Home Trial Support: A Crucial Tool For Patient-Centered Clinical Trials

Recruiting participants in a clinical trial can be challenging even for the most experienced sponsors and sites. That’s to say nothing of retaining them — from travel to participation costs as well as communication issues to time commitments, the obstacles to participating in a study can serve to alienate and discourage patients already facing significant health hurdles.

As the industry and regulators continue to prioritize patient engagement and experience in clinical trials, the value of reducing participant burden has emerged as a key tool in improving recruitment and retention. This is particularly true for rare diseases and cancer: in a study surveying more than 1,600 oncology patients, researchers found that the median unidirectional distance for NIH-sponsored Phase I trials was more than 40 miles, with a higher burden observed for low-income participants¹. For rare diseases, this burden is often significantly higher, frequently forcing participants to relocate to access treatment.²

Improving access to trials for rural and low-income patients is important both in terms of improving medical equity and for bolstering diversity in clinical studies. Inclusivity in clinical trials remains a challenge even in today’s evolving trial landscape — a 2020 analysis of 32,000 U.S. study participants found that every minority group evaluated was underrepresented relative to their percentage of the general population.³ Similarly, participation in clinical trials for rural populations has been historically low,⁴ underscoring the need for solutions that can bring trials to patients, and not the other way around.

While not every study can supply on-site care in whole or in part, there exist significant opportunities to pursue hybrid study models, which can help alleviate challenges with access that can prevent some patients from participating in a trial.

The Barriers To Clinical Trial Participation

With traditional studies, the ability to meet patients where they are can mean the difference between retention and dropout, as issues with accessing sites or traveling long distances to medical centers — particularly if participant compensation payments are insufficient or delayed — can significantly impact a patient’s decision to join or stay in a study. Moreover, for sponsors and study teams alike, adequately managing the logistics of recruitment and retention can be one of the most challenging aspects of study conduct.

The challenges linked to participant payments, travel logistics, and technology access all serve to hinder enrollment and engagement in clinical trials. Moreover, as more decentralized clinical trials (DCTs) are leveraged to fill research gaps, adequately supporting these unique study models requires solutions that center on in-home healthcare.

How Home Support Services Benefit Patients And Clinical Trials

Creating a truly patient-centered clinical trial means exploring options that break down the barriers to participation that distance and time represent. Solutions that incorporate home trial support in the form of community-based care are widely recognized by the industry and regulators as valuable to the broader clinical research and healthcare landscape.

In 2024, the FDA launched a new initiative, Home as a Healthcare Hub, in collaboration with patient advocacy groups, healthcare providers, and medical device suppliers, to begin promoting more solutions that advance healthcare equity and highlighting the increasing importance of patient-centered approaches to clinical and medical care. Advocacy efforts like this underscore the increasing importance of patient engagement and satisfaction in clinical trial conduct, paving the way for approaches that center participants to improve outcomes.

Ultimately, home trial support services can improve patient access to clinical trials through a number of hands-on approaches, including:

• Facilitating Enrollment: Home Healthcare Professionals (HCPs) can assist patients with the enrollment process, including: scheduling appointments, collecting necessary documentation, and providing support during the informed consent process.
• Providing Support: Home HCPs can provide emotional and practical support to patients participating in clinical trials, helping to improve their overall experience and increase the likelihood of completion.
• Enabling Remote Trial Conduct: The right home health solution can allow HCPs to administer medical procedures that would ordinarily require patients to visit a trial site, such as investigational medical product (IMP) dosing, diagnostic tests, wellness checkups, and other key activities.
• Monitoring Patient Health: Home HCPs can monitor patients’ health and adherence to study protocols, ensuring they remain eligible for the trial and reducing the risk of dropout.

Moreover, the right home health solution, supported by regional networks and comprehensive care coordination, can improve the trial experience for both patients and trial teams. Home HCPs alleviate the pressure on trial teams at no additional cost to the site, creating another resource for administering medical care in a more accessible and flexible manner. Solutions with integrated technology platforms, site onboarding, training, and ongoing communication, collaboration, and support can further improve a study’s conduct, resulting in better retention and clinical outcomes.

The Future Of Patient-Centered Clinical Research

Ultimately, today’s clinical research landscape is more complex than ever before and finding ways to reduce this complexity will be key to supporting the trials of the future. An in-home component for a study, done right, can go a long way toward improving both research and health outcomes, and finding a partner that can handle the intricacies of bringing a clinical visit into someone’s living room is core to this evolution.

From legal and ethical adherence to pharmaceutical management, investigational medicinal product (IMP) storage, sample and supply management, and dosage transport and administration, the right home health service can make clinical home visits a reality for the right studies. Combine this with a track record of clinical success, data management, and clinical team collaboration, and a clinical trial or program can position itself for more inclusive, smoother studies.

Medical Research Network (MRN), an innovative clinical trial delivery company, has pioneered a community-based model that brings trials closer to patients, increasing trial recruitment and often achieving retention rates of more than 95%. Its global Site Network and in-home trial delivery work to engage and empower community research sites, increase patient access, and improve the recruitment and retention of a diverse patient population, providing the industry with solutions that make trials more efficient, inclusive, and accessible all over the world.

References:

1. Borno HT, et al. At What Cost to Clinical Trial Enrollment? A Retrospective Study of Patient Travel Burden in Cancer Clinical Trials. Oncologist. 2018 Oct;23(10):1242-1249. doi: 10.1634/theoncologist.2017-0628. Epub 2018 Apr 26. PMID: 29700209; PMCID: PMC6263122.
2. Gelinas L, et al. Relocation of study participants for rare and ultra-rare disease trials: Ethics and operations. Contemporary Clinical Trials, Volume 84, 2019, 105812, doi: 10.1016/j.cct.2019.105812.
3. Kelsey, M.D., B. et al. (2022). Inclusion and diversity in clinical trials: Actionable steps to drive lasting change. Clinical Trials, 19(10), 1067-1074. doi:10.1016/j.cct.2022.106740.
4. Ladd DL, et al. Promoting rural residents’ participation in clinical trials: clinical trials basics programming and training for rural public librarians. J Med Libr Assoc. 2023 Jul 10;111(3):722-727. doi: 10.5195/jmla.2023.1650. PMID: 37483365; PMCID: PMC10361552.