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Decentralized Clinical Trial Myths

Debunking DCT Myths, Part 1: Tackling Misconceptions about Participation

In our conversations with trial sponsors, ObvioHealth tackles many decentralized clinical trial (DCTs) myths: They’re less safe, they’re always fully virtual, the data isn’t trustworthy, and so on. These misconceptions come packed with consequences—they have the potential to hinder our industry’s evolution by keeping sponsors from designing optimal studies that deliver better data with higher retention and compliance rates.  

It's time to debunk common DCT myths once and for all.  

In this two-part blog series, we’ll be tackling six of the most persistent myths about DCTs, uncovering the realities that are advancing the industry. First, let’s address misconceptions surrounding the human element of clinical trials—how DCTs affect participant burden, study engagement, and patient safety.

Myth: Decentralized clinical trials aren’t user-friendly.

Fact: DCTs bring studies directly to patients.

The industry has a lingering perception that patients can’t use the technology involved in DCTs. This myth is outdated, especially because the pandemic has rapidly accelerated digital health adoption. DCTs are becoming more mainstream by the day.

It’s true that new tools typically involve a learning curve. But, participants deserve credit for being willing to embrace them. In ObvioHealth’s urinary incontinence study, people ages 65 or older represented 23% of our 350 participants. Women 65 and older complied with the study protocol at a much higher rate than younger women: The 65-and-older cohort had a device adherence rate of 79% vs. 59% in the younger population. Read more on clinical trials in older adults.

In fact, because DCTs bring studies directly to patients in the comfort of their homes, they can be more participant-centric than traditional site-based studies. The convenience of fewer in-person visits can help study teams recruit a more diverse patient population, including groups that are traditionally underrepresented in clinical research.

Myth: Decentralized clinical trials remove human interaction.

Fact: DCTs support human interaction.

In a well-designed decentralized clinical trial, technology augments human interaction but doesn’t replace it. Effective DCT teams consider every touchpoint in the participant journey and offer support throughout each phase to create patient-centric clinical trials.  

For example, ObvioHealth’s virtual site team—our Clinical Oversight And Coordination Hub (COACH) team—humanizes clinical trials by providing participants with consistent interaction and support. COACH team members connect with patients using several different methods, from our chat platform to in-app notifications and phone calls. The integration of our virtual site team has been so successful that four of ObvioHealth’s recent trials had 100 percent of the participants chatting with the COACH team.

It’s no surprise that participants often prefer this type of engagement—the proof is in the patient testimonials. Here’s what two patients had to say about the convenience of our DCT studies:  

  • “I had two different jobs. I was constantly on the go, and I wasn’t always at home, so it was easy. I could just get on my phone, do it real quick and go on my way.”
  • “It was convenient. I could reach someone even though there was a time difference.”

Easier access to study teams translates into higher retention, engagement, compliance, and data collection rates. This is effectively demonstrated in one of our recently conducted clinical studies, which was designed to assess the efficacy of an FDA-approved Class II medical device to treat stress urinary incontinence and stress-predominant mixed urinary incontinence in women. Regular interactions with our COACH team engaged patients throughout the trial, resulting in an 89% retention rate and a 93.5% ePRO compliance rate. 

Lear about some Decentralized Clinical Trial Myths with ObvioHealth

Myth: Decentralized clinical trials aren’t safe.

Fact: DCTs add more safeguards to clinical trials.

The traditional clinical study paradigm brings participants on-site at regular intervals to interact with the study team. However, patients may not recall symptoms accurately by the time they visit the doctor—and questions or concerns may slip through the cracks.

Virtual site teams remain on call throughout the study, available to answer questions, address concerns, and provide support to patients as and when they need it. With the technologies and digital instruments used in DCTs and hybrid trials, patients can report a change in health status in real-time for immediate follow-up. This means patients can relay their symptoms as they experience them, and virtual site teams, such as the COACH team, immediately receive the data. Platforms can be programmed to alert the virtual site team to potential adverse events.

Maintaining open lines of communication, in addition to the transfer of real-time data, directly improves patient safety and data quality.

But, wait … there’s more on decentralized clinical trial myths

By streamlining access to study teams and providing ongoing support, DCTs can reduce the participant burden while also improving study engagement.  

But, we’re not done rebutting DCT myths just yet. Some of the most nagging misconceptions about DCTs are around study design, data accuracy, and FDA acceptance. Stay tuned for our next blog post, where we’ll examine these topics and separate fact from myth.