Consequences of Inaccurate Assumptions in Coronary Stent Noninferiority Trials: A Systematic Review and Meta-analysis.
Sign Up to like & getrecommendations! Published in 2022 at "JAMA cardiology"
DOI: 10.1001/jamacardio.2021.5724
Abstract: Importance The outcome and interpretation of noninferiority trials depend on the magnitude of the noninferiority margin and whether a relative or absolute noninferiority margin is used and may be affected by imprecision in event rate… read more here.
Keywords: noninferiority; margin; noninferiority margin; event rate ... See more keywords
Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011
Sign Up to like & getrecommendations! Published in 2017 at "JAMA Internal Medicine"
DOI: 10.1001/jamainternmed.2017.3820
Abstract: Importance Potential research participants may assume that randomized trials comparing new interventions with older interventions always hypothesize greater efficacy for the new intervention, as in superiority trials. However, antibiotic trials frequently use “noninferiority” hypotheses allowing… read more here.
Keywords: study purpose; randomized clinical; study; noninferiority ... See more keywords
Demonstrating Noninferiority of Accelerated Radiotherapy With Panitumumab vs Standard Radiotherapy With Cisplatin in Locoregionally Advanced Squamous Cell Head and Neck Carcinoma.
Sign Up to like & getrecommendations! Published in 2017 at "JAMA oncology"
DOI: 10.1001/jamaoncol.2017.0737
Abstract: Demonstrating Noninferiority of Accelerated Radiotherapy With Panitumumab vs Standard Radiotherapy With Cisplatin in Locoregionally Advanced Squamous Cell Head and Neck Carcinoma To the Editor Siu and colleagues1 conducted the largest clinical trial to date to… read more here.
Keywords: plus panitumumab; radiotherapy; afx plus; plus cisplatin ... See more keywords
Design and Interpretation of Noninferiority Trials
Sign Up to like & getrecommendations! Published in 2018 at "Journal of General Internal Medicine"
DOI: 10.1007/s11606-018-4505-8
Abstract: A uthors’ reply: We are grateful for the correspondents’ interest in our descriptive study of noninferiority trials.1 Turgeon et al. have retrospectively extended the part of our analysis comparing ITT (intention-to-treat) and PP (perprotocol) methodologies… read more here.
Keywords: medicine; design interpretation; interpretation noninferiority; noninferiority ... See more keywords
Non-inferiority Trial Design in Drug Development: A Primer for Cardiovascular Healthcare Professionals
Sign Up to like & getrecommendations! Published in 2019 at "American Journal of Cardiovascular Drugs"
DOI: 10.1007/s40256-019-00378-w
Abstract: Noninferiority trials, in which a new treatment is compared with a standard active treatment, are becoming increasingly popular in cardiovascular medicine. A noninferiority trial seeks to test whether the effect of a new drug is… read more here.
Keywords: medicine; trial; design; drug ... See more keywords
Using a single noninferiority margin or preserved fraction for an entire pharmacological class was found to be inappropriate.
Sign Up to like & getrecommendations! Published in 2018 at "Journal of clinical epidemiology"
DOI: 10.1016/j.jclinepi.2018.07.004
Abstract: OBJECTIVE To assess the impact on noninferiority decisions when using a single margin or single preserved fraction (PF) for all noninferiority trials within a pharmacological class. STUDY DESIGN AND SETTING A search in PubMed, EMBASE,… read more here.
Keywords: using single; noninferiority; single margin; pharmacological class ... See more keywords
A sequential approach for noninferiority or equivalence of a linear contrast under cost constraints.
Sign Up to like & getrecommendations! Published in 2023 at "Psychological methods"
DOI: 10.1037/met0000570
Abstract: Planning an appropriate sample size for a study involves considering several issues. Two important considerations are cost constraints and variability inherent in the population from which data will be sampled. Methodologists have developed sample size… read more here.
Keywords: noninferiority; cost constraints; equivalence; linear contrast ... See more keywords
Sample size calculations for noninferiority trials for time-to-event data using the concept of proportional time
Sign Up to like & getrecommendations! Published in 2020 at "Journal of Applied Statistics"
DOI: 10.1080/02664763.2020.1753026
Abstract: Noninferiority trials intend to show that a new treatment is ‘not worse' than a standard-of-care active control and can be used as an alternative when it is likely to cause fewer side effects compared to… read more here.
Keywords: sample size; time; time event; noninferiority ... See more keywords
Statistical design of noninferiority multiple region clinical trials to assess global and consistent treatment effects
Sign Up to like & getrecommendations! Published in 2017 at "Journal of Biopharmaceutical Statistics"
DOI: 10.1080/10543406.2017.1293075
Abstract: ABSTRACT Noninferiority multiregional clinical trials (MRCTs) have recently received increasing attention in drug development. While a major goal in an MRCT is to estimate the global treatment effect, it is also important to assess the… read more here.
Keywords: statistical design; treatment; clinical trials; consistency ... See more keywords
Incorporating a companion test into the noninferiority design of medical device trials
Sign Up to like & getrecommendations! Published in 2019 at "Journal of Biopharmaceutical Statistics"
DOI: 10.1080/10543406.2018.1489403
Abstract: ABSTRACT Noninferiority trials are commonly utilized to evaluate the safety and effectiveness of medical devices. It could happen that the noninferiority hypothesis is rejected while the performance of the active control is clinically not satisfactory.… read more here.
Keywords: companion test; design; device; noninferiority ... See more keywords
Approaches for testing noninferiority in two-arm trials for risk ratio and odds ratio
Sign Up to like & getrecommendations! Published in 2019 at "Journal of Biopharmaceutical Statistics"
DOI: 10.1080/10543406.2019.1572616
Abstract: ABSTRACT For an existing established drug regimen, active control trials are defacto standard due to ethical reason as well as for clinical equipoise. However, when superiority claim of a new drug against the active control… read more here.
Keywords: two arm; arm trials; odds ratio; noninferiority ... See more keywords