Decentralized Clinical Trials for Drugs, Biological Products, and Devices Guidance Free download PDF

This draft guidance provides recommendations for sponsors, investigators, and other  stakeholders regarding the implementation of decentralized clinical trials (DCTs) for drugs,  biological products, and devices. In this guidance, a DCT refers to a clinical trial where some  or all of the trial-related activities occur at locations other than traditional clinical trial sites.  In fully decentralized clinical trials, all activities take place at locations other than traditional trial  sites. These trial-related activities may take place at the homes of trial participants or in local  health care facilities that are convenient for trial participants. In hybrid DCTs, some trial  activities involve in-person visits by trial participants to traditional clinical trial sites, and other  activities are conducted at locations other than traditional clinical trial sites, such as participants’  homes.

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Many clinical trials already include decentralized elements such that not all trial-related activities  involving participants take place at traditional clinical trial sites. For example, laboratory tests  are often conducted by clinical laboratory facilities at locations remote from traditional trial  sites. DCTs have the potential to expand access to more diverse patient populations and improve  trial efficiencies. Advances in clinical care using electronic communications and information  technology to interact with trial participants in different locations (i.e., telehealth) allow for  fewer in-person visits to clinical trial sites. Digital health technologies (DHTs), for example,  have expanded the types of trial-related data that can be obtained remotely from trial  participants. By enabling remote participation, DCTs may enhance convenience for trial  participants, reduce the burden on caregivers, and facilitate research on rare diseases and  diseases affecting populations with limited mobility or access to traditional trial sites. This may  help improve trial participant engagement, recruitment, enrollment, and retention of a  meaningfully diverse clinical population.

 

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Manostaxx
Manostaxx – Industrial Management Consulting

See:  https://manoxblog.com/2024/03/19/pharmas-next-strange-trip-the-industry-alters-its-state-of-mind-on-psychedelics-2/

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