Training New DMC Members: A Call to Action

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 i...

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Vydáno v:Therapeutic innovation & regulatory science Ročník 58; číslo 2; s. 234 - 235
Hlavní autoři: Rockhold, Frank, Mahaffey, Kenneth, DeMets, David
Médium: Journal Article
Jazyk:angličtina
Vydáno: Cham Springer International Publishing 01.03.2024
Springer Nature B.V
Témata:
Clinical trials
Clinical Trials Data Monitoring Committees
Commentary
Committees
Confidentiality
Conflicts of interest
Data science
Drug Safety and Pharmacovigilance
Ethics
Human subjects
Humans
Industry
Inservice Training
Medicine
Mentoring
Pharmacotherapy
Pharmacy
Training
Data Monitoring Committees
Training, Mentoring
Mentoring
Apprentice
ISSN:2168-4790, 2168-4804, 2168-4804
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Shrnutí: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”.
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ISSN:2168-4790
2168-4804
2168-4804
DOI:10.1007/s43441-023-00580-8