RT Journal
A1 Koschmann C, Thomson B, Hawkins DS
T1 NO evidence of a trial effect in newly diagnosed pediatric acute lymphoblastic leukemia
JF Archives of Pediatrics & Adolescent Medicine
JO Archives of Pediatrics & Adolescent Medicine
YR 2010
FD March 1
VO 164
IS 3
SP 214
OP 217
DO 10.1001/archpediatrics.2009.282
UL http://dx.doi.org/10.1001/archpediatrics.2009.282
AB Objective 
    To determine whether clinical trial enrollment by itself is associated with improved outcome.Design 
    Retrospective cohort study.Setting 
    Seattle Children's Hospital from 1997 to 2005.Participants 
    Data were drawn from 322 patients with newly diagnosed acute lymphoblastic leukemia.Main Exposure 
    Enrollment in a Children's Oncology Group or Children's Cancer Group clinical trial.Main Outcome Measures 
    (1) Demographic variables associated with trial participation. (2) Event-free survival, which was defined as the time from initial diagnosis to either leukemia recurrence or death from any cause.Results 
    No outcome advantage was found for participants in a clinical trial compared with nonparticipants. Additionally, there were not demographic factors associated with increased clinical trial participation.Conclusions 
    Clinical trial participation does not, by itself, lead to improved outcome for pediatric patients with acute lymphoblastic leukemia in the current era. Discussions about participation in a clinical trial should focus on improvement of future therapy, not the direct benefit of the research participant.