Readings
Readings are below. You have to be using a JHU computer, since the links are via the library proxy to the journal's version of the article. After clicking on the link on this page, you should click on one of the links that appears below "Electronic Version via:" and you're immediately redirected to the journal website with the article on that page. Then click on appropriate link (e.g. "pdf" or "fulltext pdf") to download article.
April 9:
Fleming, T. R. (2006) Standard versus adaptive monitoring procedures: a commentary. Statistics in Medicine. 25: 19. 3305-3312. DOI: 10.1002/sim.2641
Wittes, J., and Lachenbruch, P. (2006) Discussion: Opening the Adaptive Toolbox. Biometrical Journal. 4, 598-603. DOI: 10.1002/bimj.200610240
April 12: U.S. FDA Guidances. Adapting Randomization Probabilities
U.S. F.D.A. (2010) Draft Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics
April 19: Adapting Randomization Probabilities
Feifang Hu, William F Rosenberger. (2004) Maximizing power and minimizing treatment failures in clinical trials. Clinical Trials. 1:141. http://ctj.sagepub.com/cgi/content/abstract/1/2/141
[Here's the more theoretical version of above paper:]
Feifang Hu, William F Rosenberger. (2003, September) Optimality, Variability, Power: Evaluating Response Adaptive Randomization Procedures for Treatment Comparisons. Journal of the American Statistical Association. 98(463): 671-678. doi:10.1198/016214503000000576.
April 23: Adapting Sample Size
Scharfstein DO, Tsiatis AA, Robins JM (1997). Semiparametric efficiency and its implication on the design and analysis of group sequential studies. Journal of the American Statistical Association. 92(44): 1342-1350.
Anastasios A.Tsiatis and Cyrus Mehta. (2003) On the inefficiency of the adaptive design for monitoring clinical trials. Biometrika. 90(2):367-378; doi:10.1093/biomet/90.2.367
April 26: Seamless Phase II/III Designs
This is the paper I suggested for getting ideas for simulations:
(See especially Sections 5-8)
Jennison C, Turnbull BW. (2006) Confirmatory seamless phase II/III clinical trials with hypothesis selection at interim: opportunities and limitations. Biometrical Journal. 48:650–655.
Jennison, C. and Turnbull, B.W. (2007) Adaptive seamless designs: Selection and prospective testing of hypotheses. J. Biopharmaceutical Statistics, 1135-1161; doi: 10.1080/10543400701645215.
Tim Friede and Nigel Stallard. (2008) A Comparison of Methods for Adaptive Treatment Selection. Biometrical Journal. 50 5, 767–781 DOI: 10.1002/bimj.200710453
April 30: Adapting Hypothesis Tested
Gerhard Hommel. Adaptive Modifications of Hypotheses After an Interim Analysis
Biometrical Journal. 43 (2001) 5, 581–589
Rosenblum and van der Laan. [Link to be posted soon, still making some revisions] (2009, April) Optimizing Group Sequential Designs that Allow Pre-planned Changes to the Population Sampled Based on Interim Data. Proceedings of the 57th Session of the International Statistical Institute. Durban, South Africa.
May 3: Bayesian Designs (Guest Lecture by Gary Rosner)
Barker, AD, Sigman, CC, Kelloff, GJ, Hylton, NM, Berry, DA, and Esserman, LJ (2009),
I-SPY 2, An Adaptive Breast Cancer Trial Design in the Setting of Neoadjuvant Chemotherapy
Berry, DA, Mueller, P, Grieve, AP, Smith, M, Parke, T, Blazek, R, Mitchard, N, Krams, M (1999)
Adaptive Bayesian Designs for Dose-Ranging Drug Trials
Rosner, GL, and Bekele, BN
Bayesian Designs in Clinical Trials
Giles, FJ, Kantarjian, HM, Cores, JE, Garcia-Manero, G, Verstovsek, S, Faderl, S et al. (2003)
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
Zhou, X, Liu, S, Kim, ES, Herbst, RS, Lee, JJ (2008)
Bayesian adaptive design for targeted therapy development in lung cancer-a step toward personalized medicine
Michael Rosenblum
Last modified: Sun Apr 25 19:40:13 EDT 2010