Decentralized Clinical Trials (DCTs) are not a novel concept but have gained prominence with advancements in digital technology and the increasing need for patient-centric approaches. The recent release of the FDA’s final guidance on DCTs in September 2024 marks a significant milestone in this journey, providing much-needed clarity and support for sponsors looking to incorporate decentralized elements into their studies.

This guidance not only underscores the FDA’s commitment to modernizing clinical research but also highlights the potential of DCTs to expand trial access, improve diversity, and reduce burdens for participants—all while maintaining the rigor of traditional clinical trials. This blog explores the benefits of decentralized trials, highlights key attributes of the new guidance, and outlines strategies for implementing DCTs.

Overcoming challenges of brick-and-mortar trials

As clinical research evolves, the limitations of traditional brick-and-mortar clinical trials have become increasingly apparent. These challenges can create barriers for both patients and sponsors, including:

Accessibility issues: Patients often need to travel long distances to centralized trial sites, creating a burden for those in rural or underserved areas.

Enrollment and diversity challenges: Logistical challenges reduce participation rates and limit the diversity of study populations, affecting the generalizability of results.

High costs and rigid scheduling: Fixed site visits can create barriers for patients with demanding schedules, while sponsors face significant costs for maintaining trial sites and managing logistics.

DCTs offer a promising alternative, bringing greater flexibility and accessibility to the process. By leveraging technology and community-based approaches, DCTs are transforming how trials are conducted, offering:

Greater access: Telehealth visits, remote monitoring, and local provider partnerships reduce the need for travel and make trials more convenient.

Enhanced diversity and retention: Flexible trial models attract patients from underrepresented populations and improve retention by minimizing logistical burdens.

Cost and time efficiencies: DCTs can streamline operations to maintain or even improve study timelines.

Even if there’s only one of four visits that can be done at home, that’s still appreciated.

Driving clarity with guidance

The FDA’s regulatory guidance for DCTs provides essential clarity for sponsors and researchers, ensuring trials maintain rigor and compliance even when conducted outside traditional settings. This guidance addresses key challenges, such as data variability and the integration of local healthcare providers, while accommodating various operational models, from fully decentralized to hybrid trials. By setting clear standards, it ensures all models uphold data integrity and meet regulatory requirements.

The regulations are the regulations, whether your operational model is in a decentralized model or not.

Key topics of the guidance include obtaining informed consent remotely, verifying participant identity, ensuring proper training for personnel conducting assessments, and addressing logistical challenges, such as the shipment of investigational products to participants’ homes. Additionally, the guidance clarifies the responsibilities of sponsors, investigators, and Contract Research Organizations (CROs) in DCT operations while highlighting strategies to enhance trial access, diversity, and retention.

The role of local healthcare providers

A critical focus of the guidance is the role of local healthcare providers not directly affiliated with the trial. By incorporating these familiar professionals into the trial process, sponsors can reduce the burden on patients, enhance their comfort, and improve engagement. This approach not only helps to streamline trial operations but also fosters stronger patient retention and diversity by making trials more accessible to those in rural or underserved areas. Additionally, empowering trained caregivers or local providers to conduct specific assessments ensures consistency in data collection, even in decentralized settings.

Considerations for implementing DCTs

While DCTs mitigate many obstacles of traditional trials, they introduce their own complexities and require careful planning and execution to ensure success. The following tips are essential for operationalizing a DCT more effectively.

Leverage the reach of digital advertising

Using social media platforms like Facebook and Instagram for advertisements can help DCTs reach a diverse range of demographics. To achieve a varied participant base, sponsors should tailor their advertising to different groups, incorporating culturally sensitive messaging that resonates with various cultural backgrounds, ensuring broad demographic reach across age ranges and ethnicities, and collaborating with Institutional Review Boards (IRBs) to ensure that all communications are appropriate and effective.

Engage with regulators early

When considering DCTs, early engagement with regulatory bodies is vital. The operational models of DCTs differ significantly from traditional trials, necessitating detailed planning and consultation. Engaging with experts and regulatory bodies early in the process can help navigate the complexities and ensure compliance with all necessary guidelines.

Choose the right technology platforms

Technology is the backbone of decentralized trials. To facilitate remote monitoring, telehealth visits, and data collection, a robust, user-friendly platform is critical. Sponsors should look for solutions that support real-time data capture, secure communication, and easy participant access, while complying with regulatory standards like HIPAA and GxP to ensure data privacy and security.

Design flexible, patient-centered protocols

One of the key advantages of DCTs is flexibility. Trial protocols should be tailored to meet the needs of patients, whether through flexible scheduling for telehealth visits or remote monitoring options. Reducing the need for travel and providing personalized support will improve enrollment, retention, and overall patient satisfaction.

Support patients every step of the way

Dedicated help desks or hotlines play a crucial role in ensuring participants feel supported and informed throughout a decentralized clinical trial. These teams provide ongoing communication, addressing any concerns participants may have and fostering a sense of connection during the trial process. By offering consistent support, participants have a reliable point of contact to assist with any issues or questions, enhancing their overall experience. Additionally, this personalized approach helps build rapport, making participants feel valued and informed. Not only does this strategy improve patient retention, but it also ensures that data collection remains comprehensive and uninterrupted.

Our Patient Engagement and Retention Team is our call center… they form those relationships from the minute a person responds to an ad.

Long-term follow-up studies: A prime use-case for DCTs

Long-term follow-up is a critical component of many clinical studies, especially those involving treatments like cell and gene therapy. These studies require monitoring over extended periods, sometimes spanning several decades, to assess the long-term efficacy and safety of treatments.

DCTs offer a viable solution for managing these long-term follow-ups. By utilizing decentralized approaches, such as patient call centers, researchers can maintain ongoing communication with patients without overwhelming brick-and-mortar sites. These centers facilitate regular check-ins, ensuring that any adverse events or changes in health status are promptly reported and managed.

This approach not only alleviates the logistical burden on research sites but also supports patient retention by maintaining engagement and ensuring they feel connected to the study.

Reshaping clinical trial conduct

DCTs represent a significant advancement in clinical research methodologies. By broadening patient demographics, enhancing trial diversity, and simplifying long-term follow-up, DCTs offer a more inclusive and efficient approach to clinical research. As regulatory guidelines continue to evolve, the integration of DCTs into mainstream research is likely to expand, offering new opportunities for innovation and improvement in the field.

For support with implementing your DCT, contact us.

ABOUT PREMIER RESEARCH:

Premier Research, a global clinical research, product development, and consulting company, is dedicated to helping innovators transform life-changing ideas and breakthrough science into new medical treatments. We offer strategic solutions across the entire development lifecycle, from pre-clinical through commercialization, specializing in smart study design and full-service clinical trial management.   

Leveraging technology and therapeutic expertise, we deliver clean, conclusive data with a focus on reducing development timelines, securing access to the right patients, and effectively navigating global regulations to ensure submission-ready results.   

As an organization that puts patients first, we pride ourselves on helping customers answer the unmet needs of patients across a broad range of medical conditions. Visit premier-research.com. 