The Ebola ça Suffit trial as an example for a pragmatic trial

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Transcription de la présentation:

The Ebola ça Suffit trial as an example for a pragmatic trial With a focus on study design Sven Trelle on behalf of the «Ebola ça Suffit» Trialists CTU Bern University of Bern 08.05.2017, ICTMC & SCT 2017

Preface

Background Explanatory trials Pragmatic trials Explanatory trials: (biological) effects/efficacy Pragmatic trial: evidence for (clinical) decision-making Reality: compromises to increase feasibility Poor science: naivety, sloppiness, ignorance (questionable methods, misconduct) Pragmatic trial ≠ feasible trial i.e. trial conduct adapted to what is possible Pragmatic trials

Ebola ça Suffit trial

Why? The situation at trial «planning»

The Ebola vaccine landscape in 2015 http://www.who.int/mediacentre/events/2015/S2.4_Robinson_ebola_MCM_landscape.pdf?ua=1

Timecourse of the trial with regard to data management

Guinea is not Switzerland …

The trial

Study plan Ici le plan d’étude. Dès qu'un cas est confirmé au centre de traitement, l'anneau est défini et randomisé pour déterminer si la vaccination sera immédiate ou retardée. Tout le monde dans l'anneau est ensuite suivi pour Ebola et pour des événements indésirables graves. Le taux de morbidité d’Ebola est ensuite comparé entre les anneaux avec vaccination immédiate ou avec vaccination retardée.

Ici le plan d’étude. Dès qu'un cas est confirmé au centre de traitement, l'anneau est défini et randomisé pour déterminer si la vaccination sera immédiate ou retardée. Tout le monde dans l'anneau est ensuite suivi pour Ebola et pour des événements indésirables graves. Le taux de morbidité d’Ebola est ensuite comparé entre les anneaux avec vaccination immédiate ou avec vaccination retardée.

Interventions/trial arms Immediate vaccination 1 intramuscular dose of 2 x 10⁷ plaque-forming units of rVSV ZEBOV vaccine (Merck) Delayed vaccination Same but 21 days after inclusion (95% are expected to occur in this time) Decision based on ethical arguments (not for pragmatic reasons; no vaccination or placebo would in theory be preferrable)

So, what is truly pragmatic in this trial?

Definition of vaccination rings and inclusion criteria Laboratory-confirmed EVD cases trigger ring-definition visits. Based on contact tracing and places of residence of the case, an epidemiologically-defined ring is identified. The ring includes contacts and contacts of contacts of the index case. Individuals aged 18 years or older (excluding pregnant women) who live in the defined vaccination ring are offered vaccination.

A hypothetical (small) ring

Here we depict the case and its contacts

Smallpox eradication

Alternatives Standard Cluster Individual randomization Households, villages

Standard of care as benchmark or is the trial setting the standard??? PRECIS-2 Standard of care as benchmark or is the trial setting the standard???

Other pragmatic elements