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The evolution of adaptiveness: balancing speed and evidence

'Adaptive' approaches to bringing drugs to market have been widely discussed in recent years. Here, we describe the evolution of the adaptive approach and of concepts developed by ADAPT SMART, a multi-stakeholder consortium funded by the European Innovative Medicines Initiative.

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References

  1. Eichler, H.-G. et al. Adaptive licensing: taking the next step in the evolution of drug approval. Clin. Pharmacol. Ther. 91, 426–437 (2012).

    Article  Google Scholar 

  2. Djulbegovic, B. et al. Larger effect sizes in non-randomized studies are associated with higher rates of EMA licensing approval. J. Clin. Epidemiol. 98, 24–32 (2018)10.1016/j.jclinepi.2018.01.011.

    Article  PubMed  Google Scholar 

  3. Bouvy, J. C. et al. Managed entry for pharmaceuticals in the context of adaptive pathways in Europe. Front. Pharmacol. 9, 280 (2018)10.3389/fphar.2018.00280.

    Article  PubMed  PubMed Central  Google Scholar 

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Acknowledgements

The views in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the agencies or organizations with which the authors are affiliated.

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Correspondence to Hans-Georg Eichler.

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Richard Barker is a non-executive director of Image Analysis Group, Kvatchii and Celgene. Solange Corriol-Rohou is an employee of AstraZeneca. Alicia Granados is an employee of Sanofi.

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Eichler, HG., Barker, R., Bedlington, N. et al. The evolution of adaptiveness: balancing speed and evidence. Nat Rev Drug Discov 17, 845–846 (2018). https://doi.org/10.1038/nrd.2018.90

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