pharmaphorum May 3, 2023
The FDA has issued draft guidance on the use of decentralised clinical trials (DCTs), which are increasingly being used by the pharma industry to tackle issues, such as diversity and inclusivity, in clinical research.
The new guidance – required by the passage of the FDA Omnibus Reform Act (FDORA) last year – provides recommendations for trial sponsors, investigators and others involved in clinical trials on how to carry out activities at locations other than traditional investigation sites.
That could include obtaining laboratory tests at a local facility rather than a research-active medical centre or conducting a clinical follow-up visit in the trial participant’s home using telemedicine, said the regulator in a statement.
The move comes a few months after the...
Today's Sponsors
Today's Sponsor