The Evolution of Adaptiveness: Balancing Speed and Evidence

Overview

Journal Nat Rev Drug Discov

Specialty Pharmacology

Date 2018 Jul 7

PMID 29977052

Citations 4

Authors

Hans-Georg Eichler

Richard Barker

Nicola Bedlington

Jacoline C Bouvy

Andre W Broekmans

Anna Bucsics

Francesca Cerreta

Solange Corriol-Rohou

Alicia Granados

Yann Le Cam

Ad Schuurman

Affiliations

Soon will be listed here.

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References

Eichler H, Oye K, Baird L, Abadie E, Brown J, Drum C . Adaptive licensing: taking the next step in the evolution of drug approval. Clin Pharmacol Ther. 2012; 91(3):426-37. DOI: 10.1038/clpt.2011.345. View

Djulbegovic B, Glasziou P, Klocksieben F, Reljic T, VanDenBergh M, Mhaskar R . Larger effect sizes in nonrandomized studies are associated with higher rates of EMA licensing approval. J Clin Epidemiol. 2018; 98:24-32. DOI: 10.1016/j.jclinepi.2018.01.011. View

Bouvy J, Sapede C, Garner S . Managed Entry Agreements for Pharmaceuticals in the Context of Adaptive Pathways in Europe. Front Pharmacol. 2018; 9:280. PMC: 5881456. DOI: 10.3389/fphar.2018.00280. View