Rethinking Decentralized Clinical Trials: Why One Size Doesn't Fit All

Clinical trials are evolving rapidly. Driven by technological advancements, there is a pressing need to make studies more patient-centric. 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 to some extent, the umbrella term "DCT" is too broad, lumping together various methodologies and technologies under one label.

Being on the frontlines, we've observed firsthand how this generalization can obscure specialized services' unique value and capabilities. Let’s explore why the term "DCT" may be overly simplistic and urge for a more nuanced terminology that reflects the varied approaches transforming clinical research today.

The Challenge 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:

1. Overgeneralization: By grouping disparate methodologies, we risk overlooking each approach's unique challenges and benefits.
2. 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. 
3. 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.

Example: 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 facilitate a more detailed understanding, we suggest categorizing decentralized clinical trial components into distinct segments:

1. Remote Digital Monitoring
   • Examples: Wearables, smartphone apps, and telehealth platforms.
   • Characteristics: Participant-managed devices, reliant on technology proficiency and personal internet access.
2. Professional In-Home Services
   • Examples: Home nursing visits and phlebotomy services.
   • Characteristics: Healthcare professionals conduct study procedures in participants' homes.
3. 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.
4. 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 such a framework, the industry can more accurately assess the benefits and challenges associated with each, leading to optimized trial designs.

Conclusion

The term "Decentralized Clinical Trials" has driven innovation and pushed the industry towards more patient-centric approaches. It’s also highly effective at making clinical trials more successful. However, refining our terminology and classifications to reflect the diversity within DCTs is timely as we continue to evolve.

Recognizing the unique contributions of different decentralized methodologies will lead to more effective trials, improved patient experiences, and, ultimately, better healthcare outcomes. Let's embrace the complexity that drives true innovation in clinical trials.

To learn more about how 20/20 Onsite offers quality ocular endpoint protection with our Mobile Vision Clinic, book a call to discuss your trial.

References:
1. Tufts CSDD 2020 Protocol Performance Study