Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011.

ABSTRACT:

Importance

Potential research participants may assume that randomized trials comparing new interventions with older interventions always hypothesize greater efficacy for the new intervention, as in superiority trials. However, antibiotic trials frequently use "noninferiority" hypotheses allowing a degree of inferior efficacy deemed "clinically acceptable" compared with an older effective drug, in exchange for nonefficacy benefits (eg, decreased adverse effects). Considering these different benefit-harm trade-offs, proper informed consent necessitates supplying different information on the purposes of superiority and noninferiority trials.

Objective

To determine the degree to which the study purpose is explained to potential participants in randomized clinical trials of antib

SUBMITTER: Doshi P 

PROVIDER: S-EPMC5710221 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature