Published July 18, 2025
| Version v1
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Recommendations for planning and conducting clinical trials with master protocol designs: Umbrella, Basket and Platform Trials
Creators
- 1. European Clinical Research Infrastructure Network (ECRIN)
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2.
Universidade Nova de Lisboa
- 3. ECRIN (European Clinical Research Infrastructure Network)
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4.
Istituto Superiore di Sanità
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5.
European Clinical Research Infrastructure Network
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6.
University College Cork
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7.
Czech National Node to the European Clinical Research Infrastructure Network
- 8. Pavol Jozef Šafárik University in Košice
- 9. ECRIN
Description
The aim of this booklet is to offer a comprehensive overview of the key aspects of new trial methodologies and to provide solutions to the main challenges in developing, implementing and conducting trials with new designs namely master protocol with umbrella, basket, and adaptive platform design.
This booklet has been adapted from ERA4Health’s original document D14.2 “Recommendation booklet for investigators and sponsors in multi-country investigator initiated clinical studies”. References cited in this document can be found at the original source.
Files
ERA4Health booklet Master protocol designs.pdf
Files
(2.9 MB)
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Additional details
Related works
- Has part
- 10.5281/zenodo.16093673 (DOI)