Commentary on Hey and Kimmelman

Hey SP Kimmelman J . Are outcome-adaptive allocation trials ethical? Clin Trials 2015, 12: 102–106.

Freidlin B Korn EL . Monitoring for lack of benefit: a critical component of a randomized clinical trial. J Clin Oncol 2009; 27: 629–633.

Korn EL Freidlin B . Inefficacy monitoring procedures in randomized clinical trials: the need to report. Am J Bioeth 2011; 11: 2–10.

Emanuel EJ Wendler D Grady C . What makes clinical research ethical? JAMA 2000; 283: 2701–2711.

Byar DP Simon RM Friedewald WT . Randomized clinical trials—perspectives on some recent ideas. N Engl J Med 1976; 295: 74–80.

Korn EL Freidlin B . Outcome-adaptive randomization: is it useful? J Clin Oncol 2011; 29: 771–776.

Simon R Simon NR . Using randomization tests to preserve type I error with response-adaptive and covariate-adaptive randomization. Stat Probab Lett 2011; 81: 767–772.

Rubinstein LV Korn EL Freidlin B . Design issues of randomized phase II trials and a proposal for phase II screening trials. J Clin Oncol 2005; 23: 7199–7206.

Faderl S Ravandi F Huang X . A randomized study of clofarabine versus clofarabine plus low-dose cytarabine as front-line therapy for patients aged 60 years and older with acute myeloid leukemia and high-risk myelodysplastic syndrome. Blood 2008; 112: 1638–1645.

Garrcia-Manero G Jabbour E Borthakur G . Randomized open-label phase II study of decitabine in patients with low- or intermediate-risk myelodysplastic syndromes. J Clin Oncol 2013; 20: 2548–2553.

Berry DA . Adaptive clinical trials: the promise and the caution. J Clin Oncol 2011; 29: 606–609.

Korn EL Freidlin B . Reply to Y. Yuan et al. J Clin Oncol 2011; 29: e393.

Thall PF Fox PS Wathen JK . Some caveats for outcome adaptive randomization in clinical trials. In: Sverdlov A (ed.) Modern adaptive randomized clinical trials: statistical, operational, and regulatory aspects, in press.

Giles FJ Kantarjian HM Cortes JE . Adaptive randomized study of idarubicin and cytarabine versus troxacitabine and cytarabine versus troxacitabine and idarubicin in untreated patients 50 years or older with adverse karyotype acute myeloid leukemia. J Clin Oncol 2003; 21: 1722–1727.

Kim ES Herbst RS Wistuba II . The BATTLE trial: personalizing therapy for lung cancer. Cancer Discov 2011; 1: 44–53.

Korn EL Freidlin B . Chapter 7. Outcome-adaptive randomization in early clinical trials. In: Matsui S Buyse ME Simon R (eds) Design and analysis of clinical trials for predictive medicine. Boca Raton, FL: CRC Press, 2015.

Simon RM. Genomic clinical trials and predictive medicine. New York: Cambridge University Press, 2013, pp. 30–33.

Collins SP Lindsell CJ Pang PS . Bayesian adaptive trial design in acute heart failure syndromes: moving beyond the mega trial. Am Heart J 2012; 164: 138–145.