Recruiting and enrolling patients in clinical trials can be a long and costly process. Finding the optimal candidates and then prompting them to enlist can take months or even years. According to the MD Group, it costs approximately $6,533 for just a single patient’s enrollment to a clinical study.
But that’s only half of the work.
Once a patient has signed up, retention rates can waver. Most trials will plan for a 30% patient drop-out rate. But that rate can go much higher, especially if you fail to plan your clinical trial properly.
To help you address these challenges, we’ll provide six tips on how you can enhance your clinical trial recruitment and retention plan.
#1 Leverage technology for recruitment
Participation starts with awareness. If you want people to sign up, you need to inform the public of your clinical trial design, its start date, and its terms and conditions. According to the NIH:
- 85% of patients were either unaware or unsure that participation in a clinical trial was an option at the time of diagnosis.
- 75% of these patients said they would have been willing to enroll had they known it was possible.
- 32% of American adults indicate they would be very willing to participate in a (cancer) clinical trial if asked.
- 28% indicated they would consider it, but hold some reservations.
If you want to succeed at recruiting, you must spread the word. The more people you reach, the better your odds are of finding qualified candidates.
Today, there are dozens of mediums you can leverage to perform patient or subject recruitment outreach. Depending on your ideal trial participant persona, one outlet may be more effective than another. For instance, you can use:
- Traditional media – Mass communication channels like television, radio, and newspapers can play recruiting advertisements.
- Social media – Leveraging social networking channels like Facebook, Instagram, Twitter, and TikTok is useful, particularly if you are targeting younger demographics.
- Website – You should create a customized website that provides all of the relevant details about the clinical trial and a place to sign up.
- Healthcare Cost and Utilization Project (HCUP) databases – These types of databases contain detailed information about hospitals and doctors that treat a specific set of patients.
- Advocacy groups – By partnering with advocacy groups that share mutual interests, you can foster word-of-mouth marketing.
If you’re interested in finding out more strategies on how patients are recruited for clinical trials, our resource center can help you get the tools you need to find participants for your trial.
#2 Instill trust
Trust forms the foundation of both recruitment and retention in clinical trials. Lack of public trust and confidence in public health institutions is prevalent across the country. According to The Hill:
“Nearly half of Americans do not have high trust in the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA) or other major public health organizations when it comes to recommendations they make to improve health.”
The public also carries a level of distrust in life science companies, with a significant minority of Americans viewing pharma companies unfavorably. Many of those do not trust companies to provide reliable information about adverse drug effects and safety. Unfortunately, this mistrust can affect patient recruitment and retention for clinical trials.
Here, clinical trial designers must work closely with physicians—doctors who have already established that trust—to inform patients about the clinical trial, provide reassurance about the process, and encourage them to consider enlisting.
#3 Create transparency
If you want to instill trust and retain patients throughout the entire clinical process, you must provide patients with a detailed agenda of what the trial will involve and what’s expected of trial participants:
- What are the requirements?
- Do patients need to travel to the facility? How often?
- How long will the trial last?
- Do participants need to refrain from alcohol or sex?
Trial participation can be lengthy and may also require participants to make real-world sacrifices of their time, money, and energy. Failure to properly educate them about what they’re signing up for is one of the quickest ways you can break their trust and decrease retention.
Your outreach materials should be completely transparent about what the trial will involve. Doing so may reduce the total number of potential volunteer candidates, but it will ensure that the group you end up with comprises eager participants equipped with a clear understanding of what to expect. Transparency on materials and processes are effective patient retention strategies to ensure you have the ideal number of candidates to succeed.
In addition to clearly defining what participation will entail throughout the entire clinical journey within outreach and consent materials, you should also outline what you hope to achieve. You must convince participants that their sacrifices will matter—that they’ll make a positive impact.
Without that reasoning, there’s little incentive to keep going, especially if the process is challenging.
#4 Make it patient-centric
A central design flaw that derails many clinical trials is that it lacks patient-centricity. Too often, trial designers put the horse before the cart by basing the recruitment process on the disease rather than the individual patient.
