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Home Science and Research Clinical Research Collaboration: application programme PANTHER – Precision medicine Adaptive Network platform Trial in Hypoxemic acutE respiratory failuRe

PANTHER – Precision medicine Adaptive Network platform Trial in Hypoxemic acutE respiratory failuRe

CRC Chairs:
Lieuwe Bos (Amsterdam UMC, Amsterdam, Netherlands)
Danny McAuley (Queen's University Belfast, Belfast, United Kingdom)

About PANTHER

The PANTHER (Precision medicine Adaptive Network platform Trial in Hypoxemic acutE respiratory failuRe) clinical research collaboration (CRC) was launched by the European Respiratory Society (ERS) in 2023.

The acute respiratory distress syndrome (ARDS) is a heterogeneous clinical syndrome characterised by acute diffuse, inflammatory lung injury resulting in acute hypoxaemic respiratory failure due to noncardiogenic pulmonary oedema. ARDS has a significant global burden and high mortality. No effective pharmacological treatment is currently available, likely due to clinical and biological heterogeneity.

Considerable recent progress has been made towards identifying biological ARDS phenotypes that appear to respond differently to specific interventions in secondary analysis of completed randomised controlled trials. These phenotypes are largely distinguishable by inflammatory biomarkers, suggesting that patients with a specific phenotype may have a more homogeneous inflammatory response. This CRC aims to design an adaptive platform trial which stratifies ARDS patients based on their biological phenotype, enabling a “precision medicine” approach to the pharmacological management of ARDS.

Using near-patient biological testing, these biological phenotypes can now be accurately classified in real-time, facilitating stratified randomisation in a precision medicine trial. As an alternative approach, clinical data may also be used in a machine learning analysis to identify the phenotypes. The proposed trial design will enrol patients with both hyper and hypo-inflammatory ARDS phenotypes, stratifying patients in realtime.

Specific aims

The vision of the PANTHER CRC is to support the development of an international precision medicine platform trial, aiming to efficiently test several pharmacological interventions in hyper-inflammatory and hypo-inflammatory phenotypes in ARDS.

With this purpose, the PANTHER CRC aims specifically to:

  • Define sub phenotypes to target and intervene on.
  • Design and implement a Bayesian trial design to effectively determine the rules for adaptation and target sample size.
  • Build research capacity through engagement with early career researchers participating in research, including within low- and middle-income countries (LMICs), which will also help to enhance diversity within the research team.
  • Establish an effective interaction with industry to allow for funding of the trial and ensure trial quality is sufficient for regulators to allow for commercialisation.
  • Answer secondary hypothesis and explain counterintuitive findings using stored biospecimens.
  • Establish a critical care precision medicine PPI and Equality, Diversity, and Inclusion (EDI) working group with patient, public and investigator representation for all participating regions.

 

Stakeholders

The CRC PANTHER is composed of the CRC Chairs, experts in clinical research, early career members, patient representatives and pharma partners.

Contact

If you are interested in more information about the CRC PANTHER or would like to join the network, please contact scientific@ersnet.org.