Telehealth In Clinical Trials: What Sites And Patients Think

By John Oncea, Editor

Sites and patients have complicated views on telehealth in trials. Here’s what the evidence shows about who benefits, who bears the burden, and where the limits are.

In part one of this two-part series, we looked at what telehealth is, how COVID hastened its arrival, and how it is being used across traditional, hybrid, and decentralized trial models. Here, we examine how sites and patients have responded to the technology – the benefits, the frustrations, and the cases where it works best and least well.

Is Telehealth Worth The Cost

Site opinions are genuinely mixed and tend to depend heavily on the site’s size, resources, and experience with decentralized models. Larger academic medical centers and dedicated research sites with robust infrastructure tend to be more receptive because they have the IT support, staffing, and sponsor relationships to implement telehealth without absorbing excessive burden.

According to the National Center for Biotechnology Information (NCBI), smaller community sites and independent research centers often report that telehealth creates more work than it saves, at least initially, because they are being asked to adopt new platforms, train staff, navigate licensure questions, and troubleshoot technology issues for patients, frequently without additional compensation from sponsors to cover these costs.

These costs are sharper than many sponsors appreciate. According to Clinical Leader, a Society for Clinical Research Sites (SCRS) site landscape survey found that 80% of sites have less than six months of working capital in the bank, and 23% report that invoices are routinely more than 90 days overdue.

Into this environment, sponsors are asking sites to absorb new technology, training, and workflow costs that hybrid and decentralized trial designs require. In addition, 73% of sites approached to participate in hybrid trials have found that such studies involve more technology, training, resources, and time than sponsors have budgeted for.

A recurring frustration is that telehealth is sometimes presented as a cost-saving measure for the sponsor rather than an operational improvement for the site. When remote visits reduce the per-visit reimbursement without proportionally reducing site workload, sites can end up worse off financially as coordinators still spend time scheduling, troubleshooting connectivity issues, chasing patient-reported data, and managing protocol deviations that arise from the looser structure of remote visits.

Disrupting Relationships

There is also a concern among experienced site staff that telehealth can erode the investigator-patient relationship. Researchers writing in NPJ Parkinson’s Disease note that in-person visits surface information such as a patient’s physical appearance, their affect, subtle signs of adverse events or non-adherence simply don’t come through on a video call. This is not a trivial concern from a safety and data quality standpoint. A 2022 ASCO Post piece drawing on Yale Cancer Center’s pandemic experience confirmed that video visits allowed only limited assessment of overall appearance, distress level, skin changes, and cognition – useful, but meaningfully less than what an in-person encounter provides.

Technology fit-for-purpose is a related and underappreciated problem. As one clinical research coordinator told The Conference Forum, “For any sponsor reading this, be very mindful of the technology you’re asking us to use. Whether you realize it or not, you’re asking us to teach it to an older population and serve as their tech support.” When devices are not fully ready for deployment – difficult to read, hard to navigate, or poorly integrated with existing EDC systems – the burden falls on coordinators, not sponsors.

According to the Parkinson’s Foundation and the Parkinson Study Group, implementation also has been slowed by variations in state licensure requirements for telehealth, inconsistency among IRBs, and the absence of field-wide minimum standards for safety and data security on telehealth platforms. Sites that had already developed telehealth SOPs were able to adapt quickly; those that hadn’t faced significant delays.

That said, sites that have successfully integrated telehealth into hybrid models generally report real benefits in retention and scheduling flexibility, and many view remote capabilities as increasingly necessary to remain competitive for sponsor contracts as DCT-friendly protocols become more common.

Where Telehealth Works And Where It Doesn’t

Some trial types are better suited to telehealth than others, and the distinction matters for protocol design. Chronic disease management trials are among the strongest candidates, as conditions like diabetes, hypertension, heart failure, COPD, and asthma require long follow-up periods with routine monitoring – blood pressure readings, symptom questionnaires, and medication adherence tracking – all of which can be managed remotely with consumer-grade or medical-grade devices, according to American Family Physician.

Psychiatric and behavioral health trials are also a natural fit, since the primary assessments – structured interviews, validated rating scales like the PHQ-9 or MADRS – can be administered effectively over video, according to the NCBI. This is particularly relevant for depression, anxiety, PTSD, and insomnia trials, where stigma or symptom severity may actually make in-person attendance harder for participants.

According to the NCBI, rare disease trials benefit enormously from telehealth because eligible patients are often geographically dispersed, and for whom frequent travel is genuinely not feasible. Oncology trials, particularly those in later lines of treatment or supportive care, can leverage telehealth for between-cycle check-ins, quality of life assessments, and adverse event monitoring, writes ASCO Post.

