Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.1 - Platform, basket and umbrella trials: Difference between revisions
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| | | [[Glossary:TAG-00302-Ada-die|Adaptive design]], [[Glossary:TAG-00033-Pro-oto|Protocol]], [[Glossary:TAG-00277-Pla-par|Placebo]], [[Glossary:TAG-00055-Stu-ngs|Study design]] | ||
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Revision as of 17:29, 15 July 2026
| 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 |
| Comment | Platform, basket and umbrella trials: master protocol concept |
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). [...]
