A proposal for a new approach to intergroup cancer trials.
Currently, North American intergroup trials are conducted according to the Intergroup Guidelines, which require that a lead group take responsibility for data management. Intergroup studies conducted in this manner have been very successful in rapidly accruing large numbers of patients to trials addressing significant questions, but it has been difficult for group statistical centres to cope with the resultant peaks in data flow. Our groups recently succeeded in combining the data from three independently designed and conducted trials to carry out a planned pooled analysis. This experience has led us to employ the same approach to data management in designing a forthcoming intergroup trial. We will use a common protocol and capture the same data elements on our forms, but each group will be responsible for the collection and quality control of its own data. A common data set will be created and updated periodically during the study, and will be used for the final analysis. We suggest that this model has advantages over the current approach to data management on intergroup trials, but still retains the features which distinguish an intergroup study from meta-analysis.
Pater
J L
JL
NCIC Clinical Trials Group, Queen's University, Kingston, Ontario, Canada.
Zee
B
B
Myles
J
J
Pignon
J P
JP
Milan
C
C
Sahmoud
T
T
Torri
V
V
Marsoni
S
S
D002986:Clinical Trials as Topic / Q000379:methods*; D003627:Data Interpretation, Statistical; D006801:Humans; D015201:Meta-Analysis as Topic; D015337:Multicenter Studies as Topic / Q000379:methods*; D009369:Neoplasms / Q000628:therapy*