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USFDA Guidance: Decentralized Clinical Trials for Drugs, Biological Products, and Devices

Today (02 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health

Oncology and Center of Excellence jointly released a draft guidance on "Decentralized Clinical Trials for Drugs, Biological Products, and Devices".

A Decentralized Clinical Trial (DCT) is defined as a clinical trial where some or all of the trial-related activities occur at locations other than traditional clinical trial sites.

As part of this draft guidance, sponsors, investigators, and other stakeholders are provided with recommendations regarding how to implement decentralized clinical trials (DCTs) for drugs, biological products, and devices.

Trial-related activities may take place in participant's homes or at a nearby healthcare facility that is convenient for trial participants. Hybrid DCTs include in-person trials at traditional clinical trial sites for some trial activities, while other trials are conducted at locations other than traditional clinical trial sites, such as participant's homes.

Through DCTs, patients from diverse populations can be reached and trial efficiencies can be improved. By utilizing electronic communications and information technology, clinical trial participants may be able to interact with each other in different locations (i.e., telehealth), resulting in fewer in-person visits to clinical trial sites.

Generally, DCTs include specific plans to facilitate decentralization of the trial. These plans should include, as appropriate, the use of local health care facilities, local health care providers, and local clinical laboratory facilities; visits to trial participants' homes; and distribution of IP directly to trial participants.

A fully decentralized trial may be appropriate for investigational products (IPs) with well-characterized safety profiles and no complex medical assessments.

To know in detail about the DCT Design, Software Used in Conducting DCTs etc, click this LINK.


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