Clinical Trials
Volume 17 Issue 2, April 2020
https://journals.sagepub.com/toc/ctja/17/1
Articles
Non-inferiority designs comparing placebo to a proven therapy for childhood pneumonia in low-resource settings
After a new treatment is recommended to be first-line treatment for a specific indication, outcome and population, it may be unethical to use placebo as a comparator in trials for that setting. Nevertheless, in specific circumstances, use of a placebo group might be warranted, for example, when it is believed that an active treatment may not be efficacious or cost-effective for a specific subpopulation. An example is antibiotic treatment for pneumonia, which may not be effective for many patients taking it due to the emergence of antibiotic-resistant strains or the high prevalence of viral and low prevalence of bacterial pneumonia.
Susanne May, Siobhan P Brown, Robert H Schmicker, Scott S. Emerson, Evangelyn Nkwopara, Amy Sarah Ginsburg
First Published December 8, 2019; pp. 129–137