The US Food and Drug Administration (FDA) has recently taken steps to promote the advancement of decentralized clinical trials (DCTs), recognizing the potential to improve patient access and participation. As the VP of Compliance at Datacubed Health, I would like to share our analysis of these developments and offer recommendations to sponsors, CROs, and sites on how to best implement DCTs in their clinical trial processes.
Key Points from FDA Guidance:
The FDA has released draft guidance for public consultation on the use of digital health technologies (DHTs) in DCTs, which can be found here.
Equally important, the accompanying press announcement highlights the FDA’s commitment to advancing DCTs, with a focus on increasing patient access, engagement, and quality of life, as well as reducing administrative burdens on sponsors and investigators. You can read the press announcement here.
Recommendations for Sponsors, CROs, and Sites:
Stay informed and engaged
Keep abreast of the latest FDA guidance and provide feedback during public consultation periods. As a result, this will ensure that you are well-prepared for the evolving regulatory landscape and can make informed decisions for your clinical trial designs.
Key points to consider:
- Regularly review FDA guidelines and industry best practices related to decentralized clinical trials and digital health technologies.
- Participate in industry forums, webinars, and conferences to stay current with the latest trends and developments in DCTs.
- Engage with regulatory authorities, offering feedback and seeking clarification on guidance documents to ensure compliance with evolving regulations.
Prioritize patient-centricity
Utilize DHTs and DCTs to enable a more patient-centered approach to clinical trials. Specifically, consider factors such as patient convenience, comfort, and accessibility when designing and implementing DCTs.
Key points to consider:
- Design DCTs to minimize the burden on patients by reducing travel, time commitments, and invasive procedures whenever possible.
- Develop patient engagement strategies, including educational materials and support resources, to help patients understand their role in the trial and promote adherence to study protocols.
- Solicit patient feedback to continuously improve trial design and execution, ensuring patients’ needs and preferences are considered.
Embrace technology
Invest in cutting-edge DHTs to improve data collection and patient engagement. Leverage platforms and tools that enable remote monitoring, eConsent, and secure data sharing. Be proactive in addressing potential technical and cybersecurity challenges.
Key points to consider:
- Research and invest in DHTs that facilitate remote data collection, such as wearable devices, mobile apps, and telehealth platforms. (Draft Guidance on DHTs can be found here)
- Implement Part 11-compliant electronic data capture (EDC) systems and electronic clinical outcome assessment (eCOA) tools to streamline data management and improve data quality.
- Establish secure data storage and sharing practices to safeguard patient privacy and comply with data protection regulations.
Collaborate with industry partners
Forge strategic partnerships with experienced DCT providers, technology vendors, and other stakeholders to maximize your organization’s DCT capabilities. As a result, collaborating will help ensure the successful design, execution, and management of decentralized trials.
Key points to consider:
- Form alliances with DCT vendors that offer expertise in technology, patient engagement, and regulatory compliance.
- Partner with academic institutions and patient advocacy groups to better understand the patient experience and ensure trial design addresses their needs.
- Join industry consortia and working groups focused on advancing DCT best practices and standardization.
Invest in staff training and education
Equip your team with the necessary skills and knowledge to effectively implement and manage DCTs. This includes understanding the regulatory landscape, digital health technologies, and best practices for patient engagement.
Key points to consider:
- Provide training programs for staff on DCT-related technologies, such as wearable devices, telemedicine, and data management tools.
- Offer regular workshops and seminars to educate staff on evolving regulatory requirements and industry trends.
- Develop a culture of continuous learning to ensure your team stays up to date with the latest DCT advancements.
Develop a robust risk management plan
Identify potential risks and challenges associated with DCTs, and establish mitigation strategies to address them. Specifically, data integrity, privacy, and security concerns, coupled with the management of remote data collection and monitoring.
Key points to consider:
- Conduct a thorough risk assessment, identifying potential challenges related to data quality, privacy, and security in DCTs.
- Establish protocols for monitoring and mitigating risks throughout the trial, including remote site monitoring and data integrity checks.
- Develop contingency plans for potential technology failures or disruptions, ensuring minimal impact on trial progress and patient safety.
Foster a culture of innovation
Encourage your organization to think outside the box and explore new, innovative ways to conduct clinical trials. This includes embracing DCTs as a means to improve patient access, engagement, and overall trial efficiency.
Key points to consider:
- Encourage open dialogue and idea-sharing within your organization, promoting creative solutions to challenges in clinical trial design and execution.
- Support pilot programs and proof-of-concept studies to test new DCT technologies and methodologies before scaling up.
- Recognize and reward innovative approaches that demonstrate a positive impact on patient engagement, trial efficiency, and data quality.
conclusion
All in all, as the FDA continues to promote the advancement of decentralized clinical trials, sponsors, CROs, and sites must adapt to these changes and seize the opportunities presented. By staying informed, embracing technology, and prioritizing patient-centricity, we can collectively transform the clinical trial landscape for the better. Given these points, let’s work together to advance clinical research and improve the lives of patients worldwide.