When a trial lacks real-world relevance and significance to patients, simply convincing them to enroll is challenging enough. But retaining volunteers throughout the entire duration of the trial becomes an even more difficult feat should the process fail to address the patient’s needs or produce relevant outcomes.
A properly designed, patient-centric trial will include the patient’s voice from the outset—not treat it as an afterthought. Rather than designing a trial and then finding participants, your first task should be to engage the community—patients, peers, and patient advocacy groups—so as to better understand:
- The patient’s condition and daily life
- Barriers to participation
- Challenges with the trial design
- Desired outcomes
You may also want to implement monthly newsletters or surveys to keep your trial group involved and gauge their satisfaction or comfort levels.
By including the patient’s voice from the beginning and making them proactive participants in the trial design, you can create a trial that’s built upon a solid foundation and produced with meaningful outcomes in mind.
#5 Consider the common reasons for dropping out
Clinical trial participation is voluntary. As a result, patients can opt to leave a study as they see fit.
If you want your trial to finish on time and under budget, patient retention is key. A high percentage of dropouts can impact both the timeline and the quality of the trial. And if enough people drop out, it could force you to pause the process entirely.
This is a significant problem for the life science industry. According to the National Academies Press (NAP), patient dropout rates in phase 3 clinical trials “can often be very substantial,” sometimes more than 30%.
Although there may be unavoidable reasons causing a patient to drop out, many of those are preventable more often than not. Examples include:
- Inconvenient location
- Scheduling conflicts
- Financial constraints
- Forgetting visits
- Complex protocols
- Fear and anxiety
- Lack of appreciation
- Misunderstood expectations
For trial designers and clinical staff, it’s vital that you anticipate problems early on so that you can address them before a client decides to drop out. And when it comes to trial design itself, you must purposefully alleviate as many of the common pain points as possible.
Even something as simple as a small cash stipend for food and transportation could mitigate financial factors that might make trial participation more difficult. Doing so is completely ethical so long as the compensation is neither “coercive nor at the level that would present undue influence.”
#6 Listen to patient sentiment
How people think or feel about the clinical trial will impact their participation. However, patient sentiment is often difficult to measure. Sometimes words don’t align with underlying feelings. Or sentiments may oscillate daily, especially for something as complex as a mounting health issue.
Clinical trials, especially ones that operate remotely in some capacity, rely on countless text and voice communications between participating members. Whether it’s surveys, interviews, focus groups, or expert panels, attempting to parse all of that information becomes a significant hurdle.
Put simply, clinical trials are vulnerable to communications and insight gaps. And when that happens, it can compromise your overall efforts. Fortunately, there are tools and technologies, such as Within3’s insights management platform, that allow you to gather and analyze patient sentiment, empowering you to:
- Process massive troves of data
- Monitor shifts in sentiment
- Identify factors that lead to dropouts
- Flag at-risk patients
- Highlight critical issues
- Ensure patient compliance
Technology as a resource for optimized clinical trials
Recruitment for clinical trials can be a lengthy and complex process. Fortunately, you can acquire qualified candidates by leveraging technology, communicating the trial design clearly, and being transparent about expectations.
Then, once you have successfully launched your trial, you must pay careful attention to patient feedback or concerns throughout the process to retain your trial group.
Taking those steps and implementing the right technology, like a clinical trial feasibility assessment tool, puts you and your team in a position to succeed.
MD Group. The True Cost Of Patient Drop-outs In Clinical Trials. https://mdgroup.com/blog/the-true-cost-of-patient-drop-outs-in-clinical-trials/
NIH. The Need for Awareness in Clinical Research. https://www.nih.gov/health-information/nih-clinical-research-trials-you/need-awareness-clinical-research
The Hill. Nearly half of Americans don’t trust the CDC and FDA — that’s a problem. https://thehill.com/opinion/healthcare/553600-nearly-half-of-americans-dont-trust-cdc-and-fda-thats-a-problem/
NCBI. The Uphill Path To Successful Clinical Trials. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3684189/#b1-ptj3804225
FDA. Payment and Reimbursement to Research Subjects. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/payment-and-reimbursement-research-subjects