Randomisation in a clinical trial: is it feasible in the Ebola crisis? If it is, then which method is suitable?

Abstract

Randomisation is an integral component of any sensible clinical trial. Randomisation is the only way we can be sure that the patients have been allocated into the treatment arms with as minimum bias as possible, and that the treatment arms are similar before the start of the trial. The randomisation schemes used to allocate patients into the treatment arms play a role in achieving this goal. This study is motivated by the outbreak of Ebola in West Africa. Scientists claim to have developed some cure for the deadly disease. The question is: ‘Ethically, can the trials be non-randomised due to the crisis? If the trials are to be randomised, which randomisation method is suitable?’ An overview of the randomisation methods was done and recommended stratified randomisation of Ebola patients between any new treatment and the conventional care is provided. Each of the involved countries or centres was treated as the strata and, within each stratum, simple randomisation was then performed.

Keywords

• ebola
• placebo
• prognostic factors
• randomisation
• statistical power