Time as an outcome measure in fertility-related clinical studies: long-awaited.
clinical trial design
endpoints
medically assisted reproduction
outcomes
statistical study design
study design
time
time to live birth
trial design
Journal
Human reproduction (Oxford, England)
ISSN: 1460-2350
Titre abrégé: Hum Reprod
Pays: England
ID NLM: 8701199
Informations de publication
Date de publication:
01 08 2020
01 08 2020
Historique:
received:
30
10
2019
revised:
27
04
2020
pubmed:
10
7
2020
medline:
28
4
2021
entrez:
10
7
2020
Statut:
ppublish
Résumé
Time taken to achieve a live birth is an important consideration that is central to managing patient expectations during infertility treatment. However, time-related endpoints are not reported as standard in the majority of fertility-related clinical studies and there is no internationally recognized consensus definition for such endpoints. There is, therefore, a need for meaningful discussions around the selection of appropriate time-related treatment outcome measures for studies evaluating fertility treatments that will be relevant to diverse stakeholders (e.g. patients, healthcare professionals, clinical scientists, authorities and industry). Here, we provide a proposal for the evaluation of time-related outcome measures in fertility-related clinical studies, alongside associated definitions.
Identifiants
pubmed: 32644107
pii: 5869372
doi: 10.1093/humrep/deaa138
pmc: PMC7398622
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1732-1739Informations de copyright
© The Author(s) 2020. Published by Oxford University Press on behalf of European Society of Human Reproduction and Embryology.
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