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STELLAR 3 and STELLAR 4: Lessons From the Fall of Icarus

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STELLAR 3 and STELLAR 4: Lessons From the Fall of Icarus

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When planes crash or experience a near miss, the United States Federal Aviation Authority has a longstanding policy that mandates a review that “will ensure that all of the facts, conditions, and circumstances leading to an event are recorded and evaluated, and that action is taken to prevent similar events to the extent practical and feasible.” Safety and efficacy of air travel is immeasurably better for it.

Development pathways for pharmacological therapeutic agents are long and fraught with unpredictable expense and outcome. We are, as a society, fortunate that there are individuals and organizations with the skills, knowledge and resources needed to achieve the spectacular advances in the diagnosis and treatment of many diseases, such as the advent of direct acting antiviral agents for hepatitis C or checkpoint inhibitors for a host of neoplasia. COVID-19 will, hopefully, soon be added to the list of tamed scourges. For medicine to advance at the pace and cost we desire, it is important, however, to give as much consideration to the facts, conditions, and circumstances that lead to failed phase 3 studies as we do to successes.

There can be few more pertinent examples of this than the growing number of advanced (pivotal phase 2 or 3) clinical trials in NASH that have failed or nearly failed to meet their primary endpoint(s).[

  • Garcia-Tsao G.
  • Bosch J.
  • Kayali Z.
  • Harrison S.A.
  • Abdelmalek M.F.
  • Lawitz E.
  • et al.
Randomized placebo-controlled trial of emricasan for non-alcoholic steatohepatitis-related cirrhosis with severe portal hypertension.