TY - JOUR
T1 - Methodologic considerations in randomized clinical trials in reproductive medicine
AU - Venetis, Christos
AU - d'Hooghe, Thomas
AU - Barnhart, Kurt T.
AU - Bossuyt, Patrick M. M.
AU - Mol, Ben Willem J.
PY - 2020/6/1
Y1 - 2020/6/1
N2 - 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.
AB - 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.
KW - Randomized clinical trial
KW - bayesian analysis
KW - big data
KW - frequentist approach
KW - methodology
KW - personalized medicine
UR - http://www.scopus.com/inward/record.url?scp=85085526622&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.fertnstert.2020.04.038
DO - https://doi.org/10.1016/j.fertnstert.2020.04.038
M3 - Review article
C2 - 32482246
SN - 0015-0282
VL - 113
SP - 1107
EP - 1112
JO - Fertility and Sterility
JF - Fertility and Sterility
IS - 6
ER -