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How Curebase aligns with FDA guidelines for trial implementation

June 8, 2023

Last month, May 2023, the FDA put forth additional guidance to “provide recommendations for sponsors, investigators, and other stakeholders regarding the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and devices.” Decentralized trials, in the context of this FDA guidance, refer to any clinical trial where one or multiple study components take place at a location other than that of a traditional study research site. 

Although the “FDA’s regulatory requirements for investigations of medical products are the same for DCTs and traditional site-based clinical trials,” executing a decentralized trial can be very different from a traditional one. The FDA notes specific challenges related to DCTs including the difficulty of coordinating trial activities, sites, and participants across multiple locations, developing proper plans to successfully facilitate these trials, designing a DCT that is feasible, and ensuring appropriate training and oversight. 

Whether sponsors are experienced in the DCT space or not, the implementation of decentralized components within their studies doesn’t have to be difficult. Some DCT models can seem rigid with decentralized features that can only integrate into very specific study scenarios. In those circumstances, it can be difficult to ensure sponsors are finding study models that meet their needs and goals. Curebase is committed to delivering clinical trials to any patient anywhere and in doing so offers built-for-purpose, flexible decentralized trial solutions that not only align with FDA implementation guidance but also guide sponsors through the process. 

In this guidance document, the FDA touches on important topics within DCTs such as study design, remote clinical trial visits and clinical trial-related activities, digital health technologies and software used in conducting DCTs, roles and responsibilities, informed consent and institutional review board oversight, safety monitoring plans, and packaging and shipping of investigational products. These considerations may seem substantial, however, the best way to navigate the DCT space as a sponsor is to have a DCT partner that is well-informed and experienced in running a wide variety of DCTs. 

Curebase understands that every trial is different and knows how to seamlessly implement DCT components where applicable to mitigate unnecessary travel and in-person visits to lessen patient burden, boost retention, and save time, resources, and costs. 

Sponsors interested in implementing DCT components in their next study or even in an ongoing study should engage in conversations with Curebase as early as possible to address all of their study’s needs. This can ensure that anticipated roadblocks can be accounted for so sponsors are able to meet their goals without compromising on patient experience or efficiency.  

To learn more take a look at Curebase’s guide to selecting the right DCT vendor for your study.

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