Post-market Phase IV and long-term follow-up studies are especially well-suited because the intervention is established, the safety profile is known, and the primary need is sustained data collection over months or years – a lower-risk profile that makes regulators more comfortable with reduced in-person oversight. Observational and registry studies, where no investigational intervention is being administered, can often be conducted almost entirely remotely.

First-in-human Phase I trials are a different matter. They require close clinical supervision, pharmacokinetic blood sampling at precise time points, and immediate access to emergency care, making them largely incompatible beyond peripheral touchpoints with telehealth beyond peripheral touchpoints. Similarly, trials involving infused or injected biologics, surgical interventions, or complex imaging endpoints like MRI or PET scans will always require a physical site component.

Scientific and regulatory constraints also apply broadly. As NPJ Parkinson’s Disease notes, many trials require data collected under tightly controlled, standardized conditions. A scale validated for in-person administration may not have equivalent psychometric properties when delivered over video – a scientific justification problem that sponsors may not want to navigate.

Regulatory and licensure complexity is a practical deterrent as well, particularly for multi-state or international trials, where investigators are generally required to be licensed in the jurisdiction where the patient is located at the time of a telehealth visit.

The most pragmatic approach for most sites today is a hybrid model – using telehealth to handle routine visits, safety check-ins, and patient-reported outcomes while reserving in-person visits for procedures that genuinely require them. This preserves scientific rigor while capturing the operational and retention benefits that telehealth offers.

What Patients Think

Patient preference is more heterogeneous than the dominant narrative suggests – an underappreciated issue in the decentralization conversation. Telehealth is widely framed as patient-centric because it reduces travel burden, but this assumes that travel burden is the primary concern for all patients. It isn’t.

The data on patient satisfaction with telehealth is generally positive but nuanced. A 2022 survey of U.S. adults published in JMIR Human Factors found that among those who had experienced telehealth, 70.8% reported being satisfied or very satisfied with telemedicine visits. Research from the American Cancer Society Cancer Action Network found that 94% of cancer patients and survivors said their issues and questions were addressed well in telehealth visits. These are meaningful numbers. But satisfaction with telehealth is different from preference for it.

A mixed-methods study of 1,226 patients published in Springer Nature found that despite the numerous benefits of telemedicine, the majority of patients still exhibited a preference for in-person visits. Reasons included more accurate diagnosis, more thorough physical examination, and – critically – a greater sense of trust and peace of mind. As one participant put it, “Personally, seeing a physician in person brings me a sense of peace that outweighs a faster recovery, as I trust their in-depth understanding of my condition leads to a more accurate diagnosis.”

For some patients, particularly those with serious or life-threatening illnesses, the clinical trial visit is a primary point of medical contact. They may not have a robust relationship with a primary care physician, or their condition may be managed almost entirely through the trial. Coming to the site gives them face time with a medical team, a physical examination, and a sense that they are being closely monitored. Remote visits can feel like a reduction in care rather than a convenience.

Trust is a particularly important dimension. A qualitative study of older adults with chronic kidney disease, published in PubMed, identified four overarching themes in patient and clinician perceptions of telehealth: inconsistent quality of care, patient experience and engagement, loss of connection and mistrust, and disparities in access. Some patients, particularly those from communities with historical reasons to distrust medical institutions, may paradoxically feel more comfortable with in-person oversight. Fully remote or heavily decentralized designs can feel less transparent to these patients, not more accessible.

There is also a demographic reality that trial designers need to account for. Research published in PubMed found that patients aged 65 and over were significantly less likely to choose telemedicine than those aged 18–44, and that technology access – measured by neighborhood internet availability – was a statistically significant predictor of telehealth uptake. A trial that leans heavily on telehealth may inadvertently exclude the very populations it is meant to study, introducing selection bias and limiting generalizability.

The broader point is that trial designs that optimize heavily for telehealth without accommodating participants who prefer in-person engagement risk alienating a meaningful portion of enrolled participants and potentially introducing differential dropout that biases results. As a narrative review of telemedicine in decentralized research published in PMC notes, trust, communication, and attitude are critical for engagement in clinical trials, but are challenging to convey without in-person visits – and there is a reasonable assumption that the need for virtual support and interaction is higher in decentralized settings precisely because that in-person foundation is absent.

The most thoughtful trial designs treat telehealth as an option to be offered rather than a default to be imposed. That requires sites to have the flexibility and staffing to support both modalities simultaneously, which itself adds operational complexity, but which is increasingly the cost of running trials that are both scientifically rigorous and genuinely accessible.