This page is maintained by the PhRMA adaptive
dose-ranging studies working group (
Alex
Dmitrienko).
White paper released by the Working Group.
Bornkamp, B., Bretz, F., Dmitrienko, A.,
Enas, G., Gaydos, B., Hsu, C.-H., König, F., Krams, M., Liu,
Q., Neuenschwander, B., Parke, T., Pinheiro, J., Roy, A., Sax,
R., Shen, F. (2007). Innovative approaches for designing and analyzing
adaptive dose-ranging trials. Journal of Biopharmaceutical Statistics.
17, 965-995 [
Download
white paper].
The white paper was published in a special
issue of the Journal of Biopharmaceutical Statistics (Statistical
Issues in Adaptive Design Methods in Clinical Trials) guest-edited
by Vlad Dragalin (Wyeth). Five experts in the area of adaptive
design served as discussants for the white paper: Dr. Carl-Fredrik
Burman (AstraZeneca), Prof. Andy Grieve (King's College London),
Dr. Robert Hemmings (MHRA), Dr. Sergei Leonov (GlaxoSmithKline),
Dr. Sue-Jane Wang (FDA).
The final version of the technical report summarizing the results
of an extensive simulation study performed by the Working Group
will be posted later this tear [
Download
preliminary summary of the simulation study] [
Download
preliminary summary of the simulation study results].
A
WinZip
archive of the complete set of simulation results produced
by the Working Group. This archive includes 252 CSV (comma-separated
value) files with the dose-response profiles for all methods and
scenarios examined in the simulation study. Warning: It is a very
large file (over 19MB).
Read-me
file that contains instructions (naming conventions, etc).
