Intervention Prioritisation

This page includes information on PANTHER interventions. Find information here on how to propose a new intervention; the assessment criteria and what interventions are currently active in the trial

Assessment criteria

Candidate interventions are discussed and assessed by the platform intervention selection committee based on the criteria set out below.

1 - Evidence base

    • Is there evidence of a differential response to the proposed intervention among sub-phenotypes of ARDS?

    Levels:

    • Pre-clinical
    • Observational
    • Re-analysis of a randomised controlled trial

    Grades: Strong, moderate, or weak

    • Are these sub-phenotypes consistent with the PANTHER platforms approach to stratification?
    • Is there sufficient evidence to suggest the mechanism by which the intervention exerts benefit and is further investigation of this mechanism tractable within the platform?
    • Is there evidence of efficacy in ARDS?

    Levels:

    • Pre-clinical
    • Observational
    • Randomised controlled trial

    Grades: Strong, moderate, or weak

    • Is there evidence of efficacy in COVID-19 ARDS?

    Levels:

    • Pre-clinical
    • Observational
    • Randomised controlled trial

    Grades: Strong, moderate, or weak

    • Is there evidence of efficacy in an inflammatory condition related to ARDS?

    Levels:

    • Pre-clinical
    • Observational
    • Randomised controlled trial

    Grades: Strong, moderate, or weak

    • Does sufficient mechanistic data exist to show that similar effects could reasonably be expected in an ARDS sub-phenotype?

2 - Safety and pharmacology data

    • At what phase of development is the intervention?
    • Does the intervention have important cautions or contraindications?
    • Does the intervention have important interactions?
    • What are the common or important side-effects?
    • Is a reversal agent available?
    • Is robust PK/PD data available?
    • If so, are data specific to a critical illness population? Do these data extend to patients in receipt of RRT and/or ECMO?

3 - Feasibility

    • Is there a formulation of the intervention that is suitable for administration to critically ill and mechanically ventilated patients?
    • Does the proposed intervention require special preparation, storage or handling?
    • What is the anticipated duration of the intervention and what is the dosing schedule?
    • Is the supply of the intervention scalable to an international, multi-centre study?
    • Can the supply of the intervention be guaranteed for the anticipated duration of recruitment?
    • For repurposed interventions, what is the prevalence of use in the population that the trial seeks to include?
    • Does the intervention require therapeutic drug monitoring?
    • Does the intervention require the use of an additional biomarker to guide administration?
    • Are there ongoing or planned studies of the intervention in the same or a similar population? If so, would inclusion of the intervention in PANTHER be likely to offer novel or superior information?