What are Decentralized Clinical Trials?

Decentralized clinical trials (DCTs) are popular in medical research. They provide a more flexible and patient-centric alternative to traditional site-based trials. By utilizing technology and innovative processes, DCTs allow participants to participate in clinical trials remotely, minimizing the need to be physically present at research sites. 

Key Takeaways

• Decentralized clinical trials (DCTs) use technology and innovative processes to allow participation beyond traditional research sites. 
• DCTs commonly include telemedicine visits, home health visits, direct-to-patient drug shipments, and remote data collection via wearables and apps.
• DCTs enhance participant diversity and accessibility by reaching a wider geographic pool. 
• They also improve participant engagement and retention by reducing the need for travel, thus increasing trial efficiency and data quality through real-time data access and frequent data collection.   
• Implementing DCTs poses regulatory compliance, technological integration, and data management challenges.

Decentralized Clinical Trials: Definition

Decentralized clinical trials use technology and innovative processes to offer participation options beyond physical presence at research sites. DCTs can range from traditional trials with minimal remote elements to hybrid trials combining decentralized, virtual, or remote components to fully virtual or entirely remote trials.

In a DCT, some or all activities occur at locations other than the traditional research site (e.g., the participant's home, a local healthcare facility, or a nearby laboratory). This flexible approach enables enrollment of individuals who live far away and allows researchers to collect larger volumes and data types at various time points.

DCTs often combine traditional and decentralized trial designs, incorporating elements like trial matching, telemedicine, wearable devices, home visits, patient-driven virtual interfaces, and direct-to-home delivery of study materials. 

They can expand access to a geographically diverse pool of participants, enhance recruitment and retention, reduce participant burden, and improve data collection and security.

However, DCTs also pose challenges, such as the complexity and risk in clinical trial management, the need for technological advances and reliable cybersecurity systems, and regulatory and operational obstacles that must be addressed.

Examples of DCT components

Some common components of decentralized clinical trials include:

Telemedicine Visits

Telemedicine enables clinical research staff to visit with trial participants remotely through cell phones, computers, tablets, and other devices. Virtual visits between patients and physicians help keep patients engaged and improve adherence to the study schedule and dosing.

Home Health Visits

Patients enrolled in digital clinical trials can access home delivery of all study supplies, such as the investigational drug, relevant devices, and lab kits. Home-health nursing visits can be arranged if a trial requires blood pressure readings, blood draws, or other data collection that depends on professional assistance or expertise.

Direct-To-Patient Drug Shipments

In DCTs, investigational products and study supplies can be shipped directly to patients' homes. This requires assurance of drug stability, appropriate storage facilities in the patient's home, and measures to prevent unauthorized access. 

It also requires methods to detect tampering, temperature tracking to ensure appropriate drug storage, dosing diaries to record drug administration, and communication between the storage system and the drug source to provide timely refills and prevent study interruptions.

Remote Data Collection Via Wearables and Apps

Through wearables, apps, and other technologies, data collection can be frequent, continuous, time-stamped, and accurate in DCTs. The primary benefit is that the data is captured for clinical interpretation in real-time, allowing the study team to access actionable data to make key decisions quicker than traditional data collection.

Benefits of Decentralized Clinical Trials

Decentralized clinical trials offer several advantages over traditional site-based trials, making them an increasingly attractive option for researchers, sponsors, and participants.

One key benefit is participant diversity and accessibility. DCTs can reach a wider, more geographically diverse pool of participants as they are not limited to recruiting from a specific physical location. 

This is particularly important for rare diseases or conditions that affect a small population spread out over a large area. Additionally, DCTs can improve accessibility for those with mobility or transportation difficulties, as they can participate from their homes.

Another advantage of DCTs is enhanced participant engagement and retention. By reducing the burden on trial participants, such as the need for frequent travel to a clinical site, DCTs can make participation more convenient and appealing. This convenience leads to better retention rates, as participants stay engaged throughout the study.

DCTs also improve trial efficiency and data quality. With digital tools and remote monitoring, data collection can be centralized and is more timely than traditional methods. 

This real-time data access allows researchers to make quicker decisions and adjustments as needed. Furthermore, the ability to collect data more frequently and in real-world settings can lead to a stronger evidence package and more robust findings.

Challenges of Implementing Decentralized Clinical Trials

While decentralized clinical trials offer numerous benefits, implementing them can present some challenges.

From a regulatory perspective, ensuring compliance with regulations like 21 CFR Part 11 for electronic records and signatures and data privacy laws like GDPR requires careful planning and execution. Additionally, navigating varying geographic regulations can add complexity when conducting a global DCT.

Operationally, implementing a DCT often requires an initial investment in new technologies and processes. Robust data management planning is necessary to accommodate the data collected, non-traditional data collection methods, data transfer, and archival. 

