Références

     

[1] U.S. Department of Health, Human Services - Food, Drug Administration. Adaptive Designs for Clinical Trials of Drugs and Biologics - Guidance for Industry 2019 ;

[2] Bhatt DL, Mehta C, Drazen JM, et al. Adaptive Designs for Clinical Trials. New Engl J Med 2016;375:65–74 10.1056/NEJMra1510061

[3] Porcher R, Lecocq B, Vray M, et al. Les méthodes adaptatives quand et comment les utiliser dans les essais cliniques ? Thérapie 2011;66:309–17 10.2515/therapie/2011042

[4] Lachin JM. A review of methods for futility stopping based on conditional power. Stat Med 2005;24:2747–64 10.1002/sim.2151

[5] Thall P, Fox P, Wathen J. Statistical controversies in clinical research: scientific and ethical problems with adaptive randomization in comparative clinical trials. Annals of Oncology 2015;26:1621–28 10.1093/annonc/mdv238

[6] McMurray JJV, Packer M, Desai AS, et al. Angiotensin–Neprilysin Inhibition versus Enalapril in Heart Failure. New Engl J Med 2014 10.1056/NEJMoa1409077

[7] McMurray JJV, Ostergren J, Swedberg K, et al. Effects of candesartan in patients with chronic heart failure and reduced left-ventricular systolic function taking angiotensin-converting-enzyme inhibitors: the CHARM-Added trial. The Lancet 2003;362:767–71 10.1016/S0140-6736(03)14283-3 [13678869]

[8] Boulware DR, Pullen MF, Bangdiwala AS, et al. A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19. New Engl J Med 2020 10.1056/NEJMoa2016638

[9] van Eijk RPA, Nikolakopoulos S, Ferguson TA, et al. Increasing the efficiency of clinical trials in neurodegenerative disorders using group sequential trial designs. Journal of Clinical Epidemiology 2018;98:80–88 10.1016/j.jclinepi.2018.02.013

[10] Wilson N, Biggs K, Bowden S, et al. Costs and staffing resource requirements for adaptive clinical trials: quantitative and qualitative results from the Costing Adaptive Trials project. BMC Med 2021;19:1–17 10.1186/s12916-021-02124-z