Clinical trials are essential for advancing medical research and developing new treatments. Gathering accurate and comprehensive data from these trials is crucial for ensuring the safety and efficacy of new therapies. However, the journey for patients who enroll in these trials often involves significant time commitments and various activities that can be burdensome.
When patients sign up for a clinical trial, they are not just agreeing to take a new medication or undergo a procedure; they are committing to a series of tasks and responsibilities that can impact their daily lives. For instance, patients may need to attend frequent clinic visits, undergo numerous tests and procedures, and adhere to strict medication schedules.
Since 2011, the burdens clinical trial patients face is up more than 50% for late-stage non-oncology studies – specifically in Phase II and III protocols (Tufts University, 2024). Looking even further, more than half of the patient dropouts are by choice, not because of side effects or dismissal by trial staff. High dropout rates in clinical trials significantly impact a study’s cost, length, data quality due to incomplete data sets, and statistical power.
Understanding and addressing patient burden is essential for improving the overall experience and outcomes of clinical trials. By recognizing the challenges patients face, researchers and healthcare providers can work towards creating more patient-friendly trial designs that minimize inconvenience and enhance participation.
Why do patients drop out of clinical trials?
There are several common barriers that patients face in clinical trials beyond medical reasons, such as transportation, burdensome protocols, mistrust and time commitment. These obstacles can impact caregivers as much as the patients themselves. At EmVenio, we’re aware of these challenges and actively work against them to create a more supportive experience, driving the overall success of studies we complete. Let’s dive deeper into the issues.
Transportation
Transportation and travel time are a major barrier for clinical trial patients. Not only do patients need reliable transportation to get them to the site, but many have to travel hours in order to get the potentially life-saving care they need, with 70% of potential patients living more than two hours from a study center. Additionally, the financial costs associated with these visits, such as fuel, parking, and potential lost wages, can further burden patients and their caregivers.
EmVenio removes this obstacle by strategically placing community-based research sites in accessible locations. By analyzing social determinants of health, our team finds areas that lack access to clinical research opportunities, have a vast prevalence of chronic conditions and health adversities, and have a higher number of diverse and underrepresented populations to allow for better representation. We also take into account the most commonly used transportation methods in each region, strategically locating sites near public transportation hubs or having plenty of parking to enhance accessibility. This data allows us to bring trials directly to the communities that need it the most, opening access to patients new to clinical trials and making it easier for them to take part.
Additionally, EmVenio collaborates with PCM Trials, our parent company, to offer mobile visits. Certified Mobile Research Nurses travel directly to patients, further reducing their burden. These visits allow patients to receive care and participate in trials from the comfort of their own homes, eliminating the need for travel and minimizing disruption to their daily lives.
Burdensome protocols
Did you know one of the top reasons people drop out of studies is because of all the extra work that comes with clinical trial participation? Think questionnaires, bloodwork and physical exams, which can be time consuming. While it might not be possible to eliminate these steps, EmVenio is here to lessen the burden.
Let’s take our brick-and-mortar research centers as an example. For patients who are enrolled in trials at these locations, routine bloodwork or MRIs are easier to collect because the trial is a part of a larger hospital system. Instead of having to drive to a separate location, patients can walk next door and get the next step done. Another way to complete these steps is by utilizing PCM Trials’ in-home mobile visit, bringing care to wherever patients are.
Eliminating burdens also requires innovation, which means implementation of new technologies. Recently, Phillip Stanford, EmVenio’s senior director of technology and innovation, participated in a webinar discussing this very topic.
Mistrust
Trust is a major component of a successful clinical trial. In order to build it, researchers need to engage with the community. This doesn’t include patients – it includes community organizations and leaders.
EmVenio prioritizes the well-being and involvement of patients, ensuring they are treated as valued individuals rather than mere test subjects. Our dedicated staff maintains ongoing communication with everyone involved in our studies, including those who may not complete the trial. This continuous engagement helps to build a strong rapport and trust.
To further strengthen this connection, EmVenio hires clinicians and PIs from within the community. By employing local healthcare professionals, we ensure that patients are interacting with familiar faces—neighbors who understand their unique needs and concerns. Additionally, these local clinicians are deeply invested in their community’s well-being, enhancing their commitment to personalized care and support throughout the clinical trial process.
EmVenio partners with local health centers and community organizations to participate in health fairs and events. At these gatherings, our clinicians explain the study’s goals and procedures, educating the public about the importance of clinical trials and their role in medical advancements. These sessions offer a platform for community members to ask questions and voice concerns, fostering transparency and understanding.
The team is committed to providing comprehensive explanations of the entire process, addressing all questions and concerns, and offering the necessary support to help individuals navigate and complete the study. By creating an inclusive and transparent atmosphere, EmVenio aims to enhance the overall experience for patients and contribute to the success of clinical trials.
Time commitment
Balancing trial participation with other life commitments, such as work, childcare, or caring for elderly family members, can be challenging. Around 45% of Phase II and III protocols require an average visit of two hours – almost three times higher than a decade ago. Adjusting protocols to reduce time commitments can alleviate that burden from patients. However, for protocols that cannot be adjusted, EmVenio provides solutions to ease the burden on patients and keep them engaged.
Many of the strategies EmVenio uses to address transportation barriers can be applied here, including leveraging our existing accessible, community-based site network to minimize travel distances, offering mobile visits where Certified Mobile Research Nurses travel directly to patients’ homes, and providing flexible scheduling options to accommodate patients’ other commitments.
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EmVenio and PCM Trial’s forward-thinking approach to clinical trials is changing the research landscape. Our commitment to inclusivity and patient-centric care ensures that every patient feels valued and supported throughout the trial process. In our team’s more than 800 studies conducted, we have achieved an average retention rate of 92%, 46% diverse patient recruitment, and 98.5% of study enrollment targets. Are you ready to get started?