5 Key Takeaways from Recent FDA Draft Guidance on Decentralized Clinical Trials (DCTs)

Decentralized Clinical Trials (DCTs) have changed the way clinical research is conducted, transforming traditional approaches and introducing innovative methodologies. In response to this shift, the FDA recently released draft guidance that provides valuable insights and recommendations for stakeholders navigating this evolving landscape. Key takeaways highlight critical considerations and best practices for implementing DCTs successfully. 

Design for Success: Integrate DCT elements from the start

One of the primary challenges in implementing DCTs is attempting to fit decentralized technologies into a protocol originally designed without their consideration. FDA guidance emphasizes the importance of designing protocols with DCT elements from the outset. Sponsors and investigators need to evaluate whether the study design lends itself to a fully decentralized approach, and if not, consider a hybrid model. Clinical ink experts are available to consult on the protocol design, providing guidance on which DCT technologies might best support study objectives and enhance the patient experience.

Accessible Trials for All: Provide provisioned devices for inclusivity

Ensuring access to technology for all patient populations is crucial for the success of DCTs. FDA guidance suggests providing approximately 15% of the study population with provisioned devices as part of a BYOD solution. This approach addresses patients who lack access to smartphones and caters to those who may not feel comfortable using their own personal devices for clinical trial purposes. Robust user testing and comprehensive translation capabilities can further enhance diversity. Clinical ink recommends user testing to assess accessibility and usability for different patient populations. Our in-app translation tools make it easy to manage multiple translations, ensuring all patient populations can fully engage in the DCT experience.

Empower Sites for Patient Care: Define clear roles for sponsors and investigators

FDA guidance emphasizes the importance of defining distinct roles and responsibilities for sponsors and investigators. In addition, Investigators should have ready access to all patient records generated during the trial to enable informed decisions regarding patient care during the trial and after it has completed.

Meanwhile, sponsors should incentivize sites to meet regulatory requirements regarding patient records.

“Sponsors should assign a final site payment once all patient data has been downloaded to the site servers for ongoing review as needed if a concern arises regarding patient safety. This serves as a reinforcement for sites to prioritize this crucial step.”

Bill Barrasso, Chief Compliance Officer, Clinical ink

By clarifying the roles of each party, sponsors ensure their sites are empowered to provide optimal patient care. Clinical ink technology facilitates connectivity between sites and patients, reducing site burden while providing them the tools and services to meet regulatory requirements.

Prioritize Patient Safety: Implement proactive Adverse Event (AE) reporting

Patient safety remains the top priority in DCTs. The recent FDA guidance advises having a clear plan for AE reporting, including instructions for patients to directly contact site personnel or emergency medical staff if needed. Clinical ink recommends incorporating patient instructions in e-diaries to remind patients to promptly communicate any worsening conditions to their healthcare provider.

Ensure Regulatory Compliance: Meet 21 CFR Part 11 standards

Clinical Ink technology is compliant with 21 CFR Part 11, which is mandatory. Clinical ink employs robust security measures, manages training, and processes to ensure compliance at every stage of the study.

Clinical ink has extensive experience, supporting more than 75 global DCTs. Our technology, services, and clinical expertise align with the regulatory guidance, providing our clients with the tools and support to conduct successful DCTs. It is important to remember that while technology can help facilitate the operational aspects of DCTs, it is the human element, prioritizing patient safety while adhering to regulatory guidelines, that remains key in achieving successful DCT outcomes.

For more information on solutions for DCTs, download our whitepaper, “A Prerequisite for More Flexible Clinical Trial Designs: an Integrated eSource Solution.”

Scroll to Top

Contact Clinical ink

Request more information, submit questions, set up a demonstration, and more.