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Posted On: 10/03/2023 7:01:39 PM
Post# of 155865
Hey Drano. You are correct, and AI will only AUGMENT the trial process, not replace it. This is taken from a Reuters article:
Gen Li, founder of clinical data analytics firm Phesi, said many companies were exploring AI's potential to reduce the need for control groups.
Regulators, however, say that although AI has the potential to augment the clinical trial process, evidentiary standards for a drug's safety and effectiveness will not change.
"The main risks with AI are that we want to make sure we don't get the wrong answer to the question of whether a drug works," said John Concato, associate director for real-world evidence analytics in the Office of Medical Policy in the FDA's Center for Drug Evaluation and Research.
Gen Li, founder of clinical data analytics firm Phesi, said many companies were exploring AI's potential to reduce the need for control groups.
Regulators, however, say that although AI has the potential to augment the clinical trial process, evidentiary standards for a drug's safety and effectiveness will not change.
"The main risks with AI are that we want to make sure we don't get the wrong answer to the question of whether a drug works," said John Concato, associate director for real-world evidence analytics in the Office of Medical Policy in the FDA's Center for Drug Evaluation and Research.
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