JAMA Neurol, Jun 17

Challenges to Translation and the Hippocratic Oath by Premature Termination of Spinal Cord Stem Cell-Based Trials.


Curt A, Levi AD, Schwab JM

 

Untimely termination of clinical trials owing to strategic corporate considerations (30%)1 or futility analysis (50%)1 account for most prematurely discontinued studies, and spinal cord injury (SCI) trials are no exception (Figure).2 In this commentary, we advocate for clear termination rules, including an orderly exit plan, as a prerequisite for regulatory approval to optimize safe and effective clinical translation. Invasive cell transplant trials in SCI require excellent preclinical and clinical safety and efficacy data, pioneering spirit, and intensive resource investment. However, premature termination without an orderly exit plan produces harmful consequences worthy of discussion.

 

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