Use of surrogate information time for monitoring the effect of treatment on the change in a response variable in clinical trials.
We discuss the monitoring of clinical trials data and propose two surrogates for total information for use with the spending function approach where there are repeated measurements and we wish to compare the rates of change in a response variable under different treatments. These surrogates are applied to a setting similar to the Lung Health Study. Although the surrogates do not require estimation of the variance parameters, they do require some knowledge of the ratio R of the within- to the between-individual variances. The effects of overestimating and underestimating R are illustrated. In situations of uncertainty we recommend overestimating R, to provide a conservative estimate of information time at each interim analysis.
Wu
M C
MC
Biostatistics Research Branch, National Heart, Lung and Blood Institute, Bethesda, MD 20892.
Lan
K K
KK
Connett
J E
JE
D000328:Adult; D001993:Bronchodilator Agents / Q000008:administration & dosage; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003131:Combined Modality Therapy; D003627:Data Interpretation, Statistical; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005541:Forced Expiratory Volume; D006801:Humans; D016014:Linear Models; D008137:Longitudinal Studies; D008173:Lung Diseases, Obstructive / Q000628:therapy; D008297:Male; D008875:Middle Aged; D015233:Models, Statistical; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D012907:Smoking / Q000009:adverse effects; D016540:Smoking Cessation / Q000706:statistics & numerical data; D000074606:Smoking Prevention
D001993:Bronchodilator Agents