Statistical designs for early phases of cancer clinical trials.
The main purpose of a Phase I trial of a new antitumor agent is to determine the appropriate dosing regimen and characterize the safety profile of a new molecular or monoclonal antibody. Phase II cancer clinical trials are conducted to assess the efficacy of a new anticancer therapy and to determine whether it has sufficient activity against a specific type of tumor to warrant further development. In this paper, commonly used statistical designs, based on either frequentist approaches or Bayesian methods, for Phase I and Phase II cancer clinical trials are reviewed and discussed. Future directions of designing more efficient trial are explored.
Merck Research Laboratories, North Wales, PA 19454, USA. shanhong_guan@merck.com
Shanhong
S
Guan
D000465:Algorithms; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001499:Bayes Theorem; D017321:Clinical Trials, Phase I as Topic / Q000379:methods* / Q000706:statistics & numerical data*; D017322:Clinical Trials, Phase II as Topic / Q000379:methods* / Q000706:statistics & numerical data*; D004305:Dose-Response Relationship, Drug; D006801:Humans; D015233:Models, Statistical; D012107:Research Design / Q000706:statistics & numerical data*
D000970:Antineoplastic Agents