Telehealth In Clinical Trials: What You Need To Know

By John Oncea, Editor

Telehealth is a tool, not a trial design. Learn how televisits, ePRO, and remote monitoring fit into traditional, hybrid, and decentralized clinical trials.

Clinical trials take time. The University of Cincinnati College of Medicine reports that a Phase I trial typically takes several months to complete, a Phase II trial may last from several months to two years, and a Phase III trial can last for several years. All told, the clinical phase of drug development lasts an average of around 95 months – nearly 8 years – according to the National Center for Biotechnology Information (NCBI).

Clinical trials are expensive, too, with the total cost depending on the number of participants and the complexity of the clinical trial protocol, among other factors. The most widely cited academic source on clinical trial costs, Key Cost Drivers of Pharmaceutical Clinical Trials in the United States, found Phase I costs ranging from $1.4 million to $6.6 million, Phase II from $7.0 million to $19.6 million, and Phase III from $11.5 million to $52.9 million, depending on therapeutic area.

A more recent study, drawing on data from seven major biopharma companies covering 726 interventional studies, reported median costs of $8.6 million for Phase II and $21.4 million for Phase III, with Phase III costs spanning $9 million at the 25th percentile to $44 million at the 75th percentile, according to Springer. The authors found that the number of trial sites, therapeutic area, and treatment duration explained 60–90% of cost variance.

Then there’s geography, a major challenge to overcome when conducting clinical trials. According to the NCBI, “Despite a high willingness to participate in clinical trials, only a small proportion of patients typically enroll. From a patient’s perspective, geographic barriers play a key role. A greater distance and travel time to a clinical trial site decreases desire and ability to participate. And more fundamentally, patients are typically treated at their most proximate healthcare center, which may not or may not be participating in a suitable trial.”

One technology being championed as a solution to these problems is telehealth. But just what, exactly, is telehealth? Can it really help expedite trials, reduce costs, and allow for a more diverse patient population to take part? And how did it even enter the conversation?

COVID Forces The Industry’s Hand

COVID forced the industry to adopt telehealth quickly, and most professionals were surprised by how well it worked. According to Clinical Leader, one fully decentralized Phase 4 breast cancer trial using telehealth, mobile nursing, and ePRO tools achieved a 96% patient retention rate – a roughly 30% improvement over traditional oncology trials. Results like this shifted a lot of skeptics into believers.

The patient access argument resonates deeply with trial professionals, especially those working in oncology or rare diseases. According to the NCBI, Stanford researchers found that integrating telehealth into a cancer trial alleviated financial and time burdens for participants who lived farther from the research center, particularly individuals who are underrepresented in clinical research. For a field that has struggled with diversity and inclusion for decades, this matters.

Experienced compliance professionals, according to the Association of Clinical Research Professionals (ACRP), welcomed the FDA’s 2024 final guidance that eliminated the requirement for local healthcare providers to be listed on a task log, which had received significant public pushback, a sign that the field was willing to push back and was heard.

Still, not everyone bought into the promise of telehealth, but the tension wasn’t about whether telehealth works; it was about when it was appropriate to use the technology and how rigid the rules should be.

According to ACRP, a key concern among compliance experts was that requiring too many DCT elements to be hardwired in written protocols reduced the flexibility that sites and patients actually need. The more prescriptive a protocol, the less willing patients and sites are to participate, undercutting the whole point of decentralizing.

There also was a digital divide problem with researchers noting that at least 25% of Americans lacked the digital literacy or device access needed to participate in video visits, according to Oxford Academic. This meant telehealth-centric trials could inadvertently exclude the very populations they’re designed to reach.

Today, most clinical trial professionals seem to view telehealth as a tool to be used selectively, not a wholesale replacement for in-person trials. The emerging consensus is to return to trial design fundamentals, but with the option to leverage modern technologies only when and if they genuinely benefit the trial, writes ACRP. There’s also ongoing frustration with navigating a patchwork of state telehealth laws, which creates compliance headaches when running multi-state trials.

In short, professionals are mostly converts, but pragmatic ones. The hype cycle has cooled into a more mature “right tool for the right trial” perspective.

Telehealth Is A Tool, Not A Trial Design

Telehealth, according to the Health Resources & Services Administration, is the use of electronic information and telecommunication technologies to support long-distance clinical healthcare, patient and professional health-related education, health administration, and public health. In the context of clinical trials, it is the use of digital communication technologies to conduct trial-related activities remotely, replacing or supplementing visits that would traditionally require a participant to physically come into a clinic or research site, according to the NCBI.

Importantly, telehealth is a tool, not a trial design. The two are related but not the same, and telehealth can be incorporated into virtually any trial model – fully traditional, hybrid, or fully decentralized – to varying degrees in the form of televisits, remote patient monitoring, electronic patient-reported outcomes (ePRO), and remote informed consent (eConsent).

