Patient retention in clinical trials is one of the largest challenges facing sites, sponsors, and CROs. The Center for Information and Study on Clinical Research Participation found that 23% of participants who enroll in a study don’t complete it.
When a participant drops out of a study, the time spent identifying, consenting, screening, and enrolling them is wasted. The average trial already faces delays of 1-6 months because of recruitment shortages. Losing one-quarter of the patients who actually enrolled can cause trial timelines to stretch out even longer and can cost sponsors $600,000-$8 million per day.
If the industry truly wants to make clinical trials more efficient, we need to think about how to increase participant retention. To do that, we should listen to the most common reasons patients drop out of trials, like:
- Inconvenient study visits
- Lack of belief in the trial’s benefits
- The feeling that they are undervalued or unimportant
Then, we must address these concerns with patient-centric study design and conduct. Here’s how.
More Convenient Study Visits
When patients were asked why they dropped out of clinical trials, one of the top answers was the study center’s location.
Another survey asked all clinical trial participants–both those who dropped out and those who finished the trial–what parts of a trial were most burdensome. The top three responses were:
- Traveling to the study clinic (44%)
- Diagnostic tests (42%)
- The length of study visits (40%)
These statistics make it clear that traveling long distances for time-consuming study visits can be very disruptive to patients’ lives, especially if they work strict hours, are caregivers, or don’t have access to a car.
Depending on protocols, it may not be possible to remove diagnostic tests or make visits shorter. But sponsors, CROs, and sites can increase patient retention in clinical trials by using decentralized methods to let patients participate from home or a closer location.
The industry can make study visits more convenient by:
- Embracing patient-facing technology
- Scheduling home visits
- Holding trials at frontier sites like doctors’ offices, labs and pharmacies
Each of these strategies appeals to different types of patients, so it’s important to consult with patient advocates before a study begins to determine which techniques may help them most.
The Benefits of Patient-facing Technology
During a session at the 2022 Research Revolution conference called “Selecting Patient-facing Technology That Actually Works,” patient advocate and clinical trial participant Gunnar Esiason spoke of the challenge of traveling hours for each of his study visits while seriously ill.
Technology can alleviate this burden by allowing patients to submit study data from home and travel to the site less often. When asked whether they would be willing to use technology during a trial:
- 86% of patients were comfortable using a computer to enter study data
- 85% were comfortable using a wearable device
- 84% were comfortable with video conferencing
- 79% were comfortable using an app on their smartphone to enter study data
These numbers suggest that the majority of patients are open to the idea of technology if it’s intuitive and allows them to travel less. And when nearly half of patients find traveling to the study clinic “very burdensome,” cutting back on even a few visits can make a difference for patient retention in clinical trials.
For more on how research sites can help patients use clinical trial technology, you can check out our guide to patient engagement tech.
But some patients are uncomfortable with tech, and others don’t have WiFi access at home. For those patients, home visits or visits to community sites can prove more convenient.
Scheduling Home Visits
90% of participants said having choices for where they do their study visits was somewhat or very important to them. And when participants who completed the trial were asked what features were most convenient for them, participants gave “having study visits with flexible times” as one of their top three answers.
Home health services are one way to make study visits more flexible and give patients choices. Not every patient will want a nurse to visit their home–but for patients who are older, patients with disabilities, or patients who are caregivers, home health can be far more convenient than constant site visits.
Dr. Christina Brennan, a keynote speaker at Research Revolution 2022, pointed out that hospitals and health systems often already have home health services within their networks. This makes it easier to deploy these services during a clinical trial.
While some patients welcome home health care, others may want to maintain their privacy and not have nurses in their home. This is where community sites can help increase patient retention in clinical trials.
The Potential of Frontier Sites
Frontier or community sites are sites like local doctors’ offices, labs, clinics, and pharmacies. These locations are often closer to where patients live than the main study site, and patients who rely on public transportation, work strict hours, or take care of children may be able to reach them more easily.
When asked where they be willing or very willing to have study visits:
- 87% of patients said yes to their primary care doctor’s office
- 86% said yes to a lab
- 84% said yes to a local community health clinic
- 76% said yes to a pharmacy
Many people–about 84%–were also willing to go to a hospital or major academic medical center (AMC). But this can depend on how close the patient lives. Only 30% of people live within 2 hours of a major AMC.
That means primary care doctors, labs and community health clinics can all be excellent alternatives for patients who live further away from an AMC. Offering patients a variety of options for site visits, where possible, could lessen the burden of travel and help studies retain patients.
Strengthening Patients’ Belief in the Trial’s Benefits
One U.S. study found that 43% of patients dropped out of trials because they believed the investigational intervention was not effective. This is a common fear: in a U.K. study, 37% of patients wouldn’t join a trial because they would rather receive the standard treatment, and 31% because they were afraid of receiving a placebo.
