DCT: 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 (DCT)?

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 new technology:

• 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: Keeping an eye on DCT regulations and technologies

The digital transformation opens up new opportunities in clinical research - but also presents study managers with complex decisions. Anyone planning a decentralized study should continuously monitor current regulatory frameworks and technological developments.

This is because both legal requirements and new tools can have a significant influence on whether a DCT approach is practicable and permissible. A structured overview is worthwhile here:

• Which technologies - such as eConsent, ePRO/eCOA, televisits or wearables - are scientifically validated and recognized by regulatory authorities?

• What requirements do authorities such as the EMA or FDA place on data security, transparency and patient consent in digital processes?

• Which digital services can specifically improve existing processes - e.g. through automation, better data availability or reduced susceptibility to errors?

A list of current innovations can help project managers to develop new strategies for their DCT.

Step 2: Consider the needs of all stakeholders

Successful DCTs requires the perspectives of all stakeholders to be taken into account. After all, digital processes not only change the day-to-day running of a trial, but also the roles and expectations of everyone involved - from patients and trial sites to the trial team.

Early dialog creates clarity and trust:

• For patients: How convenient is it to participate in the study from home? Are there any technical hurdles or concerns regarding data protection and data transfer?

• For study sites and investigators: How will workflows change? What training and support will be required?

• For sponsor teams: Which processes can be digitized without jeopardizing quality and regulatory requirements?

Needs-based planning that focuses on transparency, training and support strengthens acceptance of the digital study environment and enables a smooth process.

Step 3: Create trust in digital processes of DCTs

Digital technologies only work if everyone involved trusts them. Study managers therefore have a duty to address uncertainties at an early stage and counteract them in a targeted manner.
This includes

• User-centered training for patients, study personnel and investigators that conveys concrete application scenarios and reduces fear of contact.

• Transparent communication on data protection, data use and responsibilities - for example through comprehensibly prepared information materials or FAQs.

• Feedback mechanisms to systematically record and analyze feedback and incorporate it into the further development of digital processes.

This creates a trusting study environment in which everyone involved can work safely with digital tools and make the best possible use of their potential.

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.