Literature DB >> 29119556

Estimands: A More Strategic Approach to Study Design and Analysis.

Mouna Akacha1, Wolfgang Kothny2.   

Abstract

Do we always precisely define the treatment effects that our clinical trial will estimate? Our tenet is that this is not always done, or is done inadequately. This lack of clarity can result in a misalignment among trial objectives, trial design, and statistical methods. We will discuss these challenges and present an improved framework using estimands that is proposed in a draft International Council for Harmonization (ICH) E9 addendum.
© 2017 American Society for Clinical Pharmacology and Therapeutics.

Entities:  

Mesh：

Year:  2017        PMID： 29119556     DOI： 10.1002/cpt.872

Source DB:  PubMed          Journal:  Clin Pharmacol Ther        ISSN： 0009-9236            Impact factor:   6.875


  7 in total

1.  The potential of the estimands framework for clinical pharmacology trials: Some discussion points.

Authors:  Arne Ring; Martin J Wolfsegger
Journal:  Br J Clin Pharmacol       Date:  2020-03-03       Impact factor: 4.335

2.  Treatment estimands in clinical trials of patients hospitalised for COVID-19: ensuring trials ask the right questions.

Authors:  Brennan C Kahan; Tim P Morris; Ian R White; Conor D Tweed; Suzie Cro; Darren Dahly; Tra My Pham; Hanif Esmail; Abdel Babiker; James R Carpenter
Journal:  BMC Med       Date:  2020-09-09       Impact factor: 8.775

Review 3.  Incorporating and interpreting regulatory guidance on estimands in diabetes clinical trials: The PIONEER 1 randomized clinical trial as an example.

Authors:  Vanita R Aroda; Trine Saugstrup; John B Buse; Morten Donsmark; Jeppe Zacho; Melanie J Davies
Journal:  Diabetes Obes Metab       Date:  2019-06-30       Impact factor: 6.577

4.  Agreement between results of meta-analyses from case reports and clinical studies, regarding efficacy and safety of idursulfase therapy in patients with mucopolysaccharidosis type II (MPS-II). A new tool for evidence-based medicine in rare diseases.

Authors:  Miguel Sampayo-Cordero; Bernat Miguel-Huguet; Almudena Pardo-Mateos; Andrea Malfettone; José Pérez-García; Antonio Llombart-Cussac; Javier Cortés; Marc Moltó-Abad; Cecilia Muñoz-Delgado; Marta Pérez-Quintana; Jordi Pérez-López
Journal:  Orphanet J Rare Dis       Date:  2019-10-21       Impact factor: 4.123

Review 5.  Functional Loss and Mortality in Randomized Clinical Trials for Amyotrophic Lateral Sclerosis: To Combine, or Not to Combine-That is the Estimand.

Authors:  Ruben P A van Eijk; Kit C B Roes; Inez de Greef-van der Sandt; Leonard H van den Berg; Ying Lu
Journal:  Clin Pharmacol Ther       Date:  2022-02-17       Impact factor: 6.903

6.  Estimators for handling COVID-19-related intercurrent events with a hypothetical strategy.

Authors:  Florian Lasch; Lorenzo Guizzaro
Journal:  Pharm Stat       Date:  2022-06-28       Impact factor: 1.234

7.  A Systematic Evaluation of Effect of Adherence Patterns on the Sample Size and Power of a Clinical Study.

Authors:  Surulivelrajan Mallayasamy; Ayyappa Chaturvedula; Terrence Blaschke; Michael J Fossler
Journal:  CPT Pharmacometrics Syst Pharmacol       Date:  2018-10-28
  7 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.