An introduction to multiplicity issues in clinical trials

Traditional multiplicity adjustment methods in clinical trials. - Abstract

If unaddressed, problems of multiplicity can undermine integrity of statistical inferences. The tutorial reviews key concepts in multiple hypothesis testing and ...

Some Thoughts on Clinical Trials, Especially Problems of Multiplicity

PETO, R, DESIGN AND ANALYSIS OF RANDOMIZED CLINICAL-TRIALS REQUIRING PROLONGED OBSERVATION OF EACH PATIENT .1. INTRODUCTION AND DESIGN, BRITISH JOURNAL OF ...

Multiple Endpoints in Clinical Trials - Guidance for Industry - FDA

... Multiplicity issues in clinical trials with. 68 multiple objectives, Statistics in Biopharmaceutical Research, 5(4): 321-337. 69. 70. Guidance for industry E9 ...

Tukey, John W. "Some Thoughts on Clinical Trials, Especially ...

Tukey, John W. "Some Thoughts on Clinical Trials, Especially Problems of Multiplicity." Science 198, 18 November 1977: 679-684 · Contents · Get access · More · Cite ...

Key Multiplicity Issues in Clinical Trials (Part I): Module F - YouTube

Module F: Simultaneous confidence intervals for commonly used multiple testing procedures (single-step and stepwise procedures).

Practical Guidelines for Multiplicity Adjustment in Clinical Trials

Control Clin Trials 2000;21:527–539. Introduction. One of the more controversial issues among clinical trialists today is that of multiplicity adjustment.

‪Alex Dmitrienko‬ - ‪Google Scholar‬

Traditional multiplicity adjustment methods in clinical trials. A ... 2014. Key multiplicity issues in clinical drug development. A Dmitrienko, RB D ...

Contemporary Clinical Trials - St George's, University of London

The key issue in determining whether to control for multiplicity is whether multiple tests are conceptually related: that is, how separate are.

Key Multiplicity Issues in Clinical Trials (Part I) - YouTube

The online training course gives a comprehensive overview of traditional multiplicity problems with a single source of multiplicity in clinical trials.

EU regulatory guidance on multiplicity issues and missing data

clinical trials offer many natural opportunities for multiplicity, but beyond this, choice may be introduced in a subtle way… 6. PtC on multiplicity issues in ...

Characteristics of the Multiplicity of Randomized Clinical Trials for ...

... issues of incomplete participant accrual and publication bias that are introduced by enabling dozens of similar trials simultaneously.

Guideline on Multiplicity Issues in Clinical Trials (Final)

A primary endpoint is an endpoint that is directly related to the primary concern (primary objective) of the clinical trial and that provides the most ...

Full article: Optimizing Graphical Procedures for Multiplicity Control ...

1 Introduction. Most clinical trials performed in drug development contain multiple endpoints to assess the effects of the drug and to document the ability of ...

Multiple testing problems in pharmaceutical statistics

In each chapter, the expert contributors describe important multiplicity problems encountered in pre-clinical and clinical trial settings. The ...

Best (but oft-forgotten) practices: the multiple problems of multiplicity ...

Testing many null hypotheses in a single study results in an increased probability of detecting a significant finding just by chance (the problem of ...

Approaches to multiplicity in publicly funded pragmatic randomised ...

An introduction to multiplicity issues in clinical trials: the what, why, when and how. Int J Epidemiol. 2017;46(2):746–55. 2. Schulz KF, Grimes DA ...

ich harmonised tripartite guideline statistical principles for clinical ...

In some cases only an open-label trial is practically or ethically possible. Single-blind and open-label trials provide additional flexibility, but it is ...

FDA explains how to use secondary endpoints in clinical trials to ...

However, even in cases where a multiplicity adjustment is not required, the introduction ... multiple endpoints is a valuable clinical trial ...

Submission of comments form - Efpia

... multiplicity issues in clinical trials that are currently not covered in the draft guidance. Possible topics include: Endpoint analysis ...

Non-adjustment for multiple testing in multi-arm trials of distinct ...

in our clinical efficacy conclusion, which we invariably ... An intro- duction to multiplicity issues in clinical trials: the what, why, when and how.