Looking at clinical trials’ patient retention and enrollment statistics can be a little unsettling. Just over half of the research studies and drug development programs listed in the Clinical Trials Database ended prematurely because of enrollment issues; roughly 80% of clinical trials experience delays due to lagging patient enrollment; about one-quarter of all clinical trial participants eventually withdraw after giving consent to enroll; and the number of clinical trials experiencing delays when combining their enrollment issues with dropouts rises to 90%.

Regardless of how solid the science behind a treatment’s development is or how capable the team is of planning and executing the trial, success and better patient outcomes require patient trial participation. 

For that reason, they  require solid and consistent recruitment and retention because even when deftly navigating these issues, delays lead to considerable costs—sometimes approaching $500k per day—and lengthened timelines that keep broader patient populations from accessing the revolutionary treatments they need.

But contract research organizations (CROs), biopharma companies, and clinical trial staff always prove themselves resilient and dedicated. If there’s any industry capable of identifying a challenge and developing novel, ground-breaking solutions, it’s this one. While it’s true that success hinges on patient recruitment, engagement, and retention strategies, effectively executing these strategies is no small feat.

Why Patient Retention Matters in Clinical Trials

Simply put, if a trial can’t retain enough patients, it’s not really a trial anymore. Clinical studies without enough participants (i.e., underpowered trials) can’t determine a quality, significant conclusion from the data or apply it ubiquitously enough across different demographics and relevant patient populations.

However, a study is not required to maintain a minimum enrollment number, aside from at least one patient. Per the US Code of Federal Regulations (42 CFR Part 11), CROs, biopharma companies, and other clinical researchers must only submit estimated enrollment numbers and then update that figure upon reaching the trial’s completion date. Moreover, any trial can remain “ongoing” so long as “one or more human subjects are enrolled” and “the date is before the primary completion date.”

Meeting some regulatory mandate about maintaining minimum participation numbers isn’t the problem. As mentioned above, patient recruitment and retention matter in clinical trials because they directly affect the timeline delays, financial consequences, and—most importantly—the lack of broader treatment access.

Patient populations never gain access to revolutionary treatments stuck in lab limbo. The actual cost of an underpowered trial is the improved patient outcomes and happier lives that could’ve been achieved.

Common Challenges to Patient Retention

Before contending with patient retention challenges, a clinical study needs to meet the enrollment numbers specified in its protocol. So, poor enrollment—most commonly due to limited awareness among patients and their healthcare providers (HCPs)—represents the biggest challenge to retention.

For example, traditional trial recruitment methods involved physicians, nurses, and other healthcare providers becoming aware of trials and then referring patients they considered eligible. 

But that’s too many opportunities for this method to break down. 

The HCP might not know about pending or active trials, remain unfamiliar with the investigating team, or be reluctant to refer patients (as is all too familiar), resulting in fewer than half a percent referral rates among physicians and nurses’ total annual patient volume.

Digital, direct-to-patient (DtP) clinical trial recruitment strategies can significantly boost awareness in these cases, but addressing poor retention requires more than just effective recruitment. One study examined in a systematic review found that the most commonly reported challenges in recruitment and retention among patients include:

• 55%: The investigative team’s lack of a dedicated approach
• 47%: Fear of study procedures and needing to relocate
• 44%: Fear of side effects
• 27%: The primary care physician and family members’ lack of support
• 9%: Negative media attention and perceived treatment inefficacy

Expected and common-sense reasons dominate these figures. Unfortunately, patients experiencing logistical challenges (e.g., travel time and cost, relocation, missing work, parental or guardian responsibilities) may understandably feel the need to drop out. 

Concern regarding study procedures and side effects illustrates the insufficient information and educational materials, whether accessibility or understandability is the issue. Communication breakdowns between patients and investigative teams can reveal issues with the study protocol or misunderstandings of the study criteria, which may lead to missed appointments or medication schedules and ultimately impact patient retention.

Tips and Strategies for Improving Patient Retention

As every good clinical researcher knows, developing solutions requires understanding the challenge. The above figures provide the perfect insight for developing impactful patient retention strategies, enabling any CRO, biopharma company, or investigative team to defy broader industry trends.

Streamlined Communication

To combat the above dropout causes, streamlined and engaging communication may be the most important strategy. When investigative teams keep patients comfortably informed and provide access to supportive and educational resources, concerns about the team’s execution, research procedures, side effects, efficacy, and so on won’t plague patients.

Accomplishing this involves far more than sending along pamphlets. Streamlining clinical trial communication requires capturing informed consent and implementing a platform to centralize the information and communication channels (e.g., call, text, and email) that patient support staff must reference and utilize when providing assistance. 

It requires ensuring consistent, empathetic, clear, and patient-friendly messaging across all marketing and informational materials while meeting compliance regulations, like those of the Institutional Review Board (IRB).

