Incorporating and interpreting regulatory guidance on estimands in diabetes clinical trials: The PIONEER 1 randomized clinical trial as an example-Reference-Cited by-同舟云学术

Incorporating and interpreting regulatory guidance on estimands in diabetes clinical trials: The PIONEER 1 randomized clinical trial as an example

Published:2019-06-30 Issue:10 Volume:21 Page:2203-2210
ISSN:1462-8902
Container-title:Diabetes, Obesity and Metabolism
language:en
Short-container-title:Diabetes Obes Metab

Author:

Aroda Vanita R.¹^ORCID,Saugstrup Trine²,Buse John B.³,Donsmark Morten²,Zacho Jeppe²,Davies Melanie J.⁴^ORCID

Affiliation:

1. Department of Medicine, Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's HospitalHarvard Medical School Boston Massachusetts

2. Novo Nordisk A/S Søborg Denmark

3. Department of Medicine, Division of Endocrinology and Metabolism, Diabetes Care CenterUniversity of North Carolina School of Medicine Chapel Hill North Carolina

4. Department of Health Sciences, Diabetes Research CentreUniversity of Leicester Leicester UK

Publisher

Wiley

Subject

Endocrinology,Endocrinology, Diabetes and Metabolism,Internal Medicine

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/dom.13804

Reference24 articles.

1. US Food and Drug Administration. Guidance for industry. Diabetes mellitus: developing drugs and therapeutic biologics for treatment and prevention 2008.https://wwwfdagov/downloads/Drugs//Guidances/ucm071624pdf. Accessed April 2 2019.

2. Choice of estimand and analysis methods in diabetes trials with rescue medication

3. Missing data in clinical trials: control-based mean imputation and sensitivity analysis

4. International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use. ICH Concept Paper E9 (R1): Addendum to Statistical Principles for Clinical Trials on Choosing Appropriate Estimands and Defining Sensitivity Analyses in Clinical Trials 2014.http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/E9__R1__Final_Concept_Paper_October_23_2014.pdf. Accessed December 17 2018.

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