linical trials are evolving, but not fast enough. Despite major advances in science and technology, many studies continue to be slowed by recruitment barriers, participant burden, and structural inequities that keep large segments of the population out of research entirely. At the same time, healthcare delivery is rapidly shifting toward more flexible, home-based models, creating a pivotal moment for the clinical research enterprise to rethink how—and where—trials are conducted.

Expanding Access, Reducing Burden: Why This Matters

Clinical trials remain the cornerstone of evidence generation, yet systemic inefficiencies continue to delay therapeutic innovation. Recruitment timelines often stretch months beyond projections, with attrition rates climbing as participants face frequent site visits, complex procedures, and burdensome data collection requirements. These challenges are not simply operational—they directly undermine compliance with Good Clinical Practice (GCP) and delay regulatory submissions needed to bring new therapies to patients.

Traditional site-centric designs also perpetuate inequities. Elderly patients, individuals with disabilities, and those in rural communities are routinely excluded due to geographic and logistical barriers. The result is a trial ecosystem that is costly, slow, and insufficiently representative of real-world populations.

The Hospital at Home (HaH) model—originally conceived for acute care delivery innovation—has emerged as a transformative pathway for decentralized clinical trials (DCTs) to leverage standard healthcare systems and offer care to clinical trial participants as appropriate. Since the launch of the Centers for Medicare & Medicaid Services (CMS) Acute Hospital Care at Home program, more than 400 hospitals across 39 states have demonstrated that acute care can be safely delivered in patients’ homes. A 2024 CMS evaluation confirmed reduced mortality, shorter lengths of stay, and improved patient satisfaction compared to inpatient care. For clinical research, this large-scale demonstration provides proof that administratively complex trial designs can be safely decentralized, offering a regulatory precedent for sponsors to build upon.

Recent expansions in 2025 show continued momentum: several major health systems (e.g., Mount Sinai Health System, NewYork-Presbyterian, Nemours Children’s Health, Valley Health System, St. Luke’s Health System, and Intermountain Health) have launched new HaH programs to relieve hospital capacity pressures and improve patient experience. These developments highlight scalability and reinforce the potential of HaH models to reshape trial design at a national level.

Foundations of HaH in Research: What We Know

The integration of elements of the HaH model into clinical trials requires a sophisticated ecosystem of technologies, workforce models, and regulatory alignment.

The FDA’s final guidance on Conducting Clinical Trials with Decentralized Elements (2024) emphasizes that decentralized approaches must meet the same standards for safety, data integrity, and oversight as traditional site-based trials. Complementary international efforts, such as EMA’s recommendations on decentralized trials under the ACT EU initiative, reinforce harmonization and risk-based quality management.

Evidence from peer‑reviewed studies strengthens the case for trials that integrate HaH elements:

• An Annals of Internal Medicine study showed that elderly patients with pneumonia, heart failure, and COPD achieved outcomes equal to or better than inpatient care when managed at home. Continuous monitoring enabled rapid escalation, proving feasibility in populations often excluded from trials.
• A JMIR Cancer feasibility study demonstrated feasibility of remote physiological data collection in oncology patients, congruent with clinical outcomes and high patient acceptance. Lessons included iterative device validation cycles, real-time anomaly detection, and comprehensive onboarding to mitigate technology literacy barriers.
• A Journal of the American Geriatrics Society study highlighted telehealth-enabled nurse visits and continuous monitoring in heart failure patients. Standardized escalation criteria and telemonitoring alerts preserved protocol fidelity and safeguarded patient safety.

A number of recent studies provide additional support:

• A 2025 JAMA Network Open commentary emphasized the need to scale HaH beyond pilot programs, citing workforce shortages and reimbursement uncertainty as barriers.
• A 2024 BMC Health Services Research study articulated the “program theory” of HaH, showing how multidisciplinary teams and digital infrastructure interact to deliver safe, patient-centered care.
• A 2025 Age and Ageing systematic review synthesized patient, caregiver, and clinician perspectives, underscoring the importance of trust, communication, and clear escalation pathways in HaH models.

Implications for Stakeholders

HaH‑inspired DCTs, which integrate selected elements of HaH, redefine expectations across the ecosystem:

