Group sequential analyses for the mean function of a repeated measure process.
In many clinical trials, treatment efficacy is based upon response to a biological marker that is measured repeatedly during the course of follow-up. However, in some of these trials it is not clear, a priori, how treatment effects on the marker may manifest themselves or what kinds of effects are clinically meaningful and/or acceptable. It is, therefore, desirable to allow flexibility in design and monitoring process by not prespecifying a stopping rule or even the parameter on which inferences will be based. Using the more general results in Hu and Lagakos, this paper extends the idea of the repeated confidence intervals for a parameter (Jennison and Turnbull) to repeated confidence bands for the mean function of a repeated measure process. We illustrate the approach and some considerations in its application with the results of a recent AIDS clinical trial.
Hu
X J
XJ
Department of Biostatistics, Harvard School of Public Health, 655 Huntington Ave., Boston, MA 02115, USA.
Lagakos
S W
SW
D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D017322:Clinical Trials, Phase II as Topic / Q000706:statistics & numerical data*; D016001:Confidence Intervals; D003627:Data Interpretation, Statistical; D016049:Didanosine / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000235:genetics / Q000502:physiology*; D006801:Humans; D008297:Male; D015337:Multicenter Studies as Topic; D019829:Nevirapine / Q000627:therapeutic use; D012367:RNA, Viral / Q000097:blood; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use; D019562:Viral Load / Q000592:standards; D015215:Zidovudine / Q000627:therapeutic use
D019380:Anti-HIV Agents; D012367:RNA, Viral; D018894:Reverse Transcriptase Inhibitors; D015215:Zidovudine; D019829:Nevirapine; D016049:Didanosine