Understanding superiority, noninferiority, and equivalence for clinical trials
Rahul Mahajan, Kamal Kishore
Abstract
Randomized control trialsare the gold standard for testing the efficacy of new interventions. Historically, superiority trials were methods of choice as reference (standard) interventions were not established for many disease conditions. However currently, reference interventions are available for most of adverse conditions. Despite this, many investigators are using superiority trials in comparison to more suitable noninferiority and equivalence trials. The application of noninferiority and equivalence trials is on the rise, but by and large, these trials are poorly understood, ill-conceived, inappropriately analyzed, and reported and misinterpreted.
Topics & Concepts
MedicineEquivalence (formal languages)Psychological interventionClinical trialGold standard (test)Intensive care medicineRandomized controlled trialAdverse effectMedical physicsSurgeryInternal medicinePsychiatryLinguisticsPhilosophyStatistical Methods in Clinical TrialsHealth Systems, Economic Evaluations, Quality of LifeAdvanced Causal Inference Techniques