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FDA’s Decentralized Trial Guidance: Investigator, Health Care Provider Demarcation Raises Questions

 
• By Brenda Sandburg

The investigator's ability to delegate trial-related activities to local HCPs could create operational and reimbursement challenges, as well as potentially boost patient recruitment, stakeholders said. The guidance does not address digital divide and how to deal with a massive influx of data.

Clinical trial
FDA guidance on decentralized clinical trials focuses on the role of local healthcare providers. • Source: Shutterstock

The US Food and Drug Administration’s draft guidance on decentralized clinical trials describes when investigators can delegate trial-related activities to local health care providers. However, there are questions about how local HCPs will be incorporated into the studies.

FDA issued the draft guidance on decentralized clinical trials (DCTs) in May. The document provides recommendations for their implementation, including the roles and responsibilities of sponsors and investigators

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