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 …
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 …
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 …
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 …
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 …
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 …
and longer-term outcomes in COVID-19 is contested. The WHO recommends its use only in …
Considerations for master protocols using external controls
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 …
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
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 …
adaptive platform trial designed to generate evidence of the immunogenicity, reactogenicity …
[HTML][HTML] Platform trials for anaesthesia and perioperative medicine: a narrative review
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 …
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 …
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
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 …
intervention discovery programs. A control arm remains open for recruitment in a platform …