Good Clinical Practice Guidance and Pragmatic Clinical Trials: Balancing the Best of Both Worlds.
Mentz, Robert J; Hernandez, Adrian F; Berdan, Lisa G; Rorick, Tyrus; O'Brien, Emily C; Ibarra, Jenny C; Curtis, Lesley H; Peterson, Eric D.
; 133(9): 872-80, 2016 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-26927005
Criteria for the use of omics-based predictors in clinical trials.
2015 Guidance on cancer immunotherapy development in early-phase clinical studies.
A tutorial on sensitivity analyses in clinical trials: the what, why, when and how.
Opening clinical trial data: are the voluntary data-sharing portals enough?
Criteria for the use of omics-based predictors in clinical trials: explanation and elaboration.
Do commonly used clinical trial designs reflect clinical reality?
An adaptive two-stage dose-response design method for establishing proof of concept.
Strategies for dealing with missing data in clinical trials: from design to analysis.
Harms, benefits, and the nature of interventions in pragmatic clinical trials.
Comparison of serious adverse events posted at ClinicalTrials.gov and published in corresponding journal articles.