Training New DMC Members: A Call to Action.
Apprentice
Data Monitoring Committees
Mentoring
Training, Mentoring
Journal
Therapeutic innovation & regulatory science
ISSN: 2168-4804
Titre abrégé: Ther Innov Regul Sci
Pays: Switzerland
ID NLM: 101597411
Informations de publication
Date de publication:
25 Sep 2023
25 Sep 2023
Historique:
received:
21
07
2023
accepted:
05
09
2023
medline:
26
9
2023
pubmed:
26
9
2023
entrez:
25
9
2023
Statut:
aheadofprint
Résumé
Historically, clinical trialists developed DMC expertise and experience with "on the job training". Clinical trialists have recognized a large and growing gap between the demand and supply of trained DMC members due in part to the huge increase in ongoing clinical trials. A critical need exists to increase the supply of DMC trained clinicians and biostatisticians. Despite a rich collection of published training material, many have recommended a mentoring process to train clinical trialists and data scientists lacking DMC experience. We propose that academic, regulatory, industry and other leaders in clinical trials support including investigators lacking DMC experience as members of a DMC so that they can be trained to learn about the DMC processes during conduct of an actual trial".
Identifiants
pubmed: 37749420
doi: 10.1007/s43441-023-00580-8
pii: 10.1007/s43441-023-00580-8
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2023. The Author(s), under exclusive licence to The Drug Information Association, Inc.
Références
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