These fears are difficult to overcome, because there will always be clinical trials where the investigational treatment doesn’t work or where the patient receives a placebo.
If clinical research teams want to improve patient retention during clinical trials, they need to communicate clearly and set realistic expectations from the moment participants join a trial.
When asked how well they understood trials, only 31% of participants said they understood them very well. By better explaining the trial early in the process, clinical research sites may be able to avoid patients dropping out later on.
Clinical Research Coordinators, nurses, or principal investigators should address patient concerns like:
- What are the known side effects? (if any are already known)
- What happens if I have unanticipated side effects?
- What risks come with joining a clinical study?
- What are the potential benefits of this study? (for me or for others with my disease)
- Would a standard treatment be effective for me?
Once patients have clear, understandable, and honest answers to these questions, they can make a more educated decision about whether to join the trial.
How Participants Can Help Other Patients
The good news about participant recruitment and retention? Personal benefit isn’t the only reason patients join trials.
- 50% of clinical trial participants said they wanted to advance the science and treatment of their disease/condition
- 50% wanted to save or improve the lives of other patients with their disease/condition
Some participants may still decide the trial isn’t for them or the side effects of the treatment are too difficult to cope with. But if patients understand that the trial may advance the treatment of their disease, even if it doesn’t help them personally, they may be more likely to stay involved.
Participant Engagement and Regular Updates
Sites, CROs, and sponsors can increase patient retention in clinical trials by sending them regular updates on the study’s progress.
When asked why they remained in a trial, the number-one reason participants gave was “feeling the benefits of the study drug.” The number-two reason? “Being informed of clinical research progress on a regular basis.”
Sending participants an update on how the trial is going via email or text is a simple gesture, but it can make a large difference. During one trial, the researchers emailed a one-page study update to some participants and didn’t send an update to the others. Participants who received the update were 35% more likely to complete their study tasks afterward.
89% of participants also said they would like to receive the results of their clinical research study in plain, easy-to-understand language.
Participants crave communication and information about how they’ve helped other patients. If they have that information, they are more likely to stay in a trial, even without immediate personal benefit.
To learn more about the importance of staying connected with clinical trial participants, check out the article “How Digital Connections Can Create a Positive Patient Experience in Clinical Trials.”
Participants Should Feel Valued and Included
If the clinical research industry wants to improve patient retention in clinical trials, we need to treat patients like partners. A UK survey showed that almost one-fourth of clinical trial participants still fear being treated like guinea pigs.
The fear of mistreatment is especially strong among Black patients, with 47% expressing concern about past events where trial participants were abused. Although the clinical trial industry now has strong participant protections in place, those protections don’t erase the mistreatment of the past.
This is why it’s so critical to make participants feel valued, included, and important during clinical trials.
Sponsors and CROs should include feedback from patient advocates when designing trials. During the recruitment phase, clinical research staff should answer patients’ questions, listen to their ideas, and explain the informed consent document in easy-to-understand language.
Strategies to Help Participants Feel Valued
Throughout the trial, patients crave frequent communication and updates from clinical research staff. Sites that had 80% or better patient retention used strategies like:
- Ensuring staff are well-trained, organized, persistent, and communicate well
- Adding “personal touches” to visits and communication
- Treating the participant with respect
- Being considerate of the patient’s time
- Identifying challenges the participant is facing and helping the participant address them
At the Research Revolution session “Career Planning in Clinical Research,” Susan Landis of ACRP emphasized that DEI training for clinical research staff is critical. This training can help clinical research professionals avoid unconscious bias when interacting with participants.
Diverse site staff and patient populations also contribute to patients feeling safe and included. 73% of clinical trial participants said a diverse patient population was somewhat or very important to them, and a Tufts study found that sites with diverse staff tend to attract more diverse patients.
You can learn more about how traditional and community-based sites can improve patient diversity here.
The key takeaway? Participants need to feel like people, not subjects. Research sites must listen to them, keep them informed, help them overcome challenges, and respect them and their unique backgrounds. When participants feel heard and respected, they are less likely to drop out of studies or stop following protocols.
The Secrets of Patient Retention in Clinical Trials
Increasing patient retention in clinical trials reduces study timelines, saves sponsors money, and helps new treatments get to market faster.
Some patients will always need to drop out of a trial: because they have an adverse reaction to the treatment, because the side effects are too strong, or because their life doesn’t permit participation anymore.
But if clinical research teams offer patients more convenient study visits, share accurate information about trials’ risks and benefits, and make participants feel included and respected, they can improve patient retention in clinical trials. And in the process, clinical research professionals will give better care to the patients they serve.
For more on patient engagement and the patient experience, see our webinar Going Digital: Patient Engagement and Your Consent Workflow or the article 5 Facts You Should Know about Patient-facing Technology.