In this review, the authors consider the characteristics and challenges of noninferiority trial designs, including seven essential features of noninferiority trials.

Background: Dose-finding trials are essential to drug development as they establish recommended doses for later-phase testing. We aim to motivate wider use of model-based designs for dose finding ...

Invivyd (IVVD) announced that the SPEAR Study Group has issued their consensus recommendation for a clinical study design to evaluate the effects of monoclonal antibody, mAb, therapy on Long COVID.

The test-negative design has been routinely used to estimate vaccine effectiveness against seasonal influenza, 5 but its application in studies of Covid-19, although increasingly common, is new.

“The use of IRSF’s Natural History Study data to support the NGN-401 gene therapy registrational trial design is a powerful example of how families accelerate and streamline therapeutic ...

Vivian C. Wong, Peter M. Steiner, Thomas D. Cook, Analyzing Regression-Discontinuity Designs With Multiple Assignment Variables: A Comparative Study of Four Estimation Methods, Journal of Educational ...