When Virtual Trials Are Not the Answer

Next to cost, patient recruitment, enrollment, and retention are top concerns for sponsors, sites, and others involved in clinical trials.

Will virtual clinical trials ease these challenges and reduce the 90% failure rate? Not yet.

What do we mean by virtual clinical trials?

Virtual clinical trials, or siteless clinical trials, use videoconferencing, wearable technology, mobile apps, and similar tools to solve patient-related challenges. Instead of driving to a site multiple times during a study, patients can send and receive information and medications remotely. They can get screened or chat with their study team via phone or video and complete surveys using an app.

When used successfully, the virtual clinical trial model promises to enroll more patients faster, improve patient retention, and reduce costs. It also gives patients a way to participate when they may not have the time or means to visit a physical site.

For all their perceived advantages, a virtual model doesn’t suit all studies. In fact, a start-to-finish siteless model only works in limited situations.

When not to conduct a site-less trial

Much like doctors can’t treat all patients by telemedicine, not all clinical trials can use remote technology. A virtual approach is not the answer if any of the following apply:

• The clinical trial requires in-hospital attention or equipment. For example, a study examining a new type of radiation therapy or biologic would require close monitoring from a specialist due to high risk of morbidity and toxicity. Cancer studies measure outcomes via diagnostic imaging; which, unless a patient has their own CT scanner, would require in-person visits.

• It’s a phase I study. Phase I clinical trials aim to find the best dose of a drug with the fewest side effects. To understand how the body metabolizes the drug, physicians have to take regular blood draws at specific intervals. Because of the highly controlled environment required, sponsors need a physical site.

• The study will be conducted in countries that don’t support remote patient engagement. The FDA accepts eConsent as a valid patient consent method. At present, the EU does not. In addition, not every country allows central pharmacies to ship drugs directly to patients.

When does it work?

A virtual clinical trial can only work in studies that rely heavily on patient reported outcomes (PRO) and quality of life measures. Studies in dermatology and other “light” indications where the drug or device isn’t life-threatening or invasive could be conducted virtually.

AOBiome, a Boston biotech focused on improving health through products that restore ammonia-oxidizing bacteria, recently conducted a siteless phase 2b clinical trial. The study, designed to assess safety details and determine the effectiveness of AOBiome’s in-development acne treatment, started by recruiting patients through social media and online ads. It continued by conducting screening and consent by phone. For the duration of the study, patients reported treatment effects, submitted photos of their acne, and asked questions, all using an app on loaned iPhones.

At the conclusion of the study, AOBiome reported positive safety and efficacy data. It also enrolled 372 patients in seven months—about half the time of a typical, similar trial. Also, the study recruited 41% minority patients, partly because those patients could participate no matter where they lived. AOBiome president and CEO Todd Krueger said, in an article for Undark, dropout rates were “lower than expected,” compliance was “better than expected,” and the trial was “cheaper to administer” than a traditional trial.

Challenges of virtual trials

Of the 238,000-plus clinical trials registered on ClinicalTrials.gov, very few are, or can be, conducted virtually. Multiple factors have led to slowed adoption.

• Computer literacy. Studies show about 77 percent of Americans own a smartphone, but many lack basic computer literacy. Organisation for Economic Co-operation and Development (OECD) found only one in ten Americans age 55-65 could complete a task like filling out an online form using an app. Recruiting older adults with low computer literacy could impact trial data and patient retention.

• Data integrity. Without data integrity, research becomes worthless. The technology needs to work to collect meaningful data at the right time. Patients also have to understand how to use devices, apps and web portals to properly report treatment effects, side effects and other measures. Data blinding and data management may also require different processes to maintain integrity.

The hybrid alternative

Many clinical trials have achieved some of the benefits of virtual trials while still maintaining physical sites. Sponsors of rare disease studies can enroll patients remotely, which allows them to target a wider geographical area.

Other therapeutic areas can allow patients to report quality of life levels using a mobile app while visiting a physical location for more in-depth assessments. As sponsors gradually test new models, we expect to see an increase in hybrid trials.

At Biorasi, we’re ahead of the curve when it comes to remote technology. Our clinical trial technology and program management platform, TALOS^®, integrates with most databases to gather lab results, outcomes data, assessment results, and other data in one place. And because of our strong regulatory experience, we know how to move a study to completion with regulatory agencies worldwide.

Conventional, virtual, or hybrid, we’re ready to go any time. To find out which approach best suits your study, talk to our clinical team.