Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.1 - Platform, basket and umbrella trials

Document information
Reference	WHO WHO - Guidance for best practices for clinical trials 2024
Validity area	WHO
Scope(s)	G
Document name	WHO - Guidance for best practices for clinical trials
Version / Revision	2024
Status	Current
Document type	International guideline
Language(s)	EN
Description	WHO - Guidance for best practices for clinical trials
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 4 — Unit 4.4.0
Scope	G
Document part	1.1 - Platform, basket and umbrella trials
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Adaptive design, Protocol, Placebo, Study design

Content

[...] Platform, basket and umbrella trials all use master protocols (15–18) which allow simultaneous evaluation of multiple interventions within the same overall trial structure. Platform trials are designed to study multiple interventions among people with one or more closely related diseases (for example, cancers due to genomic subtypes) or health conditions (for example, pneumonia). They may use a common control group (for example, treatment A vs treatment B vs a common control) or, more efficiently, a factorial design that involves more than one randomized comparison (for example, treatment A vs placebo A and treatment B vs placebo B) such that some participants may get more than one active treatment while a minority receives a placebo. They are efficient and flexible, allowing for modification of the ongoing trial in the light of accumulating trial data, with new research questions being introduced as amendments rather than as new trials. For example, arms can be added to test new interventions once initial questions have been addressed, while existing arms may be discontinued if it becomes apparent that an intervention is ineffective or harmful based on predefined decision algorithms. Such platform trials can be open-ended and with intervention arms added at different points in time. In particular, the emergence of large adaptive platform trials with pragmatic features embedded into health systems was pivotal in generating evidence for use of therapeutics in coronavirus disease (COVID-19). [...]