Methodological aspects of superiority, equivalence, and non-inferiority trials
| Autor: | D.’Arrigo Graziella, Tripepi Giovanni, Roumeliotis Stefanos |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Coronavirus disease 2019 (COVID-19) Active Comparator business.industry Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Equivalence Trials as Topic 030204 cardiovascular system & hematology Placebo law.invention 03 medical and health sciences 0302 clinical medicine Non inferiority Randomized controlled trial law Untreated control Research Design Emergency Medicine Internal Medicine Physical therapy medicine Humans 030212 general & internal medicine business Equivalence (measure theory) |
| Zdroj: | Internal and emergency medicine. 15(6) |
| ISSN: | 1970-9366 |
| Popis: | Depending on the scientific hypothesis to be addressed, randomized-controlled trials (RCT) are accordingly designed. RCTs that aim to determine whether a novel, experimental therapeutic intervention (either a drug or a treatment) is superior to a placebo or control intervention, are called superiority trials. Less common are the non-inferiority RCTs, designed to assess whether a new intervention is not unacceptably worse than an already existing reference intervention. An equivalence RCT is designed to investigate whether a novel treatment is equivalently effective to another, already existing, control intervention. In equivalence and non-inferiority RCTs, the efficacy of the reference intervention (active comparator) is already established, and therefore, an untreated control group would not be ethical. In this review, using a series of examples derived from equivalence and non-inferiority/superiority RCTs, we describe the main differences and methodological aspects among these three different types of RCTs. |
| Databáze: | OpenAIRE |
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