The US Food and Drug Administration (FDA) this week published a draft guidance on the use of master protocols in clinical trials of drugs and biologics research that replaces a pandemic-era guidance on the topic.
On 21 December, FDA published a draft guidance replacing its 2021 master protocol guidance, which was issued during the COVID-19 public health emergency (PHE) to facilitate the use of master protocol designs in certain studies to make them more efficient.
A master protocol study design allows the use of several substudies that may have different objectives, and in which researchers simultaneously evaluate multiple products or diseases and conditions. Following the expiration of the PHE declaration, FDA revised the 2021 guidance to enable it to remain in effect until it could issue the new draft guidance on the topic…
