FDA's new guidance regarding Decentralized Clinical Trials (DCTs)

The FDA has recently released a new guidance on Decentralized Clinical Trials (DCTs), signaling a significant step forward in the evolution of clinical research methodologies. This guidance comes as part of the FDA's ongoing effort to clarify and advance the use of DCTs, which employ elements where some or all trial activities occur away from traditional clinical trial sites. This shift towards decentralization has been further supported by innovative platforms like OnTracka, which exemplifies how technology can enhance the efficiency and accessibility of clinical trials by facilitating remote and decentralized operations.

• Draft Guidance: In 2023, the FDA released a draft guidance aimed at providing recommendations for sponsors, investigators, and other stakeholders on implementing DCTs for drugs, biological products, and devices. This guidance was part of fulfilling requirements set by the Food and Drug Omnibus Reform Act (FDORA).

  
  

• Key Points from the Draft and Subsequent Developments:

  • Role of Healthcare Providers (HCPs): The guidance clarified that in-person visits and trial-related activities could be conducted by HCPs not directly part of the trial, provided these activities are within the HCP's usual scope of practice and don't require deep protocol knowledge.

  • Use of Technology: There's an emphasis on the use of telehealth, digital health technologies for data collection, and other remote monitoring tools.

  • Investigational Product Handling: Recommendations included specific protocols for packaging, shipping, and storage of investigational products, ensuring proper handling even when products are sent directly to participants.

    
    

• Final Guidance: By September 2024, the FDA issued final guidance titled “Conducting Clinical Trials with Decentralized Elements.” This step was part of modernizing trial designs to enhance efficiency and reduce participant burden. It covered various aspects like the use of local labs, imaging, procedures by local HCPs, telehealth, and ensuring data management integrity in decentralized settings.

  
  

• Public Sentiment and Industry Response: From posts on X, there's an evident acknowledgment and discussion around this guidance. The industry seems to welcome the clarity on how decentralized elements can be integrated without compromising trial integrity, focusing on aspects like local healthcare provider involvement, remote consent processes, and the management of investigational products.

  
  
  
  

The FDA's guidance on DCTs represents a significant step towards adapting clinical trial methodologies to contemporary technology and patient expectations, aiming for more accessible, efficient, and participant-friendly research processes. This move reflects a broader trend towards leveraging technology in healthcare to make clinical research more inclusive and less burdensome.