468
Views
5
CrossRef citations to date
0
Altmetric
Articles

Seamless Phase IIa/IIb and enhanced dose-finding adaptive design

, , , , &
Pages 912-923 | Received 14 Sep 2014, Accepted 04 Sep 2015, Published online: 12 Feb 2016

References

  • Bretz, F., Maurer, W., Brannath, W., Posch, M. (2009). A graphical approach to sequentially rejective multiple test procedures. Statistics in Medicine 28:586–604.
  • Bretz, F., Maurer, W., Hommel, G. (2011b). Test and power considerations for multiple endpoint analyses using sequentially rejective graphical procedures. Statistics in Medicine 30:1489–1501.
  • Bretz, F., Posch, M., Glimm, E., Klinglmueller, F., Maurer, W., Rohmeyer, K. (2011a). Graphical approaches for multiple comparison procedures using weighted bonferroni, simes or parametric tests. Biometrical Journal 53:894–913.
  • Bretz, F., Schmidli, H., König, F., Racine, A., Maurer, W. (2006). Confirmatory seamless phase II/III clinical trials with hypothesis selection at interim: General concepts. Biometrical Journal 48:623–634.
  • Chow, S. C., Lu, Q., Tse, S. K. (2007). Statistical analysis for two-stage seamless design with different study endpoints. Journal of Biopharmaceutical Statistics 17:1163–1176.
  • Chow, S. C., Tu, Y. H. (2008). On two-stage seamless adaptive design in clinical trials. Journal of the Formosan Medical Association 107:52–60.
  • Gooley, T. A., Martin, P. J., Fisher, L. D., Pettinger, M. (1994). Simulation as a design tool for phase I/II clinical trials: An example from bone marrow transplantation. Controlled Clinical Trials 15:450–462.
  • Hoering, A., LeBlanc, M., Crowley, J. (2011). Seamless phase I-II trial design for assessing toxicity and efficacy for targeted agents. Clinical Cancer Research 17:640–646.
  • Rosenberg, M. J. (2010). The Agile Approach to Adaptive Research: Optimizing Efficiency in Clinical Development. Hoboken, NJ: Wiley.
  • Schmidli, H., Bretz, F., Racine, A., Maurer, W. (2006). Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim. Part II: Applications and practical considerations. Biometrical Journal 48:635–643.
  • Stallard, N., Todd. S. (2010). Seamless phase II/III designs. Statistical Methods in Medical Research 20:623–634.
  • Thall, P. F., Russell, K. T. (1998). A strategy for dose-finding and safety monitoring based on efficacy and adverse outcomes in phase I/II clinical trials. Biometrics 54:251–264.
  • Thall, P. F., Cook, J. D. (2004). Dose-finding based on efficacy-toxicity trade offs. Biometrics 60:684–693.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.