WHAT A PHARMACIST/PRACTITIONER SHOULD KNOW ABOUT EVALUATING NONINFERIORITY TRIALS
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Abstract
Noninferiority trials attempt to prove noninferiority of test therapy over existing standard treatment and are a prominent component of modern drug testing and approval. It is essential that pharmacists and practitioners of evidence-based medicine can critically evaluate these studies for strengths, weaknesses, and applicability to patient care. This review aims to present a question-based (questionnaire) approach of how to evaluate the minutiae of noninferiority trials, adapted from CONSORT (Consolidated Standards of Reporting Trials) Guidelines and its extensions for evaluating noninferiority trial and other regulatory guidance documents. An illustrative example of using such a questionnaire is provided to help practitioners evaluate a published noninferiority trial prior to applying the results to patient care.
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