The SHIVA trial compared the efficacy of targeted agents selected on the basis of tumour molecular profiling (using an algorithmic approach) with that of physician's choice across multiple solid tumours; the trial was negative for the primary end point. We now discuss the challenges associated with precision medicine trial design and propose solutions learned from this trial.
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Acknowledgements
This work was partially supported by the Joan and Irwin Jacobs Fund. The SHIVA trial was supported by the grant ANR-10-EQPX-03 from the Agence Nationale de le Recherche (Investissements d'avenir) and SiRIC (Site de Recherche Intégré contre le Cancer).
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C.L.T. has received consultant fees from Debiopharm, GamaMabs, Merck Serono, MSD and Novartis. R.K. receives funding from Foundation Medicine, Genentech, Guardant, Merck Serono, Pfizer and Sequenom, consultant fees from Actuate Therapeutics and X-Biotech, and owns equity in CureMatch and Novena.
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Le Tourneau, C., Kurzrock, R. What have we learned from SHIVA?. Nat Rev Clin Oncol 13, 719–720 (2016). https://doi.org/10.1038/nrclinonc.2016.164
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DOI: https://doi.org/10.1038/nrclinonc.2016.164
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