Cross-trial networking in AML: a step forward rather than corner cutting.
In order to further activate the therapeutic progress against acute myeloid leukemia (AML), we recently proposed cross-trial networking based on general upfront randomization and a common standard arm. A representative standard arm of uniform treatment is recruited by random allocation of 10% patients from each participating trial. The trial own control arms are maintained and can be calibrated with the common standard arm as reference. Upfront randomization, assessment of prognostic profiles, monitoring of protocol adherence and evaluation of outcome in the standard arm are done centrally. By its design the network allows prospective comparisons and validations of specific treatment strategies across the trials, and treatments superior beyond the limits of individual trials can be identified. Recent experiences about intent-to-treat evaluation as well as a new consensus on shared protocol standards support this project.
Büchner
Thomas
T
Department of Medicine, Hematology and Oncology, University of Münster, Albert-Schweitzer-Street 33, D-48129 Münster, Germany. buechnr@uni-muenster.de
Döhner
Hartmut
H
Ehninger
Gerhard
G
Ganser
Arnold
A
Niederwieser
Dietger
D
Hasford
Joerg
J
D000208:Acute Disease; D002985:Clinical Protocols / Q000592:standards*; D006801:Humans; D007951:Leukemia, Myeloid / Q000628:therapy*; D018579:Patient Selection; D011897:Random Allocation; D016032:Randomized Controlled Trials as Topic / Q000592:standards*