Direct-to-patient services involve shipping investigational drugs directly to a participant’s home rather than requiring them to come to the site to pick up their medication, typically paired with telehealth visits to ensure proper dispensing oversight.

Televisits are the most straightforward: scheduled video or phone appointments between a participant and a site investigator or coordinator, used to assess adverse events, review a patient’s symptom diary, conduct a brief neurological assessment, or go over lab results. According to the FDA, whether a televisit can substitute for an in-person visit depends heavily on what the protocol actually requires – you can assess a patient’s mood or fatigue remotely, but you can’t examine a surgical site.

Remote patient monitoring involves wearables, sensors, or apps that passively or actively collect clinical data from participants in their everyday environment – continuous glucose monitors, ECG patches, actigraphy wristbands, or blood pressure cuffs that transmit readings directly to the trial database. According to the NCBI, this is often more scientifically valuable than a single in-clinic measurement because it captures real-world data over time rather than a snapshot.

According to the NCBI, ePROs are digital questionnaires pushed to a participant’s phone or tablet to capture how they’re feeling – pain levels, quality of life, symptom burden – without needing a site visit and have largely replaced paper diaries in modern trials.

Finally, eConsent) uses digital platforms to walk potential participants through the consent process – sometimes with embedded videos, comprehension checks, and electronic signatures – allowing enrollment to happen without an initial in-person visit.

How Telehealth Fits Into Different Trial Models

A traditional site-based trial can use telehealth without being a decentralized trial at all. A site might conduct all investigational procedures, drug administration, and primary endpoint assessments in person, but use telehealth simply to conduct a between-visit safety check-in, collect a patient-reported outcome, or assess whether reported symptom warrants an unscheduled visit. The trial’s fundamental structure hasn’t changed – it’s still site-centric – but telehealth is operating as a convenience layer on top of it.

A hybrid trial goes further, intentionally replacing some protocol-specified visits with remote alternatives while retaining in-person visits for procedures that require them. This is where telehealth becomes a structural component of the trial design rather than just an operational add-on.

A fully decentralized trial uses telehealth and remote technologies as the primary mechanism for conducting the trial, with little or no reliance on a fixed investigational site. These are the least common and face the most regulatory complexity.

Almost any trial can incorporate some degree of telehealth; the real question is which visits and assessments are appropriate to conduct remotely, given the protocol requirements, the intervention type, the endpoints, and the regulatory framework.

Sponsors and sites don’t need to commit to a fully decentralized model to capture meaningful benefits. Even modest integration, such as replacing one or two routine follow-up visits per participant with video calls, can significantly improve retention and reduce site burden at scale.

Whatever is done remotely, the FDA requires it to meet the same data quality, safety, and oversight standards as in-person activities. This is why the regulatory and compliance aspects of this remain genuinely complex, even when the technology itself is straightforward.

Inside The Numbers

The numbers that open this piece are sobering: nearly eight years to complete the clinical phase of drug development, Phase III costs that can push past $50 million, and a patient population that too often never makes it to a trial site at all. Telehealth doesn't solve all of that, but it addresses each problem in concrete, measurable ways.

On time, even modest telehealth integration compresses timelines at the margins, and in trials, margins compound. Fewer missed visits mean fewer protocol deviations. Fewer protocol deviations mean cleaner data. Cleaner data means faster review.

Remote safety check-ins catch issues earlier, reducing the lag between a reportable event and a sponsor response. And when eConsent allows enrollment to begin without an initial in-person visit, the time between a patient expressing interest and a patient being enrolled shrinks considerably.

On cost, the savings are largely structural. Site visits are expensive to operationalize – for the participant in travel time and burden, and for the sponsor in coordinator time, site overhead, and dropout-related delays. When routine follow-up visits are replaced with video calls, those costs don't disappear, but they are redistributed in ways that favor completion. Retention is where telehealth’s financial case is strongest: a patient who stays in a trial is exponentially less costly than one who drops out and must be replaced, or whose dropout compromises an endpoint entirely.

On geography, the impact may be the most significant of all. The patients least likely to enroll in a clinical trial have historically been those farthest from an academic medical center, which correlates strongly with rural populations, lower-income patients, and communities that have long been underrepresented in research. Telehealth doesn't eliminate the need to ever see a site, but it dramatically reduces how often that's required. A patient who would have declined participation because of a two-hour drive to a monthly visit may readily participate when that visit is a video call. That’s not just good for enrollment numbers; it’s good for the science, producing data that better reflects the population that will use the treatment.

The Bottom Line

None of this means telehealth is a universal answer. As this piece has argued, it’s a tool, one that works best when applied selectively, matched carefully to the protocol, the intervention, and the patient population. But used well, it targets the three most persistent inefficiencies in clinical research with a precision that few other innovations can match.

That said, what do sites and patients think about telehealth? Find out in the second part of this two-part series, coming March 4.