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Training New DMC Members: A Call to Action.

Publication ,  Journal Article
Rockhold, F; Mahaffey, K; DeMets, D
Published in: Ther Innov Regul Sci
March 2024

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".

Duke Scholars

Published In

Ther Innov Regul Sci

DOI

EISSN

2168-4804

Publication Date

March 2024

Volume

58

Issue

2

Start / End Page

234 / 235

Location

Switzerland

Related Subject Headings

  • Statistics & Probability
  • Mentoring
  • Inservice Training
  • Industry
  • Humans
  • Clinical Trials Data Monitoring Committees
  • 4905 Statistics
  • 3214 Pharmacology and pharmaceutical sciences
  • 1117 Public Health and Health Services
  • 0104 Statistics
 

Citation

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Rockhold, F., Mahaffey, K., & DeMets, D. (2024). Training New DMC Members: A Call to Action. Ther Innov Regul Sci, 58(2), 234–235. https://doi.org/10.1007/s43441-023-00580-8
Rockhold, Frank, Kenneth Mahaffey, and David DeMets. “Training New DMC Members: A Call to Action.Ther Innov Regul Sci 58, no. 2 (March 2024): 234–35. https://doi.org/10.1007/s43441-023-00580-8.
Rockhold F, Mahaffey K, DeMets D. Training New DMC Members: A Call to Action. Ther Innov Regul Sci. 2024 Mar;58(2):234–5.
Rockhold, Frank, et al. “Training New DMC Members: A Call to Action.Ther Innov Regul Sci, vol. 58, no. 2, Mar. 2024, pp. 234–35. Pubmed, doi:10.1007/s43441-023-00580-8.
Rockhold F, Mahaffey K, DeMets D. Training New DMC Members: A Call to Action. Ther Innov Regul Sci. 2024 Mar;58(2):234–235.
Journal cover image

Published In

Ther Innov Regul Sci

DOI

EISSN

2168-4804

Publication Date

March 2024

Volume

58

Issue

2

Start / End Page

234 / 235

Location

Switzerland

Related Subject Headings

  • Statistics & Probability
  • Mentoring
  • Inservice Training
  • Industry
  • Humans
  • Clinical Trials Data Monitoring Committees
  • 4905 Statistics
  • 3214 Pharmacology and pharmaceutical sciences
  • 1117 Public Health and Health Services
  • 0104 Statistics