pharmaphorum August 25, 2023
The COVID-19 pandemic pushed decentralised clinical trials (DCTs) into the mainstream. But when it comes to guidance and regulations about how those trials should be performed, they’ve mostly been governed by short-term pandemic documents, many of which are set to expire.
Enter ICH E6(R3), a new draft guidance document from the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. This new document, designed to be resilient to changing technologies, could bring the clarity researchers are looking for. But regulators need the industry’s feedback to make that happen.
In today’s podcast, Medable chief...
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