• Sponsors gain accelerated recruitment, enhanced data granularity through continuous monitoring, and streamlined site management. Decentralized trials integrating elements of HaH accelerate recruitment by removing geographic barriers, allowing broader participation from elderly, rural, and socioeconomically disadvantaged groups. For example, feasibility studies in JMIR Cancer and JAMA Network Open show that home-based monitoring increased enrollment by over 20% compared to site-centric designs. Continuous monitoring provides longitudinal data sets, enabling earlier detection of safety signals and more precise efficacy assessments, consistent with FDA expectations under Digital Health Technologies guidance. Streamlined site management reduces reliance on physical infrastructure, shifting resources toward digital oversight and centralized review. This lowers costs and improves scalability, especially in multicountry trials. The HIMSS 2024 study on HaH care models highlights that integrating elements of HaH and digital approaches can streamline operations and improve scalability, supporting faster activation of decentralized trials. Decentralized approaches also strengthen resilience, ensuring continuity of evidence generation during disruptions such as pandemics or natural disasters.
• Patients and caregivers experience reduced logistical burdens, improved convenience, and greater engagement, which directly improves retention. Elements of HaH in trials eliminate frequent travel, reducing costs, stress, and time away from work or caregiving. Receiving therapies and monitoring at home fosters trust and adherence, while caregivers benefit from reduced disruption and greater involvement. Engagement improves through digital tools that provide health feedback and progress tracking. In fact, a 2025 Age and Ageing systematic review found that patients reported higher satisfaction and willingness to continue participation, citing better communication and less disruption to daily life. Although this review focused on elements of HaH as a care model, its findings can be extrapolated to clinical trial contexts, where similar reductions in burden are expected to improve retention. Retention rates rise as participation aligns with patients’ realities, especially in long-duration studies such as dementia or cardiovascular trials. Implementation of HaH elements also reduces caregiver burnout by minimizing travel and scheduling burdens, allowing caregivers to focus on their supportive roles.
• Regulators see alignment with initiatives such as the FDA’s Advancing Real-World Evidence Program, which encourages integration of real-world data into regulatory decision-making. Regulators view the integration of HaH elements into trials as advancing policy goals to integrate real-world data (RWD) into clinical trial frameworks and post-market evidence generation to strengthen regulatory evaluations and patient-centered outcomes. The FDA’s Advancing Real-World Evidence Program encourages decentralized approaches that capture data outside traditional sites. Continuous monitoring produces RWD streams that complement controlled trial data, supporting submissions with both traditional endpoints and novel digital biomarkers. The EMA ACT EU initiative similarly emphasizes decentralized trials to improve diversity and data quality. Integrated elements of HaH models also advance requirements on statistically appropriate population sampling by enabling participation from underrepresented groups, aligning with components of the FDA’s 2024 Diversity Action Plans guidance that now has been put on hold because the guidance was issued only in draft form and never finalized, and in early 2025 the FDA suspended diversity-related initiatives following executive orders directing federal agencies to roll back equity and inclusion programs. Digital platforms provide audit trails, secure transmission, and compliance with 21 CFR Part 11, reinforcing confidence in submissions. Regulators further recognize HaH elements as a mechanism to sustain trial activity during public health emergencies without compromising safety or integrity.
• Investigative sites transition toward hybrid operational models, balancing digital oversight with decentralized participant support. Sites are evolving into hybrid models that combine digital oversight with decentralized care. They remain central for protocol design and compliance but shift toward coordination rather than direct patient management. Remote platforms allow investigators to monitor participants, review continuous data, and intervene when needed, reducing in-person visits while maintaining fidelity. Mobile teams—nurses, pharmacists, and technicians—deliver investigational products and manage emergencies in patients’ homes. This requires new competencies, including training in digital systems and risk-based monitoring. The BMC Health Services Research study emphasized multidisciplinary collaboration as key to success. Financially, sites benefit from reduced overhead while expanding catchment areas and remaining competitive. Hybrid models also strengthen resilience, enabling continuity during crises such as pandemics by shifting activities to remote oversight and home-based care.

Importantly, HaH programs advance inclusivity. The Massachusetts Department of Public Health’s Hospital at Home initiative reported significant increases in enrollment of minorities and socioeconomically disadvantaged groups in dementia care trials. This directly addresses regulatory imperatives to improve diversity in clinical research.

Recent meta-epidemiological evidence from the BMJ (2025) confirmed that treatment effects observed in decentralized trials are consistent with those in traditional designs, reinforcing credibility and regulatory acceptability.

Operational complexities remain: investigational product shipping, cold chain adherence, and emergency response protocols must be addressed through harmonized safety frameworks. Data integrity challenges require calibration, standardization, and integration into compliant electronic data capture systems. Privacy safeguards under HIPAA and GDPR must be embedded into trial design.

The Road Ahead:

HaH models have matured into a regulatory and scientific frontier for decentralized research. To sustain integration, stakeholders must act decisively to:

• Codify harmonized safety protocols across jurisdictions to ensure consistency in trial conduct.
• Institutionalize workforce training for mobile clinical teams and digital oversight roles.
• Advocate and generate recommendations that define and separate reimbursement for required clinical care and research procedures to stabilize financial models and reduce healthcare system risks.
• Invest in interoperable digital infrastructure to support secure, scalable data exchange.
• Strengthen partnerships among sponsors, regulators, technology firms, and patient advocates.

The HIMSS 2024 study on HaH Care Models emphasized that collaboration, regulatory clarity, and stakeholder synergy are enabling conditions for success. While the report focused on care delivery, these principles can be extrapolated to decentralized trials, where such collaborations are expected to reduce start-up times, improve data quality, and enhance the participant experience.

Conclusion: Advancing Research, Empowering Patients

HaH‑inspired decentralized trials, which adapt selected HaH practices, confront entrenched barriers in recruitment, retention, and diversity while aligning with evolving regulatory frameworks.

Call to action:

• Researchers should design protocols that embed HaH principles, leveraging validated digital tools and risk-based quality management.
• Regulators must continue to refine guidance to ensure flexibility without compromising safety or data integrity.
• Industry sponsors should invest in interoperable infrastructure and collaborative partnerships to scale adoption.
• Healthcare systems must prepare workforce capacity and operational models to support decentralized care delivery.

Within three to five years, these actions can yield trials that are more inclusive, efficient, and scientifically rigorous, accelerating the delivery of transformative therapies worldwide and reducing the number of failed medical products.