Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…
COMMENTARY
Data from Humanitarian Trials to Be Used in Product Reviews; Effective Use of Safety-Related Information Will Be Key
A basic plan for so-called “humanitarian trials,” or a Japanese version of the compassionate use system, was announced in September. The plan would permit expanded access to new drugs following domestic “main studies,” or during such studies (after patient enrollment…
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COMMENTARY
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