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Novel Antibiotics May Be Noninferior but Are They Becoming Less Effective?: a Systematic Review.


ABSTRACT: Novel antibiotics approved by noninferiority trials may become less effective over time in two scenarios: (i) the treatment effect in studies of novel antibiotics may be consistently worse than studies of older antibiotics; (ii) when a decreasingly effective control arm is used in a series of noninferiority trials. Our systematic review of 175 noninferiority antibiotic trials found these scenarios to be rare.

SUBMITTER: Bai AD 

PROVIDER: S-EPMC7577162 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Novel Antibiotics May Be Noninferior but Are They Becoming Less Effective?: a Systematic Review.

Bai Anthony D AD   Komorowski Adam S AS   Lo Carson K L CKL   Tandon Pranav P   Li Xena X XX   Mokashi Vaibhav V   Cvetkovic Anna A   Findlater Aidan A   Liang Laurel L   Loeb Mark M   Mertz Dominik D  

Antimicrobial agents and chemotherapy 20201020 11


Novel antibiotics approved by noninferiority trials may become less effective over time in two scenarios: (i) the treatment effect in studies of novel antibiotics may be consistently worse than studies of older antibiotics; (ii) when a decreasingly effective control arm is used in a series of noninferiority trials. Our systematic review of 175 noninferiority antibiotic trials found these scenarios to be rare. ...[more]

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