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Editorial
. 2020 Jul;73(1):9-11.
doi: 10.1016/j.jhep.2020.04.034. Epub 2020 Apr 30.

STELLAR 3 and STELLAR 4: Lessons from the fall of Icarus

Mary E Rinella  1 , Mazen Noureddin  2
Affiliations
Editorial

STELLAR 3 and STELLAR 4: Lessons from the fall of Icarus

Mary E Rinella et al. J Hepatol. 2020 Jul.
No abstract available

Keywords: Fibrosis; NASH; Phase 2 trails; Phase 3 trials; Selonserib.

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Conflict of interest statement

Conflict of interest Mary E. Rinella, MD: Consulting: Intercept Pharmaceuticals, Gilead Sciences, NGM Biopharmaceuticals, Enanta, Immuron, Fractyl, Prociento, Gelesis, Merck, Bristol-Myers Squibb, Metacrine, Viking Therapeutics, Allergan, Cymabay, Boehringer Ingelheim, Genentech, Sagimet Bio, Terns, Siemens and Novartis. Independent research grant funding from Novartis. Support in kind from Owl. Mazen Noureddin, MD; MHSc: MN has been on the advisory board for Gilead, Intercept, Pfizer, Novartis, Allergan, Blade, EchoSens North America, OWL, Terns, Simenes, Zydus, and Abbott; MN has received research support from Allergan, BMS, Gilead, Galmed, Galectin, Genfit, Conatus, Enanta, Novartis, Shire and Zydus; MN is a minor shareholder or has stocks in Anaetos and Viking. Please refer to the accompanying ICMJE disclosure forms for further details.

Figures

Fig. 1
Fig. 1
Mitigating risk of failure in phase III. Various elements culminating in the design and execution of a phase III trial can heavily influence the probability of success. Each of these aspects, depicted by colored circles, are associated with varying degrees of difficulty, measured by cost, time and scale. Each also differentially contributes to the predictivity of success in a phase III program. While one can never be certain that the primary endpoint will be met, the more of these critical elements are satisfied, the more predictable an outcome will be (multicolored circle). PBO, placebo; RCT, randomized controlled trial.
None
Landscape with the Fall of Icarus by Pieter Bruegel the Elder.
See this image and copyright information in PMC

Comment on

References

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