Retention Through Intention – Designing Truly Patient-Centric Trials In 2026

Identifying and recruiting patients before a clinical trial is critical to the data-gathering process, yet enrollment is almost always challenging. But sponsors should not consider the job done once a study kicks off. Dropout rates of 25% to 30% are common in clinical trials, and rates as high as 70% have been reported.1 For sponsors, the consequences of attrition include delayed timelines, increased costs, compromised data integrity, and even study failure.

When patients leave a study, sites typically have fewer resources available to dedicate to reenrollment compared to the initial enrollment phase. Globally, more than half of all clinical trials are terminated due to low recruitment.2 Of the trials that continued, more than 80% failed to enroll participants on time, resulting in study extensions or the addition of new study sites.3 The difficulty of reenrollment is exacerbated when site staff becomes overworked trying to simultaneously care for existing patients, implement new patients smoothly into the trial, and identify/correct issues that may have contributed to patients discontinuing participation.

A strategically implemented solution combining decentralized clinical trial (DCT) elements — such as in-home trial visits, satellite (or “pop-up”) clinics, hybrid telehealth, and community-based and / or trial-naive sites — can enhance patient enrollment and retention significantly. This is often achieved through Site and Patient Support (S&PS) without changes to the protocol. Maximizing this strategy requires identifying potential dropout risks during the protocol design phase, well before recruitment begins.

By identifying why patients may leave a study, sponsors can focus on targeted strategies to minimize the burdens placed on participants, their caregivers/families, and site personnel.

These resources can also play a key role in facilitating enrollment and encouraging retention for patients joining mid-study, as well as supporting the home healthcare providers (HCPs) who enable hybrid protocols.

Understand The Specific Impacts Of Targeted DCT Tools

Although sponsors may recognize the presence of a patient engagement issue — due to difficulty during initial enrollment and/or higher-than-expected attrition — pinpointing root causes can be challenging. A stringent, burdensome protocol could make participation unbearable, or site personnel may be spread too thin to prioritize the patient experience. Even when sponsors identify these problems, they may lack the expertise to integrate DCT elements mid-trial. Uncertainty regarding how DCT tools work, how to identify the most effective tools for a given trial, and how to successfully integrate them also can lead to significant risk aversion.

Hybrid models, which use DCT elements to enhance a traditional trial, are widely perceived to effectively improve patient experience and drive equity without sacrificing face-to-face access to HCPs.4 This perception appears universal regardless of the therapeutic area, including trials exploring oncology5 and cardiovascular6 indications.

Despite these benefits, site resistance can occur if sites believe DCT tools will inhibit their oversight capability, be cost-prohibitive, or impose additional burdens on personnel. Therefore, relationship building, site education, and open communication by any DCT provider are indispensable. This support helps the site maintain oversight and evaluate impact while capturing high-quality patient insights without the burden of manual data collection.

Sites can also be reassured by seeing evidence of the financial benefits associated with DCT solutions supporting faster enrollment and greater patient retention. While some studies have examined the per-patient cost of attrition and reenrollment to a trial 7, those costs can vary based on a multitude of factors. Rather than focusing on ill-defined negative repercussions, a DCT provider can show the sponsor and sites how that solution alleviates personnel burdens rather than increasing them. Enhanced expert support, clear education, and time/cost transparency all significantly influence clinical trial participation.8

It is also critical to recognize that “hybridization” does not require a 50/50 split and that DCT tools do not need to directly support patients or facilitate protocol execution to have a positive impact. Thoughtful application of telehealth and Home Trial Support (HTS) contribute to a bespoke care model that keeps patients engaged, reassuring participants and their families that they will receive adequate support throughout the study. These resources can also shorten recruitment9 and support high patient retention,10 even over multiple years, by maximizing flexibility to accommodate patient and caregiver needs.

Choose A Proven DCT Solutions Provider

Awareness is the most powerful tool in preventing attrition. Patient engagement – and the generation of high-quality real-world data – depends on three interconnected factors:

  • supporting the patient,
  • addressing the needs of family and caregivers, and
  • helping sites manage patient concerns and reenrollment.

Recognizing how these elements intersect is vital, as patient dissatisfaction is not always the cause of attrition. Participation burdens on family members or other caregivers, from travel and out-of-pocket costs to perceived lack of support or information, can make continued participation challenging. Similarly, site personnel may experience burnout or lack the resources to help patients feel informed and valued during the trial.

The best way to keep these issues from leading to attrition is to prevent them from occurring, and the first step in that process is partnering with a DCT solutions provider that has demonstrable experience and expertise.

