Planning and analysis of repeated measures at key time-points in clinical trials sponsored by pharmaceutical companies.
In this paper we explore the possible reasons why medical papers reporting clinical trials sponsored by the pharmaceutical industry often analyse repeated measures data at certain key time-points instead of employing sophisticated models of repeated measures proposed by many statisticians. A survey indicated that the priority reason in the industry for having repeated measures in clinical trials is to monitor the trial and to utilize the early results for strategic decision making. We discuss what the common statistical methods do and do not offer for analysis of repeated measures in such clinical trials. We advocate the need to improve the understanding of the medical interest in conducting longitudinal trials in the industry, and to plan and analyse the repeated measures accordingly. We address the medical interest by formulating the problem and give illustrative examples for both phases II and III trials.
Shih
W J
WJ
Biostatistics and Research Data Systems, Merck Research Laboratories, Rahway, New Jersey 07065, USA.
Quan
H
H
D019386:Alendronate / Q000494:pharmacology / Q000627:therapeutic use; D017322:Clinical Trials, Phase II as Topic / Q000379:methods / Q000706:statistics & numerical data*; D017326:Clinical Trials, Phase III as Topic / Q000379:methods / Q000706:statistics & numerical data*; D003625:Data Collection; D003657:Decision Making; D004345:Drug Industry / Q000191:economics / Q000706:statistics & numerical data*; D004791:Enzyme Inhibitors / Q000494:pharmacology / Q000627:therapeutic use; D005260:Female; D018120:Finasteride / Q000494:pharmacology / Q000627:therapeutic use; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D010024:Osteoporosis / Q000188:drug therapy; D010510:Periodontal Diseases / Q000188:drug therapy; D011470:Prostatic Hyperplasia / Q000188:drug therapy; D013223:Statistics as Topic / Q000379:methods*; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration
D004791:Enzyme Inhibitors; D018120:Finasteride; D019386:Alendronate