We describe the use of multiple endpoints in the design, analysis, and interpretation of pain clinical trials, and review available strategies and methods for addressing multiplicity.
One of the major challenges for scientists and clinical researchers is to define new surrogate endpoints adapted to anti-angiogenic agents in the design of clinical trials.
Herein, we explored dosing and virological endpoints to guide the design of human trials of VIS513, a pan-serotype anti-DENV IgG1 antibody, in non-human primates (NHPs).
PVR participated in the design of the study (neonatal endpoints).
HV participated in the design of the study (obstetrical endpoints).
JMF participated in the design of the study (obstetrical endpoints).
Guidance or consultation of a statistician should be enlisted in the design of the study once the endpoint variability has been characterized.
The within-subject variability, crucial in the design of trials with FMD as an endpoint, appears to vary widely between studies.
A limitation in the design of this study was its reliance on hospitalization events as the endpoint of interest.
