Key considerations for planning adaptive platform trials: part 1

Anders Granholm; Morten Hylander Møller; Aldana Rosso; Maj-Brit Nørregaard Kjær; Benjamin Skov Kaas-Hansen; Rikke Faebo Larsen; Inger Katrine Dahl-Petersen; Jeanett Friis Rohde; Anders Perner

doi:10.1016/j.jclinepi.2026.112212

Key considerations for planning adaptive platform trials: part 1

Anders Granholm^*, Morten Hylander Møller, Aldana Rosso, Maj-Brit Nørregaard Kjær, Benjamin Skov Kaas-Hansen, Rikke Faebo Larsen, Inger Katrine Dahl-Petersen, Jeanett Friis Rohde, Anders Perner

^*Corresponding author af dette arbejde

Abstract

BACKGROUND AND OBJECTIVES: There is an increased interest in adaptive platform trials (APTs), that is, complex randomized clinical trials (RCTs) focusing on a population or a setting, conducted according to a core protocol, with continuous addition of interventions during trial conduct. APTs may run perpetually, assessing many different interventions. APTs come with benefits regarding increased flexibility, efficiency, and cost-effectiveness compared to conventional, stand-alone RCTs. However, planning APTs is complex, and limited guidance is available.

METHODS: In this two-part series, we provide a narrative overview of key considerations for the planning of APTs in a clinical setting based on our own experiences planning and initiation APTs.

RESULTS: This first part covers the following 5 overall considerations: stakeholder involvement, population and setting, interventions and comparisons, clinical outcomes, and adaptations. The second part covers 7 additional overall considerations: statistics and performance, other design features, data infrastructure, operations and organization, funding, dissemination, and implementation.

CONCLUSION: The provided guidance on key considerations when planning APTs will aid researchers considering or planning APTs.

Originalsprog	Engelsk
Artikelnummer	112212
Tidsskrift	Journal of Clinical Epidemiology
Sider (fra-til)	112212
ISSN	0895-4356
DOI	https://doi.org/10.1016/j.jclinepi.2026.112212
Status	E-pub ahead of print - 6 mar. 2026

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10.1016/j.jclinepi.2026.112212Licens: CC BY

Citationsformater

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title = "Key considerations for planning adaptive platform trials: part 1",

abstract = "BACKGROUND AND OBJECTIVES: There is an increased interest in adaptive platform trials (APTs), that is, complex randomized clinical trials (RCTs) focusing on a population or a setting, conducted according to a core protocol, with continuous addition of interventions during trial conduct. APTs may run perpetually, assessing many different interventions. APTs come with benefits regarding increased flexibility, efficiency, and cost-effectiveness compared to conventional, stand-alone RCTs. However, planning APTs is complex, and limited guidance is available.METHODS: In this two-part series, we provide a narrative overview of key considerations for the planning of APTs in a clinical setting based on our own experiences planning and initiation APTs.RESULTS: This first part covers the following 5 overall considerations: stakeholder involvement, population and setting, interventions and comparisons, clinical outcomes, and adaptations. The second part covers 7 additional overall considerations: statistics and performance, other design features, data infrastructure, operations and organization, funding, dissemination, and implementation.CONCLUSION: The provided guidance on key considerations when planning APTs will aid researchers considering or planning APTs.",

keywords = "Adaptive platform trial, Guidance, Methods, Randomised clinical trial, Stakeholder involvement, Trial design",

author = "Anders Granholm and M{\o}ller, \{Morten Hylander\} and Aldana Rosso and \{N{\o}rregaard Kj{\ae}r\}, Maj-Brit and Kaas-Hansen, \{Benjamin Skov\} and Larsen, \{Rikke Faebo\} and Dahl-Petersen, \{Inger Katrine\} and Rohde, \{Jeanett Friis\} and Anders Perner",

year = "2026",

month = mar,

day = "6",

doi = "10.1016/j.jclinepi.2026.112212",

language = "English",

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journal = "Journal of Clinical Epidemiology",

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TY - JOUR

T1 - Key considerations for planning adaptive platform trials

T2 - part 1

AU - Granholm, Anders

AU - Møller, Morten Hylander

AU - Rosso, Aldana

AU - Nørregaard Kjær, Maj-Brit

AU - Kaas-Hansen, Benjamin Skov

AU - Larsen, Rikke Faebo

AU - Dahl-Petersen, Inger Katrine

AU - Rohde, Jeanett Friis

AU - Perner, Anders

PY - 2026/3/6

Y1 - 2026/3/6

N2 - BACKGROUND AND OBJECTIVES: There is an increased interest in adaptive platform trials (APTs), that is, complex randomized clinical trials (RCTs) focusing on a population or a setting, conducted according to a core protocol, with continuous addition of interventions during trial conduct. APTs may run perpetually, assessing many different interventions. APTs come with benefits regarding increased flexibility, efficiency, and cost-effectiveness compared to conventional, stand-alone RCTs. However, planning APTs is complex, and limited guidance is available.METHODS: In this two-part series, we provide a narrative overview of key considerations for the planning of APTs in a clinical setting based on our own experiences planning and initiation APTs.RESULTS: This first part covers the following 5 overall considerations: stakeholder involvement, population and setting, interventions and comparisons, clinical outcomes, and adaptations. The second part covers 7 additional overall considerations: statistics and performance, other design features, data infrastructure, operations and organization, funding, dissemination, and implementation.CONCLUSION: The provided guidance on key considerations when planning APTs will aid researchers considering or planning APTs.

AB - BACKGROUND AND OBJECTIVES: There is an increased interest in adaptive platform trials (APTs), that is, complex randomized clinical trials (RCTs) focusing on a population or a setting, conducted according to a core protocol, with continuous addition of interventions during trial conduct. APTs may run perpetually, assessing many different interventions. APTs come with benefits regarding increased flexibility, efficiency, and cost-effectiveness compared to conventional, stand-alone RCTs. However, planning APTs is complex, and limited guidance is available.METHODS: In this two-part series, we provide a narrative overview of key considerations for the planning of APTs in a clinical setting based on our own experiences planning and initiation APTs.RESULTS: This first part covers the following 5 overall considerations: stakeholder involvement, population and setting, interventions and comparisons, clinical outcomes, and adaptations. The second part covers 7 additional overall considerations: statistics and performance, other design features, data infrastructure, operations and organization, funding, dissemination, and implementation.CONCLUSION: The provided guidance on key considerations when planning APTs will aid researchers considering or planning APTs.

KW - Adaptive platform trial

KW - Guidance

KW - Methods

KW - Randomised clinical trial

KW - Stakeholder involvement

KW - Trial design

U2 - 10.1016/j.jclinepi.2026.112212

DO - 10.1016/j.jclinepi.2026.112212

M3 - Journal article

C2 - 41796755

SN - 0895-4356

SP - 112212

JO - Journal of Clinical Epidemiology

JF - Journal of Clinical Epidemiology

M1 - 112212

ER -

Key considerations for planning adaptive platform trials: part 1

Abstract

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