Evaluation by simulation of clinical trial designs for evaluation of treatment during a viral haemorrhagic fever outbreak.

ABSTRACT:

Background

Viral haemorrhagic fevers are characterized by irregular outbreaks with high mortality rate. Difficulties arise when implementing therapeutic trials in this context. The outbreak duration is hard to predict and can be short compared to delays of trial launch and number of subject needed (NSN) recruitment. Our objectives were to compare, using clinical trial simulation, different trial designs for experimental treatment evaluation in various outbreak scenarios.

Methods

Four type of designs were compared: fixed or group-sequential, each being single- or two-arm. The primary outcome was 14-day survival rate. For single-arm designs, results were compared to a pre-trial historical survival rate p_H. Treatments efficacy was evaluated by one-sided tests of prop

SUBMITTER: Manchon P 

PROVIDER: S-EPMC8099711 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature