Recommendations for planning and conducting clinical trials with master protocol designs: Umbrella, Basket and Platform Trials

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.

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Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2025-07-18
DOI
https://doi.org/10.5281/zenodo.16086604
Primary Topic
Statistical Methods in Clinical Trials
Type
article
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article

Recommendations for planning and conducting clinical trials with master protocol designs: Umbrella, Basket and Platform Trials

Zenodo (CERN European Organization for Nuclear Research)
Statistical Methods in Clinical Trials
article

Recommendations for planning and conducting clinical trials with master protocol designs: Umbrella, Basket and Platform Trials

article en

Abstract

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.

Zenodo (CERN European Organization for Nuclear Research)
University of Pavol Jozef Šafárik (SK), University College Cork (IE), Istituto Superiore di Sanità (IT), European Clinical Research Infrastructure Network (FR), Universidade Nova de Lisboa (PT)
Openalex Percentile: Top 61%
Statistical Methods in Clinical Trials
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