Digital transformation is reshaping nearly every industry, and clinical trials are no exception. As technology plays a bigger role in healthcare, patients are demanding more access to medical research. It’s not just patients who are asking for more: Medical professionals, researchers, and pharmaceutical companies all want to improve quality, efficiency, and access to clinical trials.

The clinical trial industry has had to adapt quickly to meet these needs while mitigating risks and maintaining participant safety. Fortunately, decentralized clinical trial platforms have emerged as a key solution to the challenges associated with traditional clinical trial management systems.

In this post, we’ll explore how decentralized research platforms are revolutionizing the life sciences industry and changing the landscape of clinical research.  

Discover the benefits of decentralized clinical trials and why patients prefer them.

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Key Decentralized Clinical Trial Platform Takeaways:

• Decentralized clinical trial platforms improve access, quality, and efficiency for sites and patients alike by delivering richer and more accurate data, supporting compliance, and easing the participant burden.
• Decentralized research platforms simplify the consent process and clarify participants’ obligations.
• Although not every trial can be 100% virtual, decentralized components can be implemented in most cases.

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Decentralized Clinical Trial Platforms: A Brief Overview

Decentralized clinical trial platforms are web-based, cloud-based software solutions that support clinical trial management, reporting, and data collection. These decentralized research platforms also enable smooth trial management and delivery with tools such as participant pre-screening, eConsent, multi-factor identity verification, virtual training, live chat, electronic patient-reported outcomes (ePRO), and electronic clinical outcome assessment (eCOA) tools.

The best decentralized research platforms offer a modular, end-to-end framework that spans the entire clinical trial journey. Within this cost-effective framework, sponsors can selectively adopt virtual elements that fit the study’s needs and goals.

Flexibility is key because not every clinical trial is a perfect fit for complete decentralization. For instance, some clinical trials involve patient MRIs, which require a visit to a clinic with the necessary equipment.

The ability to maintain in-person components while streamlining other aspects of clinical trials is the beauty of decentralized research platforms. Sponsors can retain necessary site-based tasks while incorporating DCT elements such as enrollment and onboarding decentralized research participants.

In fact, most clinical trials can implement a “hybrid” approach that blends site-based and virtual components. It’s no surprise that trials using decentralized methods are expected to rise to 28% in 2022, compared to 2021.

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Improving Access, Quality, and Efficiency in Clinical Research Through Decentralized Clinical Trials Platforms

While improving the access, quality, and efficiency of patients and study teams is a longstanding priority, the constraints of centralized clinical trials have hindered progress in this area. However, the rise of decentralized research platforms is changing the equation—empowering sites and participants alike by:

• Increasing transparency around the study protocol and goals
• Recruiting a diverse participant pool that reflects the treatment population
• Removing or minimizing barriers to inclusion, such as travel requirements
• Ensuring that candidates fully understand the commitment involved in participating
• Streamlining data collection, including the submission of BYOD ePRO (electronic patient-reported outcomes)
• Supporting patients in real time through convenient access to the study team

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Enhancing Diversity, Equity, and Inclusion in Recruitment

Recruiting a diverse pool of participants is an ever-present challenge for sponsors, a concern that only grew during the COVID-19 pandemic. Trial participation by people of color fell drastically during 2020. For years, the FDA and industry leaders have called on clinical trial teams to better meet the needs of diverse patient populations. In fact, in April of 2022, the government body released draft guidance to improve enrollment among underrepresented racial and ethnic subgroups.

Decentralized clinical trial platforms are helping to narrow the gap in participation and promote diversity, equity, and inclusion. A DCT approach empowers contract research organizations (CROs) to recruit, enroll, and support participants right where they are.

Bringing trials directly to patients helps to ease the burdens of scheduling, travel, and social distancing. Removing these barriers gives traditionally underrepresented groups greater agency over their lives and their health.

In addition, clinical trial teams can use decentralized clinical trial platforms to conduct targeted recruitment, enrollment, and onboarding. These cost-effective strategies enable sponsors to reach and engage new populations.

