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Category:
Life Science

Lecturer:
Harriet Sommer, Roche Pharma AG, Grenzach-Wyhlen

Place:
ATV-Raum des DKFZ, Im Neuenheimer Feld 242

Host:
Heidelberger Kolloquium Medizinische Biometrie, Informatik und Epidemiologie

Description:
In clinical trials for the development of antibacterial drugs, diverse primary endpoints have been used and treatment effects are usually assessed at the end of follow-up which varies between studies. A highly patient-relevant statement would be an assessment over the entire follow-up period with cure and death as co-primary endpoints. We emphasise to examine the time-dependent multistate endpoint “get cured and stay alive over time”, since this might be most relevant from the patients’ perspective and can capture different “cure patterns” over the treatment period [1,2,3]. Such time-dynamic endpoints provide valuable additional information such that potentially hidden treatment effects can be revealed that might be overlooked when only presenting incidence proportions. Based on a “cure-death” multistate model, several possibilities are introduced to evaluate a treatment difference in probabilities to be cured and alive over time. The procedures are applied to three topical data examples: An RCT by Basilea for the treatment of patients with hospital-acquired pneumonia (see also [1] and [4]), an RCT by Merck for the prevention of recurrent Clostridium difficile infection (see also [5]), and the French prospective OUTCOMEREA database to investigate the effect of early adequate treatment on extubation and discharge for patients with ventilator-associated pneumonia due to the pathogen Pseudomonas aeruginosa (see also [6]) [1] H Sommer et.al, Pharmaceutical Statistics, 16:267–279, 2017. [2] JF Timsit et.al, Intensive Care Medicine, 43:1002–1012, 2017. [3] MEA de Kraker et.al, Clinical Infectious Diseases, 67(12):1922–1931, 2018. [4] H Sommer et.al, Antimicrobial Agents and Chemotherapy, 62:e01691–17, 2018. [5] H Sommer et.al, New England Journal of Medicine (letter to the editor), 376:1594–1595, 2017. [6] H Sommer et.al, Critical Care Medicine, 46:1643–1648, 2018.

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