Table 1.

Terminology for types of master protocols

Type of trial	Objective	Examples of potential innovative approaches
Umbrella	To study multiple targeted therapies in the context of a single disease	Within a conventionally defined disease (eg, diabetic kidney disease [DKD]), various biomarker‐based subgroups are defined and different drugs are tested in these subgroups. This approach supports individualizing treatments and personalized medicine.
Basket	To study a single‐targeted therapy in the context of multiple disease or disease subtypes	Many of the potential drug targets in DKD may also be useful for other etiologies of chronic kidney disease (CKD) such as IgA nephropathy or focal segmental Glomerulo sclerosis. A basket trial enrolls patients across various CKD etiologies and characterizes the drug effect in multiple disorders. This may enhance innovation while allowing sponsors a wider range of potential indications for a given molecule.
Platform	To study multiple‐targeted therapies in the context of a single disease in a perpetual manner, with therapies allowed to enter or leave the platform on the basis of a decision algorithm	Platform trials may lower the hurdle to take a new drug forward into a proof of concept clinical trial because a new molecule could be plugged into an ongoing clinical trial quickly and at a lower cost. An additional benefit is that the platform enables characterizing the efficacy and safety of novel drug combinations, potentially across conditions, mechanisms and sponsors, that would otherwise not be feasible in one trial. Finally, within the platform drugs can be targeted to subgroups based on biomarker profiles to personalize treatment.

Modified from Reference 22.