This partner can proactively identify solutions to potential retention problems, as well as act quickly and decisively to resolve attrition root causes mid-trial. Beyond a proven track record across diverse therapeutic areas and geographies, a DCT provider should be able to engineer solutions tailored to the specific needs of each study, site, and patient population. This balance is crucial; alleviating patient burdens at the expense of site operations is not an effective resolution. A truly effective resolution must streamline the experience for all stakeholders involved.

By collaborating with sponsors before a trial begins, a DCT solutions provider can identify potential attrition risks before the trial starts. Analyzing study design through the patient perspective, informed by resources like patient-reported outcomes (PROs) and focus groups, is invaluable for pinpointing trial participation pain points. It also provides insight into how DCT elements might impact the patient or site personnel.

In many scenarios, the study protocol can remain unchanged, and additional patient and site support during participation and follow-up are sufficient to keep both groups engaged.

This can take the form of additional time spent providing the patient with emotional or physical support, which may include:

  • Physical and emotional care: Dedicated time for personalized patient interaction.
  • Informational support: Guidance on disease progression and condition management.
  • Lifestyle integration: Practical advice for patients and caregivers on managing the unexpected impacts of trial participation on their daily lives.

Reviewing case studies where DCT elements were implemented early can help sponsors improve retention and reduced dropout rates, as well as strengthen collaboration with sites through real-time visit reporting and aligned oversight.

Direct & Indirect DCT Impacts

Even the slightest tweak to make a clinical trial more site- or patient-friendly can have a positive impact on patient retention.

Consider GLP-1 clinical trials, which are prone to attrition due to challenging side effects, lifestyle disruptions, and social stigma surrounding obesity. MRN addressed this in a Phase 2 GLP-1 program by deploying specialized “Patient Navigators” to provide continuous telemedicine support to trial participants. Through personalized nutritional guidance, symptom management, and mental health reassurance with qualified HCPs, participants received the consistency and care needed to remain engaged throughout the study.11

Another study published in 2025 reinforced this approach’s effectiveness. It concluded that a patient navigation program designed to drive enrollment and retention among patients representing the diversity of the broader population was “feasible to implement, highly acceptable to patients, and reached a priority population of patients generally underrepresented in cancer clinical trials”.12

In another clinical trial, MRN applied DCT elements to support a pediatric Phase 2 clinical trial with high patient and caregiver burdens. The study evaluated an investigational oral therapy designed to boost utrophin production in boys with DMD. Trial visits included an intensive schedule of clinical assessments and pharmacokinetic (PK) sampling at five sites across two days, requiring vital signs monitoring, blood draws, and pre-/post-dose PK sampling, among other steps.13 By applying a flexible clinical trial delivery model in a patient-centered location, burdens on the patient and family staying at a Ronald McDonald House were minimized and all protocol-compliant procedures were delivered with zero deviations.

As a final example, consider Alzheimer’s disease (AD) clinical trials, which are notoriously difficult to enroll.14 Tools that enable earlier identification of cognitive impairment can encourage people to enroll in trials sooner, while digital methods for identifying patients in the early stages of impairment may substantially reduce trial duration and costs and improve outcomes.14

Patients with AD are also well suited for HTS, as their home is a safer, more familiar environment. Intrusive sounds, smells, and other stimuli in clinical settings can influence how treatment effects are observed and recorded. Thus, executing trial elements in the patient’s home is more likely to provide an accurate real-world picture of treatment response while reducing travel-related stress for patient and their caregivers.15 MRN has applied a similar approach to other studies complicated by cognitive impairment, such as  Parkinson’s Disease, providing additional site support that allows research teams to focus on patient care, rather than logistical challenges.16

Effective Trials Need Engaged Patients

DCT tools/elements can complement a trial protocol by providing additional support for patients and sites. A bespoke approach that considers patient, caregiver, and site burdens specific to the therapeutic area is most effective. As noted above, DCT elements can and should be used in conjunction with traditional trial settings and infrastructure to create a hybrid model – blending familiarity with increased convenience – that is preferred by most patients. Reduced travel and fewer barriers to participation are proven to boost both protocol adherence and patient retention, and evidence suggests DCT tools also encourage broader representation across patient demographics.

Engaging an experienced DCT solutions provider early, as the protocol is being created, is not only cost-effective but also gives sponsors a clearer understanding of available options, enabling greater flexibility in trial design. In turn, this approach ensures patients and sites are well supported throughout the study, easing enrollment and mitigating attrition. Built on extensive expertise and supported by a global site network, MRN’s DCT and Hybrid solutions have achieved a 95% retention rate across its partners’ clinical trials.

References:

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