Literature DB >> 22318615

The prevention and treatment of missing data in clinical trials: an FDA perspective on the importance of dealing with it.

R T O'Neill1, R Temple.   

Abstract

At the request of the Food and Drug Administration (FDA) and with its funding, the Panel on the Handling of Missing Data in Clinical Trials was created by the National Research Council's Committee on National Statistics. This panel recently published a report(1) with recommendations that will be of use not only to the FDA but also to the entire clinical trial community so that the latter can take measures to improve the conduct and analysis of clinical trials.

Mesh:

Year:  2012        PMID: 22318615     DOI: 10.1038/clpt.2011.340

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


  35 in total

Review 1.  Reporting of Design Features and Analysis Details in Randomized Clinical Trials of Procedural Treatments for Cancer Pain: An ACTTION Systematic Review.

Authors:  Daniel Rothstein; Rachel A Kitt; Shannon M Smith; Salahadin Abdi; Mitchell P Engle; Michael P McDermott; Srinivasa N Raja; Dennis C Turk; Robert H Dworkin; Jennifer S Gewandter
Journal:  Reg Anesth Pain Med       Date:  2017 May/Jun       Impact factor: 6.288

2.  Handling missing data in a duloxetine population pharmacokinetic/pharmacodynamic model - imputation methods and selection models.

Authors:  Eunice Yuen; Ivelina Gueorguieva; Leon Aarons
Journal:  Pharm Res       Date:  2014-05-03       Impact factor: 4.200

3.  New polymorphisms associated with response to anti-TNF drugs in patients with moderate-to-severe plaque psoriasis.

Authors:  R Prieto-Pérez; G Solano-López; T Cabaleiro; M Román; D Ochoa; M Talegón; O Baniandrés; J L López-Estebaranz; P de la Cueva; E Daudén; F Abad-Santos
Journal:  Pharmacogenomics J       Date:  2016-09-27       Impact factor: 3.550

4.  A novel complete-case analysis to determine statistical significance between treatments in an intention-to-treat population of randomized clinical trials involving missing data.

Authors:  Wei Liu; Jinhui Ding
Journal:  Stat Methods Med Res       Date:  2016-05-25       Impact factor: 3.021

5.  Missing data frequency and correlates in two randomized surgical trials for urinary incontinence in women.

Authors:  Linda Brubaker; Heather J Litman; Hae-Young Kim; Philippe Zimmern; Keisha Dyer; John W Kusek; Holly E Richter; Anne Stoddard
Journal:  Int Urogynecol J       Date:  2015-03-24       Impact factor: 2.894

6.  Use of research electronic data capture (REDCap) in a COVID-19 randomized controlled trial: a practical example.

Authors:  Sina Kianersi; Maya Luetke; Christina Ludema; Alexander Valenzuela; Molly Rosenberg
Journal:  BMC Med Res Methodol       Date:  2021-08-21       Impact factor: 4.615

7.  The prevention and treatment of missing data in clinical trials.

Authors:  Roderick J Little; Ralph D'Agostino; Michael L Cohen; Kay Dickersin; Scott S Emerson; John T Farrar; Constantine Frangakis; Joseph W Hogan; Geert Molenberghs; Susan A Murphy; James D Neaton; Andrea Rotnitzky; Daniel Scharfstein; Weichung J Shih; Jay P Siegel; Hal Stern
Journal:  N Engl J Med       Date:  2012-10-04       Impact factor: 91.245

8.  Fallacies of last observation carried forward analyses.

Authors:  John M Lachin
Journal:  Clin Trials       Date:  2015-09-22       Impact factor: 2.486

Review 9.  Statistical issues and methods in designing and analyzing survival studies.

Authors:  Muditha Perera; Alok Kumar Dwivedi
Journal:  Cancer Rep (Hoboken)       Date:  2019-05-09

10.  Meta-analysis of Placebo Response in Randomized Clinical Trials of Antipsychotic Drugs Using PANSS Focusing on Different Approaches to the Handling of Missing Data.

Authors:  Akiko Matsusaki; Masayuki Kaneko; Mamoru Narukawa
Journal:  Clin Drug Investig       Date:  2018-08       Impact factor: 2.859

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