Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation.
Journal
Clinical pharmacology and therapeutics
ISSN: 1532-6535
Titre abrégé: Clin Pharmacol Ther
Pays: United States
ID NLM: 0372741
Informations de publication
Date de publication:
04 2020
04 2020
Historique:
received:
16
07
2019
accepted:
02
09
2019
pubmed:
2
10
2019
medline:
28
10
2020
entrez:
2
10
2019
Statut:
ppublish
Résumé
Real-world data and patient-level data from completed randomized controlled trials are becoming available for secondary analysis on an unprecedented scale. A range of novel methodologies and study designs have been proposed for their analysis or combination. However, to make novel analytical methods acceptable for regulators and other decision makers will require their testing and validation in broadly the same way one would evaluate a new drug: prospectively, well-controlled, and according to a pre-agreed plan. From a European regulators' perspective, the established methods qualification advice procedure with active participation of patient groups and other decision makers is an efficient and transparent platform for the development and validation of novel study designs.
Identifiants
pubmed: 31574163
doi: 10.1002/cpt.1638
pmc: PMC7158212
doi:
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
773-779Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
© 2019 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.
Références
Stat Methods Med Res. 2018 Jan;27(1):142-157
pubmed: 26988928
Am J Med. 1982 Feb;72(2):233-40
pubmed: 7058834
Br J Clin Pharmacol. 2019 Apr;85(4):659-668
pubmed: 30707770
Clin Pharmacol Ther. 2016 Dec;100(6):699-712
pubmed: 27650716
BMJ. 2018 Dec 10;363:k4245
pubmed: 30530757
Res Synth Methods. 2018 Jun;9(2):148-162
pubmed: 29073336
J Clin Epidemiol. 2006 Aug;59(8):819-28
pubmed: 16828675
Clin Pharmacol Ther. 2019 Jul;106(1):87-90
pubmed: 31112289
Clin Pharmacol Ther. 2019 Jul;106(1):33-35
pubmed: 30883700
Clin Pharmacol Ther. 2019 Jul;106(1):28-30
pubmed: 30958565
Clin Pharmacol Ther. 2019 Jul;106(1):43-44
pubmed: 30942896
Clin Pharmacol Ther. 2017 Dec;102(6):924-933
pubmed: 28836267
Clin Pharmacol Ther. 2019 Apr;105(4):912-922
pubmed: 30178490
Pharmacoepidemiol Drug Saf. 2018 Mar;27(3):245-252
pubmed: 29327451
Clin Pharmacol Ther. 2019 Jul;106(1):10-18
pubmed: 31273768
Biom J. 2015 Jan;57(1):8-26
pubmed: 24942505
Clin Pharmacol Ther. 2019 Apr;105(4):867-877
pubmed: 30636285
PLoS One. 2018 Oct 18;13(10):e0205971
pubmed: 30335831
JAMA. 1995 Feb 1;273(5):408-12
pubmed: 7823387
J Clin Epidemiol. 2013 Aug;66(8):812-6
pubmed: 23810022
Pharm Stat. 2014 Jan-Feb;13(1):41-54
pubmed: 23913901
Nat Rev Drug Discov. 2014 May;13(5):317-8
pubmed: 24781535
Clin Pharmacol Ther. 2019 Jul;106(1):36-39
pubmed: 30970161
Biometrics. 2014 Dec;70(4):1023-32
pubmed: 25355546