Patient Retention in Clinical Trials: Overcoming Challenges To Drive Success

Feb 4th, 2025

Patient retention is vital to the success of clinical trials, yet it doesn’t always receive the same level of attention as patient enrollment. For sponsors and contract research organizations (CROs) to meet their trial goals and stay on schedule, they need to hold onto the participants they’ve worked so hard to get in the door. Clinical trial recruitment fills your pipeline, retention keeps it flowing—and without it, research studies are prone to falter.

Patient Retention in Clinical Trials: The Other Side of Recruitment

While patient recruitment often dominates the conversation in clinical trials, retention is just as important to a study’s success—if not more so. The reality is that enrolling clinical trial participants is only the beginning. There’s a need for clinical research professionals to keep these individuals engaged throughout a study to provide consistent data that supports trial endpoints and regulatory requirements. When retention efforts falter, the impact ripples across timelines, budgets, and data quality, threatening the entire study.

1. The Financial Toll of Dropouts

High dropout rates aren’t just inconvenient—they’re costly. Each time a participant leaves a trial prematurely, sponsors must scramble to recruit replacements, which can cost upwards of $19,000 per participant once onboarding, administrative overhead, and timeline adjustments are all factored in.

Beyond the immediate costs of replacement, delays caused by dropouts can extend the trial timeline significantly, leading to further financial strain. For studies nearing the final phases, these delays can push back regulatory submissions and product launches, potentially costing sponsors hundreds of thousands—or even millions—of dollars in lost revenue per day.

2. Delayed Timelines and Their Impact

When participants exit a study, the timeline inevitably suffers. Recruitment to replace dropouts isn’t instantaneous, and onboarding new participants adds additional time. These delays can bottleneck trial progression, affecting everything from data analysis to regulatory submission.

For sponsors and CROs, extended timelines also risk loss of stakeholder confidence and market opportunities. Delayed approvals mean delayed access to life-saving treatments for patients, compounding the consequences of poor retention.

3. Compromised Data Quality

Perhaps the most critical impact of poor retention is its effect on data quality. Losing participants mid-study can lead to incomplete datasets, jeopardizing the statistical power needed to draw valid conclusions. Missing data points create gaps in analysis and raise questions about the reliability of the study results. For regulatory bodies like the FDA, such inconsistencies can be cause for concern, potentially delaying or derailing the approval process altogether.

Where Patient Retention Gets Challenging

Certain clinical trial types or designs make it especially difficult to keep patients engaged and invested. They include:

Long-term trials: When clinical trials span months or even years, participants may lose motivation due to “trial fatigue,” life changes, or reduced perceived value of their involvement.
Complex study protocols: Trials requiring frequent site visits, intricate treatment regimens, or invasive procedures can feel burdensome to participants, leading to frustration and disengagement.
Decentralized and hybrid trials: Participants who interact primarily through technology may feel disconnected from the study team, reducing their sense of accountability. Tech-related issues, such as app malfunctions or difficulties in remote monitoring, can further contribute to dissatisfaction.
Rare disease trials: These trials often require intense engagement due to complex procedures or travel to specialized centers.
Vulnerable populations: Trials targeting elderly patients, low-income populations, or individuals with chronic conditions may face retention challenges due to transportation barriers, health complications, or financial stress.

Signs of Patient Engagement: The Obvious and the Subtle

Patient retention begins with engagement, but identifying when clinical trial subjects are truly engaged can be nuanced. Here are some key indicators to monitor:

The More Apparent Signs of Engagement

Timely Attendance: Participants consistently show up for visits or virtual check-ins.
Protocol Adherence: Participants follow study protocols, including medication schedules or lifestyle modifications, without significant reminders.
Proactive Communication: Engaged participants ask questions, report side effects promptly, and seek clarifications about their role or the clinical trial process.

The More Understated Signs of Engagement

Expressing Curiosity: Participants who show interest in trial progress or the study’s potential impact often feel invested in the outcome.
Positive Interactions with Staff: Warm, conversational exchanges with study coordinators indicate a level of comfort and connection.
Personal Ownership: Subtle signs, like a participant keeping track of their appointments independently or taking detailed notes during visits, signal active involvement.
Adherence to Tech Tools: In DCTs, frequent use of apps or digital diaries without prompting suggests participants are engaged and confident in their role.
Unsolicited Feedback: Participants who voluntarily share observations, challenges, or suggestions demonstrate a sense of responsibility and partnership in the clinical trial.

Key Strategies To Enhance Patient Retention

1. Prioritize Transparent Communication

Effective communication is the foundation of patient retention. Regular updates about trial progress, study outcomes, or procedural changes keep participants informed and invested. Establish a two-way feedback loop to address concerns promptly to make sure participants feel heard and valued. Offering multiple methods of communication makes it easier for participants to reach the study team.