Integration across all technology systems and stakeholders is also key to ensuring seamless communication and data flow.

To mitigate these challenges, many sponsors and sites implement a decentralized approach for study components, such as adopting an eConsent system, a virtual visit system, home health visits, or any combination of virtual trial components. This allows for a gradual transition and the ability to address challenges incrementally.

How Do Decentralized Clinical Trials Work?

DCTs leverage various virtual tools and technologies to enable remote participation and data collection. These tools include telemedicine for virtual visits between patients and physicians, sensory-based technologies, and wearable devices for continuous data collection. 

It could also entail home health visits for procedures requiring professional assistance, patient-driven virtual health care interfaces for engagement and adherence, and direct-to-home delivery of study drugs and materials.

The level of decentralization in a clinical trial can vary. In a fully decentralized trial, all activities from recruitment to treatment to data collection occur remotely, without in-person interactions between participants and the study team. 

However, many DCTs adopt a hybrid approach, incorporating a mix of virtual and in-person elements tailored to the study's specific needs.

For example, a hybrid trial may conduct recruitment, consent, and data collection remotely but still require participants to visit a local lab for certain tests or procedures. The balance between virtual and in-person components depends on factors like the therapeutic area, the study protocol's complexity, and the target population's needs.

When designing a DCT, carefully consider which elements can be effectively decentralized and which may require in-person interactions. Also, ensure that the virtual tools and technologies are reliable, secure, and user-friendly for participants. 

Partnering with experienced decentralized clinical trial providers like Atlantia Trials can help navigate these decisions and ensure a successful trial.

Regulatory Guidance on Decentralized Clinical Trials

As the adoption of decentralized clinical trials continues to grow, regulatory agencies have recognized the need for guidance to ensure their safety and effectiveness.

In response to the COVID-19 pandemic, the FDA issued guidance on conducting clinical trials remotely, providing flexibility and recommendations for sponsors and investigators to maintain trial integrity while prioritizing participant safety.

Building upon this, in May 2023, the FDA released a draft guidance that provides comprehensive recommendations for implementing DCTs to advance medical product development and research. This guidance covers various topics relevant to sponsors, investigators, and other stakeholders involved in DCT planning and execution.

The draft guidance delves into design considerations for DCTs, including selecting appropriate decentralized elements and developing contingency plans. It also addresses the conduct of remote clinical trial visits and activities, providing recommendations for maintaining participant safety and data integrity in a virtual setting.

The guidance significantly focuses on digital health technologies for remote data acquisition in DCTs. The FDA outlines considerations for selecting and validating these technologies and ensuring their secure and reliable use throughout the trial.

The guidance also clarifies the roles and responsibilities of sponsors and investigators in a DCT setting, emphasizing the importance of clear communication and oversight. Additionally, the FDA recommends obtaining informed consent and ensuring appropriate IRB oversight in DCTs.

As you navigate the evolving landscape of DCTs, familiarizing yourself with this regulatory guidance can help ensure your trial is designed and conducted following the FDA's expectations, ultimately supporting the development of safe and effective medical products.

Are Decentralized Clinical Trials the Future of Medical Product Development?

The COVID-19 pandemic accelerated the adoption of decentralized clinical trial elements, as stay-at-home orders and social distancing requirements made traditional site-based trials challenging to conduct. 

This shift coincided with advancements in digital health technologies, such as wearable devices, telemedicine platforms, and remote monitoring tools, enabling the broader implementation of DCTs.

DCTs offer several potential benefits that could shape the future of medical product development. They enhance participants' convenience by reducing the need for frequent site visits and allowing for remote participation. 

This increased flexibility can expand access to more diverse populations, including those in remote areas or with mobility limitations. DCTs also have the potential to improve trial efficiencies and reduce costs by streamlining trial processes and reducing the reliance on physical sites.

Moreover, DCTs can facilitate research on rare diseases and populations with limited mobility. They enable participation from a wider geographic area, which is particularly crucial for conditions with small and geographically dispersed patient populations.

Recognizing these benefits, the FDA expects DCTs to play an important role in addressing public health needs. The agency is committed to working with sponsors to discuss how decentralized elements may fit into their clinical trials.

Conclusion

Tailored hybrid trials are a compelling approach for clinical development programs. These trials combine the benefits of fully remote trials such as increased participant convenience and diversity, with the scientific rigor and oversight of traditional site-based studies. 

Hybrid trials can help you optimize your product development strategy for success in the evolving clinical research landscape by striking the right balance between virtual and in-person elements.

Offering flexibility and reduced costs while preserving data precision and integrity, hybrid trials address many challenges of both traditional site-based studies and fully remote models. Atlantia Clinical Trials can help you leverage these benefits through a tailored hybrid trial approach.

Discover how Atlantia's hybrid trial approach can revolutionize your clinical research. Contact us to optimize your next study's efficiency and reach.