Statement about Randomization Error in the ACOSOG Z9001 Clinical Study
The following statement has been written by the American College of Surgeons Oncology Group. It is referring to a clinical trial for GIST patients that is intended to see if 400mg of Gleevec following surgery is successful in preventing a relapse-this is called adjuvant, or preventive, treatment.
A randomization error has occurred which will result in some patients having to be removed from the trial and which will cause the trial study period to be lengthened. Although the individual patients who will be dropped form the trial will suffer no adverse results-they will continue to be monitored and will now know whether they were on a placebo-the study information about adjuvant treatment will be delayed.
The study sponsors, the American College of Surgeons, have been very forthcoming and cooperative in explaining and responding to this issue.
Norman J. Scherzer
Exec. Director, The Life Raft Group
