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.
Guidance: Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice
The USFDA's draft guidance on "Integrating Randomized Controlled Trials (RCTs) for Drug and Biological Products into Routine Clinical Practice" outlines a framework for how RCTs can be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.
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