University of Pennsylvania ninth annual conference on statistical issues in clinical trials: Where are we with adaptive clinical trial designs? (morning panel discussion)

Bretz F Gallo P Maurer W . Adaptive designs: the Swiss Army knife among clinical trial designs? Clin Trials. Epub ahead of print 22 March 2017. DOI: 10.1177/1740774517699406.

Wathen JK Thall PF . A simulation study of outcome adaptive randomization in multi-arm clinical trials. Clin Trials. Epub ahead of print 1 February 2017. DOI: 10.1177/1740774517692302.

Du Y Wang X Lee J . Simulation study for evaluating the performance of response-adaptive randomization. Contemp Clin Trials 2015; 40: 15–25.

Bowden J Trippa L . Unbiased estimation for response adaptive clinical trials. Stat Methods Med Res. Epub ahead of print 11 August 2015. DOI: 10.1177/0962280215597716.

Parmer M Sydes MR Cafferty FH et al . Testing many treatments within a single protocol over 10 years at MRC CTU at UCL Multi-arm, multi stage platform, umbrella and basket protocols. Clin Trials, 2017, Vol. 14(5) 451–461 http://journals.sagepub.com/doi/full/10.1177/1740774517725697.

Connor JT Broglio KR Durkalski V et al . The Stroke Hyperglycemia Insulin Network Effort (SHINE) trial: an adaptive trial design case study. Trials 2015; 16: 72.

Connor JT Elm JJ Broglio KR ; ESETT and ADAPT-IT Investigators. Bayesian adaptive trials offer advantages in comparative effectiveness trials: an example in status epilepticus. J Clin Epidemiol 2013; 66: S130–S137.

Emanuel EJ Wendler D Killen J et al . What makes clinical research in developing countries ethical? The benchmarks of ethical research. J Infect Dis 2004; 189: 930–937.

Joffe S Ellenberg SS . Commentary on Hey and Kimmelman. Clin Trials 2015; 12: 116–118.

Bartlett RH Roloff DW Cornell RG et al . Extracorporeal circulation in neonatal respiratory failure: a prospective randomized study. Pediatrics 1985; 76: 479–487.

Brown CH Ten Have TR Jo B et al . Adaptive designs for randomized trials in public health. Annu Rev Public Health 2009; 30: 1–25.

Zelen M . Play the winner rule and the controlled clinical trial. J Am Stat Assoc 1969; 325: 131–146.

Ware JH . Investigating therapies of potentially great benefit: ECMO. Stat Sci 1989; 4: 298–306.

Berry DA . Investigating therapies of potentially great benefit: ECMO: comment: ethics and ECMO. Stat Sci 1989; 4: 306–310.

Kalbfleisch JD Prentice RL . The statistical analysis of failure time data. 2nd ed. Hoboken, NJ: Wiley, 2002.

Simon N Simon R . Adaptive enrichment designs for clinical trials. Biostatistics 2013; 14: 613–625.

Jennison C Turnbull BW . Group sequential methods with applications to clinical trials. 1st ed. Boca Raton, FL: Chapman & Hall/CRC, 1999.

Karrison TG Huo D Chappell R . A group sequential, response-adaptive design for randomized clinical trials. Control Clin Trials 2003; 24: 506–522.

Zang Y Lee JJ . Adaptive clinical trial designs in oncology. Chin Clin Oncol 2014; 3: 49.

Luce BR Connor JT Broglio KR et al . Using Bayesian adaptive trial designs for comparative effectiveness research: a virtual trial execution. Ann Intern Med 2016; 165: 431–438.

Davis BR Cutler JA Gordon DJ et al . Rationale and design for the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). ALLHAT Research Group. Am J Hypertens 1996; 9: 342–360.

ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA 2002; 288: 2981–2997.

Proschan M Brittain E Kammerman L . Minimize the use of minimization with unequal allocation. Biometrics 2011; 67: 1135–1141.

Weinstein SL Dolan LA Wright JG et al . Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med 2013; 369: 1512–1521.

Uno H Wei LJ Hughes M . Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med 2014; 370: 680–681.

National Research Council (US) Panel on Handling Missing Data in Clinical Trials (eds). The prevention and treatment of missing data in clinical trials. Washington, DC: The National Academies Press, 2010.