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
Blinded versus unblinded estimation of a correlation coefficient to inform interim design adaptations.
An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials.
Choice of futility boundaries for group sequential designs with two endpoints.
Differences in methodological quality between positive and negative published clinical trials.
Clinical Trial Feasibility Study Questionnaire Analysis.
Efficient confidence limits for adaptive one-arm two-stage clinical trials with binary endpoints.
Criteria for the use of omics-based predictors in clinical trials.
Use of Placebo in Pediatric Inflammatory Bowel Diseases: A Position Paper From ESPGHAN, ECCO, PIBDnet, and the Canadian Children IBD Network.
Restrictive and liberal red cell transfusion strategies in adult patients: reconciling clinical data with best practice.
Clinical trial design in the neurocritical care unit.