How To Improve Clinical Trial Enrollment Rates

Research can’t move forward without a large, diverse selection of participants. The resulting delays can lead to high costs and may cause study failure or force teams to abandon the research.

Approaching patients early on helps you expand patient access and increase potential participation
A researcher trying to enroll participants for her trial

Table of Contents

  • Common Reasons for Low Enrollment
  • 6 Strategies To Improve Enrollment in Clinical Studies
  • Master the Art of Enrollment

Clinical trials are the backbone of medical advancement. However, finding healthy volunteers and other participants is a challenge. According to a study reviewing cancer clinical trial enrollment statistics, most people view clinical studies favorably, but only about 3 to 5% of eligible adults actually enroll.

Unfortunately, research can’t move forward without a large, diverse selection of participants. The resulting delays can lead to high costs and may cause study failure or force teams to abandon the research.

So, how do you improve enrollment? First, identify the reasons for low enrollment. Then, adopt better strategies to transform your clinical trial recruitment plan and improve participation.

What Are the Common Reasons for Low Enrollment?

Low levels of interest are among the most significant clinical trial enrollment challenges researchers face and occur for several reasons. A review of the potential barriers shows that financial burden, lack of awareness, restrictive eligibility criteria, lack of time, and patient hesitation can all hinder clinical trial patient enrollment and serve as additional, unintended clinical trial registration requirements.

Financial burden is a particularly significant concern, especially for adults with cancer. Treatment often leads to missed work, job loss, high out-of-pocket expenses, copays, and deductibles. While they may consider joining a study, some insurance plans don’t cover clinical trials, leading to higher personal costs. Coupled with the additional time away from work, many patients simply can’t afford to enroll in a trial.

At the same time, many patients aren’t aware that trials that could treat their condition exist. However, even if they are aware, many are not considered. Studies (including observational studies) often exclude historically underrepresented populations, sometimes including ethnic minority representatives, which means some of those who may otherwise be eligible don’t get the opportunity to enroll.

6 Strategies To Improve Enrollment in Clinical Research Studies

Adopting clinical trial recruitment strategies may help address some of these low enrollment issues. Changing eligibility criteria, hiring an enrollment team, leveraging technology, and connecting with patients early on may improve recruitment and participation.

1. Review Inclusion and Exclusion Criteria

For valid study results, clinical trial participants should represent and reflect the patients who will use the medication or device. Restrictive eligibility criteria may affect your results and skew your understanding of risks vs. benefits. This also dismisses many potential participants.

Unfortunately, these restrictions often affect underrepresented and underserved populations. However, patients who belong to ethnic minorities can be just as likely as others to enroll in clinical studies. Of course, not every patient will have the condition and specific disease characteristics you’re looking for, but reviewing criteria to ensure your trial participants represent the general population can improve enrollment.

Older adults, for example, are often excluded from studies for drugs intended for older adults. Updating the upper age limit of exclusion criteria could open opportunities to additional patients and promote clinical trial participation.

2. Approach Eligible Patients Early

Disease-related factors are standard exclusion criteria, but broad criteria limit potential patients who can enroll. One effective strategy is to connect with patients at risk of or in the early stages of a disease. The goal is to find volunteers who meet the criteria but aren’t critically ill, which may affect study outcomes.

Setting cancer clinical inclusion criteria to include those in the early stages of cancer, for example, opens the population to include more patients. You might also incorporate patients with prediabetes for a type 2 diabetes study, for example. Approaching patients early on helps you expand patient access and increase potential participation.

3. Do a Systematic Review and Address Potential Barriers

A systematic review of similar or previous research identifies common concerns in trial design, protocols, criteria, or other factors that affect enrollment. As in any scientific process, the goal is not to make assumptions but to identify patterns based on data.

The review team should include multiple experts for a well-rounded perspective and to reduce the risk of errors or bias. Once you identify concerns, you can use insights to address potential barriers in your protocol design and eligibility criteria.

4. Share Previous Trials’ Success Stories

Social proof is a powerful behavioral motivator. People highly value their peers’ opinions and experiences, and positive experiences can encourage trust and patient enrollment in clinical trials. If you want to encourage participation, you could discuss other doctors recommending the study or the number of similar patients who’ve decided to participate and their outcomes.

However, ethics and regulations mandate that patients enroll voluntarily, so you must convey risks and requirements during the informed consent process. Use detailed informed consent forms and be clear about potential side effects, expectations, and time costs.

5. Hire a Specialized Task Force To Meet Enrollment Goals

A specialized task force is a team focused entirely on the clinical trial enrollment process. The most effective team has dedicated resources to apply directly to trial enrollment and can coordinate multiple trials simultaneously.

The task force might use several methods to recruit and retain patients, including recruitment management systems. Central tools that link electronic health records can help identify potentially eligible patients, and you can connect with physicians to organize participation.

With dedicated teams and resources solely geared for enrollment, you gain a streamlined process that improves efficiency. Researchers are also then free to focus on other vital work.

6. Leverage Technology To Reach a Wider Patient Population

Decentralized clinical trials are another way to engage patients. The ability to carry out some trial requirements at home, in other locations, or through virtual methods gives patients more flexibility and reduces challenges like travel costs and missed work.

However, data collection and monitoring is still vital. Technology (such as wearable devices, biometric sensors, remote monitoring, and telemedicine) can help track and engage patients. Designing a trial that optimizes modern technology and clinical trial recruitment tools may help you reach a wider population.

Keeping enrolled patients engaged is also important. Patient dropout rates vary from as much as 30 to 50% and occur for many reasons, including a lack of social support. An intelligent workspace where you can connect remotely with trial participants can encourage engagement and may help patients stay enrolled throughout the trial.

Implement Automated Outreach To Master the Art of Enrollment

Clinical trial patient recruitment and enrollment is vital to your research success, yet the process is often complex and challenging. Currently, research teams are incorporating modern technology into the enrollment workflow to combat these issues, leveraging automation for easier operations.

One of these tools is automated communication software, such as Studypages. Using a microsite, you can attract online clinical trial discovery and motivate volunteers to enroll. Then, you can track participants and engage based on a set of rules and even attend to your data collection needs all in one place.

Seamlessly collaborate with teams, communicate with patients, and foster engagement.

Learn more today.