Efficacy Evaluation in the Era of Precision Medicine: The Scope for AI

Patient stratification and the use of real-world evidence in regulatory decision-making are two key areas where algorithms are having an impact on drug development. The two are linked: increased patient stratification makes it harder to recruit patients into randomized-controlled trials, increasing...

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Autor principal: Magirr, Dominic
Formato: Capítulo de libro
Lenguaje:inglés
Publicado: IntechOpen 2020
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Acceso en línea:https://www.intechopen.com/chapters/71925
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Sumario:Patient stratification and the use of real-world evidence in regulatory decision-making are two key areas where algorithms are having an impact on drug development. The two are linked: increased patient stratification makes it harder to recruit patients into randomized-controlled trials, increasing the pressure on drug developers to find alternative sources of evidence for showing efficacy. In addition to real-world evidence, we are also seeing the emergence of more efficient ‘master protocol trials’, where multiple targeted agents can be evaluated simultaneously. In this chapter, I will review these developments and investigate the limitations for AI in terms of demonstrating the efficacy of novel targeted agents.
ISBN:978-1-78984-689-8
DOI:10.5772/intechopen.90455