The FDA Regulations is adopting further measures to facilitate the use of decentralized clinical trials (DCTs), in which part or all trial-related activities take place at places other than conventional clinical trial sites, including medicines, biologics, and devices.
The government has issued draft guidance for sponsors, investigators, and other stakeholders on how to use DCTs to enhance medical product development and research. Suggestions include doing laboratory testing at a neighbourhood institution or using videoconferencing to make a clinical follow-up visit at the trial participant’s home.
DCTs will enable participants to take place in their homes or other convenient places for trial-related activities, expanding the breadth and variety of participants and improving accessibility for those with uncommon diseases or mobility issues. This strategy will make it easier to develop medications, especially in areas of unmet medical need, leading to a wider range of available treatments and better patient outcomes.
The agency’s 2020 suggestions to enable trial decentralization in response to the COVID-19 public health emergency and its accompanying disruptions, including quarantines, closures, and travel restrictions, were based on the draft advice. The FDA has long considered the benefits of decentralized clinical trials enabled by advances in digital health technologies and the COVID-19 pandemic. These trials can reduce the burden on caregivers, expand access to more diverse populations, improve research efficiency and facilitates research on rare diseases and disorders in populations with limited mobility.
The FDA has revised guidance on topics such as DCTs and traditional site-based clinical trials to better understand the FDA’s regulatory requirements for medical products.
- DCT Design Considerations
- Conducting clinical trial-related tasks and distant clinical trial visits in a DCT.
- Using digital health tools to gather data for a DCT online.
- Determination of suitability of research products for use in DCT
- Investigational product distribution and packing in a DCT
The FDA expects that clinical trials with decentralized components will be crucial to meeting the public’s requirements. In order to discuss how decentralized aspects could fit within a clinical study, the FDA is dedicated to collaborating with sponsors.
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Source: FDA.gov
