Methodologic considerations in randomized clinical trials in reproductive medicine

Christos Venetis; Thomas d'Hooghe; Kurt T. Barnhart; Patrick M.M. Bossuyt; Ben Willem J. Mol

doi:10.1016/j.fertnstert.2020.04.038

Methodologic considerations in randomized clinical trials in reproductive medicine

Christos Venetis, Thomas d'Hooghe, Kurt T. Barnhart, Patrick M.M. Bossuyt, Ben Willem J. Mol^*

^*Corresponding author for this work

Research output: Contribution to journal › Review article › peer-review

4 Citations (Scopus)

Abstract

Randomized controlled trials (RCTs) are the cornerstone of evidence-based medicine. In this series in Fertility and Sterility, several aspects of RCTs are discussed, with contributions on multicenter RCTs, different international settings, and integrity of RCTs. The present contribution deals with methodologic issues. We discuss different types of RCTs based on null hypothesis (superiority vs. noninferiority vs. equivalence) as well as frequentist versus Bayesian interpretation. We also discuss the use of RCTs in the era of personalized medicine and RCTs to address diagnostic and prognostic questions. Finally, we address the use of big data compared with the use of RCTs.

Original language	English
Pages (from-to)	1107-1112
Number of pages	6
Journal	Fertility and Sterility
Volume	113
Issue number	6
Early online date	30 May 2020
DOIs	https://doi.org/10.1016/j.fertnstert.2020.04.038
Publication status	Published - Jun 2020

Bibliographical note

Keywords

bayesian analysis
big data
frequentist approach
methodology
personalized medicine
Randomized clinical trial
DESIGN
PROGESTERONE
MODEL
PREDICTION
BAYESIAN METHODS
WOMEN
BIG DATA
TECHNOLOGY

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title = "Methodologic considerations in randomized clinical trials in reproductive medicine",

abstract = "Randomized controlled trials (RCTs) are the cornerstone of evidence-based medicine. In this series in Fertility and Sterility, several aspects of RCTs are discussed, with contributions on multicenter RCTs, different international settings, and integrity of RCTs. The present contribution deals with methodologic issues. We discuss different types of RCTs based on null hypothesis (superiority vs. noninferiority vs. equivalence) as well as frequentist versus Bayesian interpretation. We also discuss the use of RCTs in the era of personalized medicine and RCTs to address diagnostic and prognostic questions. Finally, we address the use of big data compared with the use of RCTs.",

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doi = "10.1016/j.fertnstert.2020.04.038",

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AU - Bossuyt, Patrick M.M.

AU - Mol, Ben Willem J.

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KW - bayesian analysis

KW - big data

KW - frequentist approach

KW - methodology

KW - personalized medicine

KW - Randomized clinical trial

KW - DESIGN

KW - PROGESTERONE

KW - MODEL

KW - PREDICTION

KW - BAYESIAN METHODS

KW - WOMEN

KW - BIG DATA

KW - TECHNOLOGY

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Methodologic considerations in randomized clinical trials in reproductive medicine

Abstract

Bibliographical note

Keywords

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