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Increasing Participant Access Through Decentralized Clinical Trials

The flexibility offered by DCT platforms allows a broader pool of participants to access clinical research. For example, teams can overcome language barriers using translation technology or virtual study teams, rather than recruiting translators for various languages at each site.

Likewise, patients with mobility limitations can participate without the burden of visiting a major hospital or university. And, study teams can obtain data from rural populations without participants needing to travel for multiple hours.

DCTs can also incorporate real-time feedback from participants and study teams. For instance, if multiple participants find a specific phrase confusing, the study team can find out right away and have a chance to adjust course before it’s too late.

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Maintaining Patient Engagement and Supporting the Patient Experience

Maintaining patient engagement is one of the most critical, yet challenging, aspects of clinical trial management. Here again, decentralized trials and cloud-based software solutions can foster engagement, improve the patient experience, and drive patient retention.

Study teams can use a decentralized research app to complete virtual visits with participants, similar to a home health model. Using digital technologies, teams can check in with participants who fail to report data within a specified timeframe or otherwise lag in expected participation. Research teams can also leverage decentralized trial apps to send automated reminders of upcoming study tasks, such as diary or questionnaire entries.

Decentralized research platforms also support rich data collection by allowing patients to report their symptoms in real time. Rather than having to fill out a bladder diary at the end of the day, for example, clients can log their restroom visits with the simple touch of a button. This real-time symptom tracking has two key benefits: raising compliance levels and minimizing the risk that forgetfulness or inaccuracy may skew important medical data.

Modern technological advances have also enabled decentralized trials to detect changes in patient status by using wearable sensors to monitor vital signs. Gathering rich data in real time allows sponsors to catch adverse events more quickly, supporting participant safety.  

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How Decentralized Trials Support Informed Consent in Clinical Research

Informed consent is vital in every sphere of medicine. During a clinical trial, it’s essential that participants understand all the known risks and benefits of the drug or device being tested—and that unknown side effects could arise during the trial. In fact, inadequate informed consent is among the trial failures most frequently cited by FDA inspectors.

Within a DCT model, eConsent forms can present information in brief, easily digestible blocks of text, requesting that a patient confirm their full understanding before moving on. Animated videos and self-guided in-app and online demonstrations can also clarify and visualize complex medical concepts, making them easier for patients to understand.

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Maximizing Participant Ease Through Decentralized Research

There’s no debate that the COVID-19 pandemic has transformed the way many patients receive healthcare—with many patients quickly adapting to telehealth and other forms of care delivery.

In an era when patients are increasingly receptive to using technology to manage their healthcare, decentralized clinical trial platforms empower patients to participate in groundbreaking trials from the comfort of their homes.

Decentralized research platforms are particularly ideal for exploring traditionally “taboo” topics in research areas like urogynecology and reproductive health. While patients might be reticent about certain conditions in person, engaging over a smartphone can put them at ease.

The human element is still key in decentralized clinical trials. Patients can engage with virtual study teams through video chat, telephone, or in-app chat. Team members can even reference prior chat sessions to use words that patients prefer, helping participants feel safe and heard.

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Driving Better Data with Decentralized Clinical Trials

Supporting patients goes hand in hand with producing quality data. Decentralized clinical research apps unlock real-world data for the life sciences industry by streamlining data collection, management, reporting, and visualization. Along the way, teams can detect changes in participants’ vital signs in real time, improving data accuracy and delivering meaningful outcomes.

As a result, clinical trial teams can not only generate more personal data, but also better data. This is a major benefit for trial providers and life sciences companies—especially those conducting preclinical studies or researching rare diseases, each of whom place a high premium on data quality.

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Final Thoughts on Decentralized Clinical Trial Platforms

The demand for access, quality, and efficiency in clinical trials will only continue to grow—and so will the industry’s need for quality data, streamlined processes, and meaningful outcomes. With the emergence of decentralized clinical trial platforms, sponsors and participants can adopt flexible, modular, cost-effective solutions that bridge these gaps and deliver greater value across the board.

ObvioHealth is an end-to-end virtual research organization (VRO) that has enabled end-to-end and hybrid clinical trials in 16 therapeutic areas across 28 countries.

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