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Negative post-marketing trials: often ignored

 Outlook  Accelerated or conditional marketing authorisation pathways are designed to speed up patient access to potential therapeutic advances. But when post­-marketing trials conducted to evaluate these drugs using clinical endpoints do not confirm the pre-authorisation trial results obtained using surrogate endpoints, drug regulatory agencies and the organisations responsible for cancer guidelines rarely take these negative results into account.
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©Prescrire 1 December 2023

Source: "Negative post-marketing trials: often ignored" Prescrire Int 2023; 32 (254): 304-305. Subscribers only.

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"Post-marketing studies
following conditional
authorisation: often lacking"
Prescrire Int 2023;
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"Conditional marketing
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Prescrire Int 2023;
32 (251): 223.

"Early and compassionate
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Prescrire Int 2023;
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