Personalized Support for Participants

Researchers who streamline their communications still need to be proactive in their communication strategy and provide personalized support. They should also consider how to better accommodate patients (within the parameters of the study)  as they pursue treatment. 

Adding flexibility or assistance—coordinating their transportation or child care, sending appointment and medication schedule reminders, setting up virtual appointments, and offering group-dedicated resources for randomized controlled trials—goes a long way toward concretely demonstrating care and support.

Streamlining regular communication and personalizing support to break down logistical and other barriers achieves two significant benefits that improve low patient retention rates:

• It embeds treatment adherence as part of patients’ personal routines.
• Patients know they have the support systems sometimes needed to persevere through treatment during stressful periods admirably and keep pursuing better outcomes.

Community Support and Recognition

Incentives motivate people to pursue goals, and recognition helps them feel seen and appreciated, especially when they are struggling—what could be more critical to the patient journey? Building upon streamlined communication and personalized support, these two tools greatly boost patients’ clinical treatment adherence.

For example:

• Create or engage a patient advocacy group to develop an empathetic and encouraging community where patients can celebrate their various milestones with each other.
• Host events that bring broader visibility to patients’ experiences and spread awareness, taking time to recognize everyone (who consents and is comfortable with the attention).
• Send birthday and holiday wishes or random and spontaneous notes of encouragement and support—you never know when someone will need it.

These support and retention strategies don’t just keep patients engaged; they foster a deeper relationship with them, one which they’re eager and motivated to cultivate, too.

Leveraging Technology

The patient retention strategies above can drive impressive results, but they all require the right patient recruitment technology implementation to facilitate. With the growing extent of data, the complexity of compliance regulations, the inefficiency of manual efforts, coordination across multiple channels, and everything else patient support teams must juggle, clinical trial management systems and other technology tools for recruitment and care coordination become necessary.

Technology implementations to consider include:

• Launching a patient portal or engagement app to simplify data capture, scheduling, reminders, and progress tracking.
• Providing patients with wearables that help monitor their health and treatment and sending them periodic data visualizations that help them experience and recognize their own progress more tangibly.
• Setting up telemedicine for any appointment that doesn’t require an in-person visit is particularly important for decentralized clinical trials (DCT) or those treating patients in remote areas.

Building Trust and Transparency

Clinical trial organizers can cultivate some trust and deepen relationships with patients through the regular, personalized communications explored above. However, trust is built on more than encouragement and receiving messages—as the saying goes, “It’s a two-way street.”

Trust comes from ensuring:

• Patients understand everything they need to adhere to treatment
• Patients know how to access whatever they’re seeking (e.g., information, supplies, guides to administering medication, support resources)
• Patients know who to ask when it comes to anything else

Trust also develops when clinical research teams consistently and promptly reply to patients’ inquiries. Patients know they’ll receive support because they always do. 

If patients express concerns about the treatment, clinical trial process, study motives and goals, side effects, or anything else bothering them, they need to receive clear, simple, prompt answers delivered with empathy.

Just remember that every patient will be different. While clinical trial conduct should include empathy, some patients might seek frequent support, while others might feel deprived of agency when they are ‘hand-held’ too much. 

Of course, it’s easier to track patient preferences when adopting a personalized approach and using technology tools to manage them. Adhering to individuals’ personal preferences builds mutual respect and trust.

Monitor Patient Feedback and Adjust

You need to ask patients directly to best understand the challenges they face along their treatment journey, which contributes to lower retention numbers. Start by setting up multiple feedback channels and mechanisms, such as SMS or phone surveys, a designated tab in their patient portal, and even physical forms when patients visit for appointments.

Through these feedback channels, you can query patients rather than trying to guess or extrapolate their experiences, struggles, motivations, goals, and more.

After gathering the feedback from participants enrolled, periodically review it to determine what program adjustment should be made. Remember to roll out most adjustments incrementally and within a test group before going live to confirm they’re ready for launch—and determine metrics and key performance indicators ahead of time to track results and over-time improvement.

Streamline, Simplify, and Scale Your Patient Recruitment and Retention Strategies

Revolutionary medicines and treatments don’t belong in lab limbo. Still, they’ll never reach broader patient populations without successful clinical trials involving enough eligible and engaged participants from sufficiently diverse and randomized demographics. 

The strategies here will help clinical researchers get started and better retain patients—but when it comes time to streamline, simplify, and scale them, it’s time to connect with AutoCruitment.

AutoCruitment’s digital clinical trial recruitment approach creates a massive pool of eligible and qualified potential study participants. It leverages targeted marketing across digital and social channels, patient engagement portals for speedy enrollment and onboarding, artificial intelligence and machine learning to enable screening of candidates’ electronic medical records and additional services like second-line phone screening.

Marketing, recruitment, and engagement should never be the most challenging aspects of clinical research—it’s time for science to resume that role. 

Reach out to AutoCruitment today to learn more about the leading solution for clinical trials’ patient retention and engagement challenges.