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Intensive care medicine in 2050: clinical trials designs

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References

  1. Aberegg SK, Richards DR, O’Brien JM (2010) Delta inflation: a bias in the design of randomized controlled trials in critical care medicine. Crit Care 14:R77. https://doi.org/10.1186/cc8990

    Article  PubMed  PubMed Central  Google Scholar 

  2. Porcher R, Lévy V, Chevret S (2002) Sample size correction for treatment crossovers in randomized clinical trials with a survival endpoint. Control Clin Trials 23(6):650–661

    Article  PubMed  Google Scholar 

  3. Alsop J, Scott M, Archey W (2016) The mixed randomized trial: combining randomized, pragmatic and observational clinical trial designs. J Comp Eff Res 5(6):569–579. https://doi.org/10.2217/cer-2016-0034

    Article  PubMed  Google Scholar 

  4. Maslove DM, Lamontagne F, Marshall JC, Heyland DK (2017) A path to precision in the ICU. Crit Care 21:79. https://doi.org/10.1186/s13054-017-1653-x

    Article  PubMed  PubMed Central  Google Scholar 

  5. Renfro LA, An MW, Mandrekar SJ (2017) Precision oncology: a new era of cancer clinical trials. Cancer Lett 387:121–126. https://doi.org/10.1016/j.canlet.2016.03.015

    Article  CAS  PubMed  Google Scholar 

  6. Kelloff GJ, Sigman CC (2012) Cancer biomarkers: selecting the right drug for the right patient. Nat Rev Drug Discov 11(3):201–214

    Article  CAS  PubMed  Google Scholar 

  7. Bhatt DL, Mehta C (2016) Adaptive designs for clinical trials. N Engl J Med 375(1):65–74. https://doi.org/10.1056/nejmra1510061

    Article  PubMed  Google Scholar 

  8. Pallmann P, Bedding AW, Choodari-Oskooei B, Dimairo M, Flight L, Hampson LV, Holmes J, Mander AP, Odondi L, Sydes MR, Villar SS, Wason JMS, Weir CJ, Wheeler GM, Yap C, Jaki T (2018) Adaptive designs in clinical trials: why use them, and how to run and report them. BMC Med 16(1):29. https://doi.org/10.1186/s12916-018-1017-7

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  9. Thorlund K, Haggstrom J, Park JJH, Mills EJ (2018) Key design considerations for adaptive clinical trials: a primer for clinicians. BMJ 360:k698. https://doi.org/10.1136/bmj.k698

    Article  PubMed  PubMed Central  Google Scholar 

  10. Simon N, Simon R (2013) Adaptive enrichment designs for clinical trials. Biostatistics 14(4):613–625. https://doi.org/10.1093/biostatistics/kxt010

    Article  PubMed  PubMed Central  Google Scholar 

  11. Wong HR, Lindsell CJ (2016) An enrichment strategy for sepsis clinical trials. Shock 46(6):632–634. https://doi.org/10.1097/SHK.0000000000000693

    Article  PubMed  PubMed Central  Google Scholar 

  12. Talisa VB, Yende S, Seymour CW, Angus DC (2018) Arguing for adaptive clinical trials in sepsis. Front Immunol 9:1502. https://doi.org/10.3389/fimmu.2018.01502

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  13. Sydes MR, Parmar MK, Mason MD, Clarke NW, Amos C, Anderson J et al (2012) Flexible trial design in practice—stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial. Trials 13(1):168

    Article  PubMed  PubMed Central  Google Scholar 

  14. Thall P, Fox P, Wathen J (2015) Statistical controversies in clinical research: scientific and ethical problems with adaptive randomization in comparative clinical trials. Ann Oncol 26(8):1621–1628

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  15. Berry SM, Carlin BP, Lee JJL, Muller P (2010) Bayesian adaptive methods for clinical trials. CRC, Boca Raton

    Book  Google Scholar 

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Authors and Affiliations

  1. Department of Mathematical Sciences, Politecnico di Torino, Turin, Italy

    M. Gasparini

  2. AP-HP, Saint-Louis Hospital, Biostatistics Team, Paris, France

    S. Chevret

  3. Paris Diderot University, Inserm, ECSTRRA Team, Paris, France

    S. Chevret

Authors
  1. M. Gasparini
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  2. S. Chevret
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Correspondence to S. Chevret.

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Gasparini, M., Chevret, S. Intensive care medicine in 2050: clinical trials designs. Intensive Care Med 45, 668–670 (2019). https://doi.org/10.1007/s00134-018-5364-9

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  • DOI: https://doi.org/10.1007/s00134-018-5364-9

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