Technologies

How to decentralize clinical trials in three steps

Published: 03.26.2024

 

Decentralized clinical trials (DCTs) offer numerous advantages. However, many organizations hesitate to integrate DCT solutions into their clinical research due to limited experience, lack of trust in new technology, or uncertainty about responsibilities. These three steps can facilitate the transition.

 

What is a decentralized clinical trial?

Traditionally, clinical trials are conducted at designated sites such as hospitals, research centers, or university clinics. Patients visit these sites for consultations, complete questionnaires, and undergo health assessments. In contrast, a decentralized clinical trial shifts the focus away from physical sites, allowing data collection and clinical research activities to occur remotely. This can be achieved through:

  • Remote monitoring and collection of vital signs via digital health devices, such as smartwatches that measure pulse or sleep trackers that assess sleep patterns

  • Televisits through video calls between study staff and participants

  • Digital transmission of clinical questionnaires, reducing the need for on-site interviews

  • A digital participant portal to facilitate communication between patients and study teams and streamline data collection

  • Social media groups and digital channels for patient support and engagement

This decentralized approach enhances patient-centricity by making clinical trial participation more accessible and aligned with patient needs.

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The advantages of decentralized clinical trials

Few clinical studies are fully decentralized. In many cases, hybrid approaches—where select digital elements are integrated into traditional clinical trials—offer substantial benefits:

  • Improved data collection in real time through wearable technology and other remote health monitoring tools

  • Expanded participant diversity, as patients are not restricted by geographic location

  • Increased patient engagement and reduced dropout rates due to more flexible, patient-friendly study designs

  • More efficient workflows with digital solutions, enhancing clinical trial management

  • Lower costs and shorter timelines for study execution, potentially accelerating market access for new medicines

 

Step 1: Stay up to date on regulations and technology

The clinical research landscape is evolving rapidly, driven by advancements in digital health technology. Organizations implementing decentralized clinical trials must stay informed about regulatory updates, technological innovations, and best practices. Important considerations include:

  • How can digital technologies and services improve clinical research?

  • What do current regulations permit in decentralized trial designs?

  • Are there opportunities for collaboration with technology providers to enhance DCT implementation?

Maintaining a resource list with insights from project managers, research staff, and external partners can help teams navigate DCT adoption effectively.

 

Step 2: Address the needs of all stakeholders

As digital solutions become more prevalent in medicine and clinical trials, the expectations of study participants and investigators are changing. Patients are more informed and proactive about clinical trial participation, while research teams must adapt to new technologies and workflows. Key questions to consider:

  • How much time will participants need to dedicate to the trial?

  • Are there sufficient remote communication channels for patient support and feedback?

  • Which existing processes will be replaced by new digital methods?

  • How much effort is required for clinical trial sites to implement decentralized processes?

 

Step 3: Build trust in new methods

Replacing established clinical trial workflows with decentralized approaches requires confidence from all stakeholders. Successful implementation depends on education, clear communication, and support. Strategies to build trust include:

  • Training clinical teams and participants in the use of digital technologies and remote health monitoring tools

  • Clearly defining roles and responsibilities to avoid confusion

  • Providing continuous support, addressing concerns, and integrating feedback into trial processes

 

Interoperability: A key challenge in decentralized clinical trials

One final consideration: Implementing digital solutions across multiple trial sites and study participants generates large volumes of clinical data in different formats. To ensure seamless data collection and interpretation, interoperability is crucial.

A centralized clinical data management system can standardize information from various sources, allowing real-time data reconciliation and analysis. This enhances transparency, improves study efficiency, and ultimately supports the success of decentralized clinical trials.

 

Conclusion: Decentralized clinical trials as the future of research

The implementation of a DCT requires a targeted strategy to overcome regulatory, technological and organizational challenges. Through a structured approach, all stakeholders benefit from more flexible, efficient and patient-friendly clinical research.

Digital technologies enable the modern conduct of clinical trials, which increases the quality of the data collected and optimizes the research process. Companies that rely on the DCT approach secure an innovative edge in clinical research.