Clinical events classification (CEC) in clinical trials: Report on the current landscape and future directions — proceedings from the CEC Summit 2018

Importance: Clinical events adjudication is pivotal for generating consistent and comparable evidence in clinical trials. The methodology of event adjudication is evolving, but research is needed to develop best practices and spur innovation. Observations: A meeting of stakeholders from regulatory a...

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Bibliographic Details
Main Authors: Alexander, K.P (Author), Ali, M. (Author), Chaitman, B.R (Author), Gibson, C.M (Author), Held, C. (Author), Hicks, K.A (Author), Hlatky, M. (Author), Jones, W.S (Author), Lopes, R.D (Author), Mahaffey, K.W (Author), Mehran, R. (Author), Menon, V. (Author), Rockhold, F.W (Author), Seltzer, J. (Author), Sharma, A. (Author), Spitzer, E. (Author), Wilson, M. (Author)
Format: Article
Language:English
Published: Elsevier Inc. 2022
Online Access:View Fulltext in Publisher