Current state-of-the-art and gaps in platform trials: 10 things you should know, insights from EU-PEARL

F Koenig, C Spiertz, D Millar… - …, 2024 - thelancet.com
Platform trials bring the promise of making clinical research more efficient and more patient
centric. While their use has become more widespread, including their prominent role during …

On the use of non-concurrent controls in platform trials: a scoping review

M Bofill Roig, C Burgwinkel, U Garczarek, F Koenig… - Trials, 2023 - Springer
Background Platform trials gained popularity during the last few years as they increase
flexibility compared to multi-arm trials by allowing new experimental arms entering when the …

On model-based time trend adjustments in platform trials with non-concurrent controls

M Bofill Roig, P Krotka, CF Burman, E Glimm… - BMC medical research …, 2022 - Springer
Background Platform trials can evaluate the efficacy of several experimental treatments
compared to a control. The number of experimental treatments is not fixed, as arms may be …

A blueprint for a multi-disease, multi-domain Bayesian adaptive platform trial incorporating adult and paediatric subgroups: the Staphylococcus aureus Network …

RK Mahar, A McGlothlin, M Dymock, TC Lee, RJ Lewis… - Trials, 2023 - Springer
Abstract The Staphylococcus aureus Network Adaptive Platform (SNAP) trial is a
multifactorial Bayesian adaptive platform trial that aims to improve the way that S. aureus …

[HTML][HTML] Ivermectin for COVID-19 in adults in the community (PRINCIPLE): An open, randomised, controlled, adaptive platform trial of short-and longer-term outcomes

G Hayward, LM Yu, P Little, O Gbinigie, M Shanyinde… - Journal of Infection, 2024 - Elsevier
Background The evidence for whether ivermectin impacts recovery, hospital admissions,
and longer-term outcomes in COVID-19 is contested. The WHO recommends its use only in …

Considerations for master protocols using external controls

J Chen, X Li, C Lu, S Yuan, G Yung, J Ye… - Journal of …, 2024 - Taylor & Francis
There has been an increasing use of master protocols in oncology clinical trials because of
its efficiency to accelerate cancer drug development and flexibility to accommodate multiple …

Statistical considerations for the platform trial in COVID-19 vaccine priming and boosting

M Dymock, C McLeod, P Richmond, T Snelling… - Trials, 2024 - Springer
Abstract The Platform trial In COVID-19 priming and BOOsting (PICOBOO) is a multi-site,
adaptive platform trial designed to generate evidence of the immunogenicity, reactogenicity …

[HTML][HTML] Platform trials for anaesthesia and perioperative medicine: a narrative review

PS Myles, J Yeung, WS Beattie, EG Ryan… - British Journal of …, 2023 - Elsevier
Large randomised trials provide the most reliable evidence of effectiveness of new
treatments in clinical practice. However, the time and resources required to complete such …

Regulatory Issues of Platform Trials: Learnings from EU‐PEARL

QL Nguyen, K Hees… - Clinical …, 2024 - Wiley Online Library
Although platform trials have many benefits, the complexity of these designs may result not
only in increased methodological but also regulatory and ethical challenges. These aspects …

The impact of heterogeneity on the analysis of platform trials with normally distributed outcomes

KM Lee, R Emsley - BMC Medical Research Methodology, 2024 - Springer
Background A platform trial approach allows adding arms to on-going trials to speed up
intervention discovery programs. A control arm remains open for recruitment in a platform …