2. Incorporate Participant-Centric Design

Adapt study protocols where feasible to best align with participants’ lives. Offer virtual visit and at-home delivery options to reduce the burden of coming to sites as frequently. When patients do have to come on site, give them the option to schedule evening or weekend appointments as well as take advantage of site transportation services.

3. Provide Incentives and Recognition

Beyond monetary compensation, small gestures can foster goodwill and motivation among patients. Create a welcoming environment that includes thoughtful touches like refreshments, Wi-Fi, or relaxation areas during long appointments. These details can make participants feel comfortable and valued.

4. Engage Caregivers and Families

Support systems play a significant role in a participant’s level of engagement. Share easy-to-understand materials about the trial’s goals and procedures so caregivers and families can better support participants. With the participant’s consent, include them in updates and communications to keep everyone aligned on the trial’s requirements.

5. Build Strong Patient Relationships

A participant’s connection with the study staff plays a significant role in their likelihood to remain in the trial. Assign each participant a single contact person who can address their questions, schedule changes, or concerns promptly. Train staff to engage with participants empathetically and periodically check in with participants to see how they’re feeling about their participation.

Patient Retention As a Site Selection Factor

Retention-focused strategies start at the site level. When selecting a clinical trial site, sponsors and CROs should evaluate both patient recruitment and retention strategies. That way, they'll have more confidence in their ability not only to find eligible patients but to retain patients for a clinical study.

Here are some considerations:

DCT & Hybrid Experience: Does the site have experience managing decentralized or hybrid trials? Are they equipped with technology and staff to meet remote trial needs?
Flexibility: Does the site offer adaptive scheduling or alternative visit options?
Participant Communication: Is the site proactive in keeping participants informed through reminders, updates, and follow-ups?
On-Site Experience: Are amenities like Wi-Fi, refreshments, and private waiting areas offered to improve the patient experience?
Staff Expertise: Does the site employ experienced coordinators who can effectively manage retention strategies and participant relationships?
Track Record: How has the site performed in retaining participants for similar trials?

Why Sponsors & CROs Trust Remington-Davis

At Remington-Davis, patient retention is embedded in everything we do. Here’s how we consistently deliver:

Retention-First Approach: Our 98% retention rate is a testimony to our patient-centric design, comprehensive communication, and adaptable services.
Decentralized Trial Expertise: From hybrid trials to fully remote designs, we have the infrastructure to meet participants’ needs wherever they are.
Unmatched Participant Support: We make participants feel valued every step of the way, from home-like amenities on site to staff that continuously listens to their feedback.

Partnering with Remington-Davis means choosing a clinical research site that prioritizes patient retention and data integrity. Contact us today to learn how we can help support your clinical trials’ success.

Frequently Asked Questions About Patient Retention in Clinical Trials

Why is patient retention just as important as recruitment in clinical trials?

While recruitment brings participants into the study, retention ensures they stay engaged through its entirety, allowing researchers to collect comprehensive data that meets regulatory requirements. By integrating robust recruitment and retention strategies, clinical trial sites can build a seamless pipeline where participants feel valued and supported to drive better outcomes and smoother trial completion.

What factors influence clinical trial participation and retention?

Clinical trial participation and retention are influenced by a variety of factors, including the convenience of the study design, the level of communication with participants, and the availability of logistical support. Trials with simple protocols, flexible scheduling, and virtual or hybrid options tend to see higher participation rates because they minimize disruptions to participants’ daily lives. Ultimately, participants are more likely to remain engaged when they feel their time and effort are valued, and their contributions are making a difference.

How do logistical barriers affect retention in the clinical trial industry?

Logistical barriers are a leading cause of participant dropout in clinical trials. Factors like long travel distances, frequent site visits, or complex treatment regimens can frustrate participants, particularly if they lack the resources to meet these demands. Decentralized and hybrid trial models have emerged as solutions to these challenges, offering options like at-home visits to reduce logistical strain.

How does participant feedback influence clinical trial conduct?

Feedback from participants plays a vital role in improving clinical trial conduct. By actively listening to participant concerns and making adjustments in response, clinical research sites can create a more supportive and engaging experience. For example, feedback might reveal that certain procedures are too time-consuming or unclear, allowing sites to modify protocols for better compliance.

How can sites balance recruitment and retention strategies effectively?

Clinical research sites that approach recruitment and retention as complementary priorities—rather than separate tasks—build trust with participants, minimize dropouts, and ultimately achieve higher-quality results. Recruitment efforts should focus on attracting diverse, eligible participants through targeted outreach, community partnerships, and patient education. Retention requires ongoing support that starts as soon as eligible participants enroll. This involves creating a positive experience through clear communication, logistical assistance, and incentives to maintain their engagement.