An introductory note to the CHMP guidelines: choice of the non‐inferiority margin and data monitoring committees by David Brown, Peter Volkers and Simon Day, <i>Statistics in Medicine</i> 2006; <b>25</b>:1623–1627

Hauschke, Dieter; Hothorn, Ludwig A.

doi:10.1002/sim.2665

Cited by 11 publications

(1 citation statement)

References 9 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Several approaches for the choice of non‐inferiority margins are available . Functions of differences or ratios between the active control and placebo are common in historical trials. Two‐sided intervals actually mean a switch into equivalence hypotheses, which represents a rather specific problem in the analysis of multi‐arm trials (see , for example).…”

Section: Introduction and Basic Problemsmentioning

confidence: 99%

Simultaneous confidence intervals on multivariate non‐inferiority

Hasler

Hothorn

2012

Statistics in Medicine

View full text Add to dashboard Cite

We discuss the analysis of non-inferiority trials based on a multi-armed design with multiple correlated endpoints. We consider five different scenarios: (1) global non-inferiority; (2) non-inferiority for subsets of comparisons; (3) global non-inferiority for a treatment group; (4) global non-inferiority for an endpoint; and (5) local non-inferiority. We describe and compare related approaches, which are based on the union-intersection and intersection-union test principles - alone and in combination. Because non-inferiority thresholds for many differently scaled endpoints are rarely available in practice, the approaches described focus on the estimation of simultaneous confidence limits and their post hoc interpretation on non-inferiority. We discuss and demonstrate pros and cons by means of a real data example.

show abstract

Section: Introduction and Basic Problemsmentioning

confidence: 99%

Simultaneous confidence intervals on multivariate non‐inferiority

Hasler

Hothorn

2012

Statistics in Medicine

View full text Add to dashboard Cite

show abstract

Reporting of Noninferiority and Equivalence Randomized Trials

Piaggio¹,

Elbourne²,

Pocock³

et al. 2012

JAMA

1,406

914

View full text Add to dashboard Cite

The CONSORT (Consolidated Standards of Reporting Trials) Statement, which includes a checklist and a flow diagram, is a guideline developed to help authors improve the reporting of the findings from randomized controlled trials. It was updated most recently in 2010. Its primary focus is on individually randomized trials with 2 parallel groups that assess the possible superiority of one treatment compared with another. The CONSORT Statement has been extended to other trial designs such as cluster randomization, and recommendations for noninferiority and equivalence trials were made in 2006. In this article, we present an updated extension of the CONSORT checklist for reporting noninferiority and equivalence trials, based on the 2010 version of the CONSORT Statement and the 2008 CONSORT Statement for the reporting of abstracts, and provide illustrative examples and explanations for those items that differ from the main 2010 CONSORT checklist. The intent is to improve reporting of noninferiority and equivalence trials, enabling readers to assess the reliability of their results and conclusions.

show abstract

Reporting of Noninferiority and Equivalence Randomized Trials

Piaggio¹,

Elbourne²,

Altman³

et al. 2006

JAMA

1,136

929

View full text Add to dashboard Cite

The CONSORT (Consolidated Standards of Reporting Trials) Statement, including a checklist and a flow diagram, was developed to help authors improve their reporting of randomized controlled trials. Its primary focus was on individually randomized trials with 2 parallel groups that assess the possible superiority of one treatment compared with another but is now being extended to other trial designs. Noninferiority and equivalence trials have methodological features that differ from superiority trials and present particular difficulties in design, conduct, analysis, and interpretation. Although the rationale for such trials occurs frequently, those designed and described specifically as noninferiority or equivalence trials appear less commonly in the medical literature. The quality of reporting of those that are published is often inadequate. In this article, we present an adapted CONSORT checklist for reporting noninferiority and equivalence trials and provide illustrative examples and explanations for those items amended from the original CONSORT checklist. The intent is to improve reporting of noninferiority and equivalence trials, enabling readers to assess the validity of their results and conclusions.

show abstract

An introductory note to the CHMP guidelines: choice of the non‐inferiority margin and data monitoring committees by David Brown, Peter Volkers and Simon Day, Statistics in Medicine 2006; 25:1623–1627

Cited by 11 publications

References 9 publications

Simultaneous confidence intervals on multivariate non‐inferiority

Simultaneous confidence intervals on multivariate non‐inferiority

Reporting of Noninferiority and Equivalence Randomized Trials

Reporting of Noninferiority and Equivalence Randomized Trials

Contact Info

Product

Resources

About