Benefits of point-of-care clinical trials for sponsors

The benefits of point-of-care clinical trials for sponsors are becoming increasingly clear, especially as the industry shifts toward more patient-centric and flexible research models. By embedding trials directly into care settings, sponsors can accelerate recruitment, improve data quality, and reduce operational barriers. But is this approach right for every study? In this article, we explore when point-of-care trials work best, the key considerations for implementation, and how Siron Clinical can support your success.

What’s special about a point-of-care clinical trial?

The benefits of point-of-care clinical trials for sponsors go beyond convenience, they represent a strategic shift in how research is operationalized. As highlighted in a recent white paper by the Duke-Margolis Center for Health Policy, point-of-care clinical research, also known as Clinical Research as a Care Option, isn’t a specific trial design. Instead, it’s an operational approach that integrates seamlessly into real-world clinical workflows and can be applied across various trial types.

Traditionally, clinical trials rely on separate investigational sites, where patients attend dedicated visits solely for data collection. In contrast, point-of-care trials are embedded within routine patient care, allowing participants to be monitored during their standard healthcare appointments, whether at home or in clinical settings. Data is often captured in real time through the patient’s electronic health record (EHR), improving speed, consistency, and relevance.

This approach not only accelerates timelines but helps trials stay tightly aligned with real-world outcomes, enhancing both efficiency and patient-centricity.

Below, we outline the key benefits and challenges of running point-of-care clinical trials, based on our experience supporting sponsors across diverse study environments.

Benefits of point-of-care clinical trials

• Recruitment is more targeted. Recruitment is one of the biggest challenges in the clinical trial process. By tapping into existing patient records, point-of-care trials can overcome this challenge. Participants are identified according to factors such as specific genetic markers or rate of disease progression in addition to demographic parameters, using the EHR system. In some cases, investigators contact individual patients to discuss joining the trial as part of their ongoing care. This more targeted recruitment saves time and ensures the best pool of participants for the trial.
• You put patients at the heart of the research. Patient-centered clinical trials bring greater benefits to those they are intended to serve: the people who need the treatment on trial. When research is conducted as part of ongoing healthcare processes, patients may have better access to a trial that could otherwise be out of their reach.
• You can save time and money. The point-of-care approach requires the research to be aligned with existing clinical processes. This means the additional burden placed on clinicians is minimized, as they can carry out research visits during regular patient visits. Time and money are also saved in the data collection process: according to Jodyn Platt, PhD, MPH, an assistant professor of learning health sciences at the University of Michigan, 90% of the data collected in clinical trials is irrelevant, either because it isn’t used or because it’s “not germane to the primary endpoint.” When research is part of clinical care, data collection can focus on the endpoint – such as duration of hospitalization, making it more efficient.

Point-of-care clinical trials also bring challenges

Technology integration is improving, but not seamless.

While the EHR remains central to point-of-care trials, it still isn’t a one-stop solution. Significant progress has been made in integrating eSource, AI-driven patient matching, and eConsent tools. Sponsors typically still need add-on systems or partner solutions to ensure data flow and interoperability.

Not all studies are a good fit.
Point-of-care implementation is most effective for trials involving approved treatments tested in new populations or indications, particularly when safety profiles are well known and outcomes are objective and easily measurable (e.g., readmission rates, mortality). Conversely, trials requiring intensive monitoring, complex lab testing, or tight randomization protocols may not be feasible in a care-embedded model, especially if the infrastructure isn’t equipped to manage investigational products.

Administrative and regulatory complexities remain.
Despite growing regulatory acceptance of decentralized and embedded models, administrative burdens can still delay POC trial start-up. Sponsors must navigate informed consent, data privacy (especially GDPR in Europe), site qualification, and IRB/ethics approvals, often across heterogeneous healthcare systems. Coordinating these processes between care providers and CROs requires early planning and expert oversight.

What does the future look like? Benefits of point-of-care clinical trials for sponsors

As clinical research becomes more deeply integrated into routine care, the healthcare system evolves into a learning ecosystem, one that continuously adapts, improves, and accelerates access to innovation. Point-of-care clinical trials play a key role in this transformation. By embedding research into everyday practice, these trials make participation more accessible, diverse, and representative, turning clinical trials into a standard part of care delivery, not a separate process.

For sponsors, this signals a shift in expectations and opportunity: faster recruitment, real-world data generation, and greater alignment with patient needs. As technology and regulatory frameworks catch up, point-of-care trials are poised to become a strategic pillar in the future of clinical development.

FAQs: Benefits of point-of-care clinical trials for sponsors

When are point-of-care clinical trials most effective?

Point-of-care trials are most effective when studying approved treatments in new populations or indications, especially when the drug has a known safety profile. They’re ideal for studies with objective endpoints that can be tracked through existing clinical workflows, such as hospital readmissions, medication adherence, or mortality rates.

What are the key challenges in implementing point-of-care clinical trials?

The main challenges include technology limitations, as no single system currently supports all aspects of embedded trials; regulatory complexity, particularly around data privacy and informed consent; and fit-for-purpose trial design, since not all interventions or endpoints are suitable for care-integrated models.

If you need support setting up your point-of-care clinical trial, contact Siron Clinical to discuss your options.