Clinical trials are evolving rapidly. Driven by technological advancements, there is a growing need to make studies more patient-centric while maintaining rigorous standards in clinical research. The term Decentralized Clinical Trials (DCTs) has gained significant traction during this evolution, and for good reason. The Tufts Center for Study of Drug Development 2022 report found that using DCT methods in Phase II clinical trials can boost the average value per drug by $8.6 million, nearly a five-fold return on investment (ROI). Likewise, a 2020 Tufts study indicated that DCTs can decrease trial duration by 23.7%1.
However, as the industry has embraced DCTs, the umbrella term “DCT” has become too broad, grouping very different decentralized elements—ranging from digital health technologies and telehealth visits to home-based and point-of-need trial activities—under a single label.
From our perspective on the frontlines of clinical research, this generalization can obscure how different decentralized models affect trial participants, data integrity, enrollment, and overall feasibility. In this article, we explore why the term “DCT” is often overly simplistic and why a more nuanced way of thinking about decentralized clinical trials is critical for conducting effective, patient-centric studies.
Challenges with the Current DCT Definition
Decentralized Clinical Trials encompass a spectrum of strategies to reduce or eliminate the need for participants to visit traditional clinical trial sites. These include telemedicine, mobile devices, smartphones, portable equipment, and mobile/local healthcare providers.
While the intent behind DCTs is commendable—improving patient access and reducing burdens—the broad application of the term has led to several issues:
- Overgeneralization: By grouping disparate methodologies, we risk overlooking each approach's unique challenges and benefits.
- Misinterpretation of Data: Studies and surveys that evaluate DCT effectiveness may base their conclusions on limited aspects of decentralization, such as the use of mobile devices. These may not represent other DCT modalities, which can tarnish the entire grouping of technologies.
- Undermining Specialized Solutions: Innovative services that don't fit neatly into the generalized DCT category may not receive appropriate recognition or consideration despite offering significant advantages.
Not All DCTs Are Created Equal
Consider the recent Tufts Center for the Study of Drug Development report, which included telemedicine, mobile devices, smartphones, portable equipment, and mobile/local healthcare providers, all under the DCT umbrella. Some of these delivery modalities can have significant patient challenges, such as:
- Dependence on participants' access to Wi-Fi.
- Issues with device compatibility and user proficiency.
- Concerns about battery life and device maintenance.
What can this equate to? A poor patient experience. Tufts found that the experience has been sub-optimal, with 69% reporting their DCT experience as ‘Fair’ or ‘Poor.’ Only 31% said their experience was ‘Good.’ These concerns are valid for trials that rely heavily on participant-managed mobile devices or wearables, they don't necessarily apply to other decentralized models. For instance, 20/20 Onsite has a 95+ patient NPS, indicating a disconnect between overall DCT generalizations and specialized patient-centric services.
The Need for a More Sophisticated Breakdown
To move the field of clinical research forward, it's crucial to move beyond generalizations and develop a more nuanced classification system for DCTs. Here's why:
1. Accurate Assessment of Efficacy
Grouping all decentralized approaches can skew perceptions of their effectiveness. For instance, challenges specific to wearable devices shouldn't affect the perceived value of point-of-need clinics or home nursing services, or vice versa.
2. Tailored Regulatory Guidelines
Regulators need clear distinctions to develop appropriate guidelines that address the unique aspects of each decentralized model, ensuring participant safety and data integrity.
3. Better Stakeholder Communication
Sponsors, CROs, and participants benefit from precise terminology that communicates what to expect from a trial. This clarity can enhance collaboration and improve overall trial outcomes.
Real-World Application: 20/20 Onsite
At 20/20 Onsite, we are the only provider dedicated to patient-centric, point-of-need ophthalmic assessments for clinical trials. We bring the assessment directly to participants' doorsteps. Our approach addresses many of the challenges highlighted in studies focused on mobile device-dependent DCTs:
- Controlled Environment: Our Mobile Vision Clinic is equipped with advanced ophthalmic equipment operated by trained professionals, ensuring high-quality data collection without relying on participants to manage devices.
- Reduced Participant Burden: By eliminating the need for participants to travel to clinical sites, we improve recruitment and retention rates, especially among populations that might otherwise face barriers to participation.
- Data Integrity: Professional oversight and standardized procedures enhance the reliability and consistency of the data collected. It's quality ocular endpoint protection.
Despite these distinctions, our services are often lumped under the DCT label, leading to misunderstandings about our capabilities and the value we bring to clinical trials.
Proposed Framework for Decentralized Trial Methodologies
To support clearer evaluation and alignment with FDA guidance when conducting a decentralized clinical trial, we propose categorizing trial components into distinct segments:
- Remote Digital Monitoring
- Examples: Wearables, smartphone apps, and telehealth platforms.
- Characteristics: Participant-managed devices, reliant on technology proficiency and personal internet access.
- Professional In-Home Services
- Examples: Home nursing visits and phlebotomy services.
- Characteristics: Healthcare professionals conduct study procedures in participants' homes.
- Point-of-Need Clinics
- Examples: Specialized vehicles equipped as mobile clinics (like 20/20 Onsite's Mobile Vision Clinic).
- Characteristics: Controlled clinical environments were brought to participants, operated by professionals, and offered services comparable to traditional sites.
- Hybrid Models
- Examples: Combination of site visits with remote monitoring or home services.
- Characteristics: Flexibility to accommodate participant needs while maintaining certain centralized components.
By adopting this framework, the industry can more clearly evaluate benefits and challenges across trial-related activities, enabling more consistent, compliant, and optimized trial designs.
Rethinking Decentralized Clinical Trials for What Comes Next
The term Decentralized Clinical Trials has accelerated innovation and advanced more patient-centric approaches to conducting clinical research. As DCTs evolve, it’s increasingly important to move beyond a one-size-fits-all label and recognize how different decentralized models—from in-person and remote trial elements to direct-to-patient assessments—support endpoint quality, data integrity, and participant experience.
By acknowledging the unique strengths of each decentralized methodology, sponsors can design clinical studies that better manage variability, support informed consent and follow-up, and generate reliable safety profiles. This clarity ultimately leads to stronger endpoints, improved patient experiences, and more effective clinical trials.
To learn more about how 20/20 Onsite delivers quality ocular endpoint protection through our Mobile Vision Clinics, book a call to discuss your trial.
References:
1. Tufts CSDD 2020 Protocol Performance Study