A Necessary Evolution for Clinical Research
Historically, clinical trials have been overly burdensome for patients. This inconvenience has resulted in slow recruitment and poor retention, leaving sponsors with suboptimal data, bloated budgets, and extended timelines.
Fortunately, the emergence of decentralized clinical trials is transforming the traditional approach to research, making trial participation easier and safer, which in turn is resulting in more efficient and effective data collection for sponsors.
FDA Definition: The decentralization of clinical trial operations where technology is used to communicate with study participants and collect data.
While this definition is quite broad, it does highlight the growing role of technology in trials. As is always the case with technology, this can have both positive and negative repercussions.
Remote study subjects follow the protocol from the comforts of their homes – perform the study tasks, fill out their daily diaries – and this real-world data is almost instantly available to trial monitors.
Because the patients' data is accessible so quickly, the study team can respond to operational challenges, meaning researchers can often avoid potentially time-consuming, expensive detours.
The risks of decentralizing a clinical trial arise when technology is decoupled from human understanding and empathy. This happens most often when a questionnaire or diary is 'digitized' without being adapted to a specific context or device.
DCTs can also pose problems when participants do not have easy access to the clinical team to ask questions. When carefully designed and executed, both of these issues are avoidable, and decentralized clinical trials can make life easier for all involved.
The benefits of decentralized clinical trials were well summarized in 2018 by then-FDA commissioner Scott Gottlieb who highlighted the use of digital technologies to "bring clinical trials to the patient, rather than always requiring the patient to travel to the investigator."
By narrowing this gap, digital technologies make research more accessible to participants and facilitate data collection that better represents the 'real world.' It's important to note that DCTs are conducted much in the same way as traditional trials, overseen by a CRO (or more accurately a VRO: Virtual Research Organization) that centralizes and coordinates all aspects of the trial remotely. (Read more about Remote Monitoring Clinical Trials.)
The most significant difference between a site-based and a decentralized trial is that data capture for the DCT most often occurs outside of the site visit.
Until a year ago, many researchers believed that the cons of DCTs outweighed the pros. In part, this was due to risk aversion in the industry and a reluctance to try new methods. All of that changed with the onset of the pandemic.
Site Closures Expedite Change
Covid-19 significantly affected the US$ 60bn clinical trial industry, initially closing 70 percent of the sites in Europe/US. As the novel virus spread, researchers understood the need for physical distancing and remote data collection.
Hospitals and clinics wanted to minimize their staff's exposure to a highly infectious disease, and patients wanted to avoid leaving home for multiple visits to medical facilities. Site visits posed increased risk.
Emergence of Telehealth
Adoption of telehealth platforms skyrocketed, from 11% of US consumers using them in 2019 to more than 76% using telehealth to replace canceled healthcare visits only a year later.
The accelerated embrace of remote HCP visits had a knock-on effect on clinical trials. The pandemic has forced researchers to reduce site visits and to accept DCTs as a new way to collect data while ensuring patient and researcher safety.
Telemedicine and Home Health: Underutilized in traditional research, virtual visits make clinical studies easier for patients by curtailing travel and time spent in the waiting room. Home health visits by an HCP can also achieve this.
Electronic Clinical Outcome Assessment (eCOA): eCOAs allow for digital reporting of health-related outcomes, both from patients and HCPs.
Electronic Patient-Reported Outcomes (ePRO): ePROs give patients the ability to report health outcomes (symptoms, side effects) through a digital device. Clinical trial platforms like the ObvioHealth App bring the study out of the lab/clinic and onto Android/Apple devices. Patients can report outcomes via digital questionnaires, patient diaries, etc.
Electronic Clinician-Reported Outcomes (eCLinRO): HCPs input data directly from the source into a centralized database. This can be accomplished via customized dashboards that do away with the need for paper-based methods.
Device Integration: Devices allow researchers to collect measurements both in the real world and in real-time. For instance, an at-home EKG device can be placed on a participant's chest, where it continually captures heart health data as the patient goes about his daily activities.
In figure 1, a lab visit is required only at the beginning and end of the trial. Data capture and outcomes measurement is conducted through a smartphone app between those visits.
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1) Diverse Recruitment & Study Access
Because they are remote, DCTs remove geographic barriers to participation.
Patients living too far from a study site (i.e., rural locations) can participate virtually without the need to travel. For researchers, this widens the participant pool, resulting in faster recruitment times, more diverse study populations, and more complete data sets.
Example: Decentralized Interventional Research Study - GI Tolerance
2) Fewer Gaps in Data
One of the critical limitations of on-site reporting is the reliance upon participants to fill in their diaries diligently.
Giving patients the ability to download an app on their own mobile devices to report symptoms the moment they are occurring is a better way to capture real-time experiences and perceptions. Having ePRO on a participant's smartphone allows the researcher to send out daily reminders to participate in study activities. Since people carry their phones with them all the time, these reminders positively impact participant compliance and retention. The seamless integration of digital devices (i.e., wearables) gives researchers access to more regular and passive data collection. Increasingly, this data can be transmitted instantaneously to a central server, eliminating the need for patients to note down any readings.
Example: Decentralized Interventional Research Study - COVID-19 Treatment
3) Increased Patient Centricity
Quality data and patient engagement are intertwined.
When patients are engaged with a study, drop-out rates are typically lower, improving data collection and data quality. The decreased travel and wait times in decentralized clinical trials also enhance patient satisfaction.
Example: Employing a patient-centric protocol design to keep reduce dropout, increase compliance, and better data.
4) Reduced Cost, Efficiency, and Speed
Digital data collection can significantly reign-in the costs (operations, travel, etc.)
A DCT can shorten timelines at several points during the trial. Digital recruitment makes it easier to find cohorts more quickly and pre-screen/screen them more efficiently. The dematerialized nature of a decentralized protocol design also allows sponsors to pivot quickly in the face of unforeseen recruitment challenges.
Example: Pivoting recruitment for a dermatological clinical trial
5) Safety – AE/SAE immediate intervention, real-time alerts
Because DCTs allow patients to input data remotely, monitors can review inputs in real-time.
This means adverse events can be spotted quickly, and the study PI can react accordingly. In traditional trials, AEs often go unnoticed until a scheduled site visit with an HCP – possibly days or weeks from when the event occurred. In DCTs, patients respond to a daily question to determine whether their medical status has changed. If affirmative, the system asks further questions to capture the scope of the issue. A virtual clinical study team can then follow up with the person via email, phone call, or chat to determine whether an adverse event occurred and create an electronic case report.
Example: Catching an AE in Real-Time
2020 was a transformative year for DCT’s. Yet, the decentralized revolution has only just begun.
Patients and trial sponsors are starting to understand the benefits of virtual research, and soon decentralized studies will be commonplace. Pioneering startups like ObvioHealth will continue to push the virtual boundaries of health research, innovating new ways to solve the industry’s most significant pain points (read more about Virtual Clinical Trials).
For example, AI can help reduce human error in scoring or rating skin blemishes. Machine learning can understand and ultimately predict which behavioral traits result in the highest protocol adherence. Health is a category in which risk aversion is the norm. It is also a space rife with ideas and hungry for progress.
The Decentralized clinical trial is an example of an innovation that took longer than it should have to reach a tipping point. But now that we are here, we believe it will become the norm, bringing better health for all.
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