When to randomize patients in a randomized controlled trial?

Sarah Lensen; Matthew R Sydes; Alex Polyakov; Jack Wilkinson

doi:10.1016/j.fertnstert.2024.03.008

When to randomize patients in a randomized controlled trial?

Fertil Steril. 2024 Jun;121(6):902-904. doi: 10.1016/j.fertnstert.2024.03.008. Epub 2024 Mar 15.

Authors

Sarah Lensen¹, Matthew R Sydes², Alex Polyakov³, Jack Wilkinson⁴

Affiliations

¹ Department of Obstetrics, Gynaecology and Newborn Health, Royal Women's Hospital, University of Melbourne, Melbourne, Victoria, Australia. Electronic address: [email protected].
² Medical Research Council Clinical Trials Unit, University College London, London, United Kingdom.
³ Department of Obstetrics, Gynaecology and Newborn Health, Royal Women's Hospital, University of Melbourne, Melbourne, Victoria, Australia; Reproductive Biology Unit, Royal Women's Hospital, Melbourne, Victoria, Australia.
⁴ Centre for Biostatistics, The University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.

PMID: 38494103
DOI: 10.1016/j.fertnstert.2024.03.008

Abstract

The timing of randomization should be considered carefully in the context of each trial because it has implications for the particular research question answered. In most instances, randomization should be delayed until as close as practically possible to the moment of intervention. In some cases, early randomization may offer certain advantages, but trialists should balance these, including any administrative complexity or inconvenience, against the risk of avoidable protocol violations and avoidable drop out.

Keywords: RCT; Randomization; methodology.

Publication types

Review

MeSH terms

Female
Humans
Patient Selection
Randomized Controlled Trials as Topic* / methods
Research Design
Time Factors