The U.S. Food and Drug Administration (FDA) issued final guidance titled “Conducting Clinical Trials with Decentralized Elements.” This guidance provides recommendations for sponsors, investigators, and other stakeholders on implementing decentralized elements in clinical trials.
A decentralized clinical trial (DCT) is defined as a trial where trial-related activities occur outside traditional clinical trial sites, such as:
- Telehealth visits
- In-home visits by remote trial personnel
- Visits with local healthcare providers
DCTs that permit tests to be performed independently by participants at home (e.g., spirometry) may introduce variability compared to tests performed under supervision at traditional clinical trial sites. Training or video supervision (i.e., during a telehealth visit) may reduce such variability.
Likewise, allowing participants to choose whether an assessment will be performed at a traditional clinical trial site or remotely may result in bias (e.g., sicker participants may prefer remote visits).
The protocol should specify which visits will be conducted at traditional clinical trial sites, which visits will be conducted remotely, and which visits can be left to participants’ choice. In general, obtaining patient input may be helpful in ensuring that the clinical trial design fits participants’ needs and that remote activities are feasible.
DCTs enable remote participation, which can:
- Increase convenience for trial participants
- Reduce the burden on caregivers
- Expand access to more diverse patient populations
- Improve trial efficiency
- Support research on rare diseases and those affecting individuals with limited mobility
The guidance is part of the FDA’s broader effort to modernize clinical trial design and conduct, improving efficiency and reducing burdens on participants and trial personnel.
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