%0 Journal Article %1 Angeli2020 %A Angeli, Fabio %A Verdecchia, Paolo %A Vaudo, Gaetano %A Masnaghetti, Sergio %A Reboldi, Gianpaolo %D 2020 %I Adis %J Pharmaceutical Medicine %K DataAccuracy DataInterpretation EndpointDetermination EquivalenceTrialsasTopic* FabioAngeli GianpaoloReboldi Humans MEDLINE NCBI NIH NLM NationalCenterforBiotechnologyInformation NationalInstitutesofHealth NationalLibraryofMedicine PaoloVerdecchia PubMedAbstract ResearchDesign* Review Statistical TreatmentOutcome doi:10.1007/s40290-020-00334-z pmid:32277352 %N 3 %P 159-165 %R 10.1007/s40290-020-00334-z %T Optimal Use of the Non-Inferiority Trial Design %U https://pubmed.ncbi.nlm.nih.gov/32277352/ %V 34 %X Superiority trials are conducted to test the hypothesis that a treatment or strategy A is superior to (i.e., better than) treatment strategy B in reducing the impact of disease. However, A may be considerably safer, more convenient, or cheaper than B. These features may make A more attractive than B even if the burden of disease is reduced comparably by the two treatments, or even a bit worse by A over B. In this context, non-inferiority trials have become increasingly popular to test the hypothesis that a new treatment is not ‘unacceptably worse’ than an active comparator by more than a predefined non-inferiority margin. Non-inferiority trials have unique design features and methodology and require a different analysis than traditional superiority trials. The main aim of this overview is to analyze the role of non-inferiority trials in the development of new treatments, involving some scientific, statistical, and practical considerations. We elucidate some aspects of non-inferiority trials that contribute to the validity of the results. The unique design features and methodology of non-inferiority trials are summarized and key findings to consider when evaluating a non-inferiority trial are illustrated.

@article{Angeli2020, abstract = {Superiority trials are conducted to test the hypothesis that a treatment or strategy A is superior to (i.e., better than) treatment strategy B in reducing the impact of disease. However, A may be considerably safer, more convenient, or cheaper than B. These features may make A more attractive than B even if the burden of disease is reduced comparably by the two treatments, or even a bit worse by A over B. In this context, non-inferiority trials have become increasingly popular to test the hypothesis that a new treatment is not ‘unacceptably worse’ than an active comparator by more than a predefined non-inferiority margin. Non-inferiority trials have unique design features and methodology and require a different analysis than traditional superiority trials. The main aim of this overview is to analyze the role of non-inferiority trials in the development of new treatments, involving some scientific, statistical, and practical considerations. We elucidate some aspects of non-inferiority trials that contribute to the validity of the results. The unique design features and methodology of non-inferiority trials are summarized and key findings to consider when evaluating a non-inferiority trial are illustrated.}, added-at = {2023-02-03T11:44:35.000+0100}, author = {Angeli, Fabio and Verdecchia, Paolo and Vaudo, Gaetano and Masnaghetti, Sergio and Reboldi, Gianpaolo}, biburl = {https://www.bibsonomy.org/bibtex/263cfb46412fcb5806c56f5a03847dd12/jepcastel}, doi = {10.1007/s40290-020-00334-z}, interhash = {384adeec1f812ff253e1b9a5a5492f0c}, intrahash = {63cfb46412fcb5806c56f5a03847dd12}, issn = {11791993}, journal = {Pharmaceutical Medicine}, keywords = {DataAccuracy DataInterpretation EndpointDetermination EquivalenceTrialsasTopic* FabioAngeli GianpaoloReboldi Humans MEDLINE NCBI NIH NLM NationalCenterforBiotechnologyInformation NationalInstitutesofHealth NationalLibraryofMedicine PaoloVerdecchia PubMedAbstract ResearchDesign* Review Statistical TreatmentOutcome doi:10.1007/s40290-020-00334-z pmid:32277352}, month = {6}, note = {Tests d'equivalència; Introductori; Critical appraisal}, number = 3, pages = {159-165}, pmid = {32277352}, publisher = {Adis}, timestamp = {2023-02-03T11:44:35.000+0100}, title = {Optimal Use of the Non-Inferiority Trial Design}, url = {https://pubmed.ncbi.nlm.nih.gov/32277352/}, volume = 34, year = 2020 }