top of page

SFDA Guidance: Conducting Clinical Trials with Decentralized Elements & Integrating Randomized Controlled Trials

Writer's picture: Sharan MuruganSharan Murugan

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health & Oncology Center of Excellence released final guidance "Conducting Clinical Trials With Decentralized Elements" that provides recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralized elements in clinical trials.


Decentralized Clinical Trial (DCT): A clinical trial that includes decentralized elements where trial-related activities occur at locations other than traditional clinical trial sites. Decentralized elements allow trial-related activities to take place remotely at locations convenient for trial participants. Decentralized elements include, among other things, telehealth visits with trial personnel, in-home visits with remote trial personnel, or visits with local healthcare providers, among others.


The guidance outlines how sponsors, investigators, and other stakeholders should plan, implement, and monitor decentralized elements of clinical trials. These elements include remote visits, use of digital health technologies, and decentralized trial oversight, with the goal of promoting efficiency, participant engagement, and data quality.


For further details, refer to the full guidance document provided by the USFDA here.


The USFDA's draft guidance on "Integrating Randomized Controlled Trials (RCTs) for Drug and Biological Products into Routine Clinical Practice" outlines a framework for how RCTs can be designed and implemented within real-world healthcare settings. This approach can enhance clinical trial efficiency and increase relevance to routine care, helping to streamline the process of bringing new drugs and biological products to market.


Incorporating clinical trials into routine practice is a growing trend as it can improve trial efficiency and generalizability. Traditionally, RCTs take place in specialized settings, which may not always represent the broader patient population or typical healthcare practices. This guidance advocates for a shift toward embedding RCTs in everyday clinical workflows to address these limitations.


The FDA will continue to oversee trials conducted within routine clinical settings, with the potential for inspections to ensure compliance with regulatory standards. Trials should be designed to withstand such scrutiny while minimizing the disruption to routine healthcare activities.


For further details, refer to the complete guidance document provided by the USFDA here.

Comments


I Sometimes Send Newsletters

Thanks for submitting!

  • LinkedIn
  • Facebook
  • Twitter
  • Instagram

DISCLAIMER

The views expressed in this publication do not necessarily reflect the views of any guidance of government, health authority, it's purely my understanding. This Blog/Web Site is made available by a regulatory professional, is for educational purposes only as well as to give you general information and a general understanding of the pharmaceutical regulations, and not to provide specific regulatory advice. By using this blog site you understand that there is no client relationship between you and the Blog/Web Site publisher. The Blog/Web Site should not be used as a substitute for competent pharma regulatory advice and you should discuss from an authenticated regulatory professional in your state.  We have made every reasonable effort to present accurate information on our website; however, we are not responsible for any of the results you experience while visiting our website and request to use official websites.

bottom of page