Decentralized Clinical Trials:

You Don’t Have to Do Everything, You Just Have to Start.

Dr. Oakley-Girvan received her Ph.D. from the Stanford University School of Medicine and her M.P.H. from Tulane University School of Public.

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Decentralized clinical trials (DCTs) are transforming medical research, bringing powerful benefits to study teams and patients alike. DCTs rely on user-friendly technologies, like smartphones, tablets and wearables, to enable patients to participate in clinical trials from the comfort of their own homes, rather than traveling to study sites. With advantages like faster and more targeted patient enrollment, better patient diversity, stronger patient engagement and retention, improved clinical safety, cleaner data and tremendous cost savings, it’s no wonder that there is excitement about this important innovation.

The good news is that decentralized clinical trials — also known as virtual, remote or digital clinical trials — can be adapted to best serve the patient population, condition or therapy you’re investigating. In fact, best practices suggest taking a case-by-case approach to implementing DCTs. While some DCTs are almost fully remote, the majority still employ a hybrid model, opting to implement only those digital components that make sense for a given study, whether that’s recruitment and screening, consent, data capture, patient monitoring, data analysis, or some combination of these. You don’t need to take an all-or-nothing approach.

Easing into DCTs

Even if your existing processes still work okay, they are likely being challenged in the current environment caused by the COVID-19 pandemic. Teams that don’t adapt will be left behind. That’s not to say you need to convert your long-established practices to a digital platform overnight. In many cases, clinical trial software is modular and scalable, so it can be tailored to be more of a hybrid approach based on your specific needs. (In fact, in 2020, only 30 percent of our clients that initiated DCTs used all the available modules together.) Most digital trial tools also address data privacy concerns, meeting both HIPAA and GDPR requirements, and are 21-CFR Part 11 compliant. And they bring a patient-centric focus to clinical trials. Starting with just one or two electronic tools can vastly streamline your work while you build your digital proficiency at a pace that feels comfortable. So what’s stopping you?

When you’re ready to begin transitioning to a digital platform, the first critical step will be to conceptualize your current workflows and how they may change with decentralization. Humans are naturally resistant to change, and if you can identify pain points early — and have strategies to overcome them — getting buy-in from your team will be substantially easier. It’s important to determine the one or two components that will bring the greatest value to your study with the least amount of disruption. Most commonly, these include:

  • Digital & DCT Screening. Digital screening tools enable teams to reach a much broader and more clinically targeted patient population, so you can meet your enrollment goals faster. Patients like the convenience of being able to complete the electronic screening forms anywhere, using any device. And screenings can incorporate almost any kind of patient assessment, whether that includes imaging, bloodwork, telemetry, or patient questionnaires.
  • TeleConsent. When patients use an eConsent product, they demonstrate improved knowledge transfer and engagement from the start. If questions arise, patients can seamlessly connect to a physician or other health care provider. What’s more, the consent can be completed either on site or remotely. Either way, it eliminates hours of administrative time so site staff can focus on research. When combined with multi-language support and wet-ink functionality, eConsent can be used in studies worldwide. The FDA issued guidance for using eConsent back in 2016, making it one of the easiest tools to adopt today.
  • Televisits. Patients find that telemedicine helps recreate a supportive office experience without the hassles of travel, parking or sitting in a waiting room full of sick people. Video-based consultations enable patients to discuss any symptoms or concerns they may have with their health care provider in a fraction of the time that a site-based visit would take. At Medable, we’ve found that Televisits also improve patient adherence to protocol by as much as 15 percent.
  • Electronic outcomes assessments. When it’s time for patients or staff to complete outcomes assessments, eCOA and ePRO solutions can get the job done swiftly and intuitively. They can capture outcomes in real time, whether performed on site or remotely, and provide clinical guidance in making decisions around adverse events, dosing and efficacy, and continued patient inclusion or exclusion. When combined with Televisits, eCOA and ePRO provide teams with exceptional insights. At Medable, patients report satisfaction with using ePRO at a rate exceeding 90 percent.

As the recognized leader in DCTs, Medable’s suite of products can help you move forward at a pace that meets your needs. So if you are curious to find out more or are ready to take the first step toward digitizing your study with clinical trial software, contact Medable for demos and custom solutions.