with this approach. Our proprietary ClinLife® platform is designed to enhance patient recruitment through a streamlined enrollment process. Our technology facilitates online pre-screening and scheduling, making it easier for patients to participate in clinical trials.

We explore this topic in greater depth in the article: Innovative approaches to patient recruitment for clinical trials.

Best practices for maintaining clinical trial patient engagement

Keeping patients engaged throughout a drug study is essential. Here are some strategies to maintain clinical trial patient engagement:

Maintain clear and consistent communication

Effective communication is foundational to patient engagement. Keeping participants informed about updates, study progress or protocols, expectations, and updates fosters a sense of involvement and trust. Regular check-ins through emails, phone calls, or text messages can help keep the communication channels open and address any concerns participants may have.

Utilize technology for convenience

Incorporating technology into the trial process can significantly enhance patient engagement. Tools such as mobile apps, telemedicine, and wearables allow patients to participate more conveniently from their homes.

These technologies have many benefits:

Personalize patient communication

When patients feel as if they are spoken to on a one-on-one level, they are more likely to engage. This is why it’s important to understand each patient’s circumstances, preferences, and motivations. Tailoring communication based on personal information allows researchers to provide relevant information and support that resonates with participants.

Seek patient feedback

Actively soliciting feedback from participants about their experiences can provide valuable insights into how to improve engagement strategies. Surveys or focus groups can help identify pain points in the trial process. This can enable the refinement of communications and resources accordingly.

Create a supportive environment

Building a therapeutic alliance between patients and the care team is essential for fostering engagement. This involves demonstrating empathy, understanding patient concerns, and ensuring that participants feel valued throughout the trial process.

Address barriers to participation

Understanding common barriers that patients face can help researchers design more inclusive trials. Providing solutions like transportation assistance or simplifying enrollment processes can enhance participation rates.

Case studies: Doubling patient enrollment in a migraine study

Overview

In a recent Phase II migraine study for a large medical device company, we successfully doubled the patient enrollment rate. The study focused on patients suffering from migraine with aura and those with a patent foramen ovale (PFO). The initial project contract covered a 6-month period and aimed to support enrollment at 20 sites across Canada, Germany, Switzerland, and the UK. However, the study faced significant challenges due to the rare patient population defined by the protocol criteria, leading to a high pre-screen failure rate.

Our approach

To tackle these challenges, we implemented a multi-faceted strategy:

Awareness campaign: We launched a comprehensive awareness campaign that included:

This approach was designed to reach potential participants across various platforms and raise awareness about the clinical trial.

Two-level patient pre-qualification process: We established an efficient two-level pre-qualification process that involved both online and phone-based screening. This allowed us to quickly identify eligible candidates while minimizing unnecessary visits to trial sites.

Site support activities: To optimize resource use at trial sites, we provided site support activities, including a dedicated helpdesk. This ensured that site staff could efficiently manage inquiries and streamline the enrollment process.

Additional trial sites: As the project progressed, the sponsor recognized the need for more recruitment capacity and enlisted our services to select additional trial sites. This strategic expansion helped accommodate more patients and increase overall enrollment.

Results

Our migraine drug study enrollment efforts yielded remarkable results:

Conclusion

Strategic patient recruitment is essential for the success of drug studies. In this, it’s important to understand common challenges and employ effective recruitment methods, best practices, and technology. By doing this, clinical trial organizations can enhance enrollment rates and ensure robust data collection.