Statistics Clinical Trial Design: An Oncology Perspective

摘要

Clinical trials in veterinary oncology are growing in scope and importance. Trials that evaluate novel therapies for pet animals with cancer have the opportunity to improve the outcome and quality of life (QOL) for veterinary patients, as well as human patients with cancer. The demand for clinical trials has been fueled by a sustained increase in the number of pet animals diagnosed with cancer and the pet-owning public's interest in finding effective and well-tolerated treatments for their pets. Interestingly, the outcome for patients who are managed within a clinical trial has been consistently shown to be superior to that of patients who receive the same agents outside the setting of a clinical study. This suggests that clinical trials are of value not only for improving care of future patients, but also for those patients enrolled in a study. Through the conduct of clinical trials, our opportunities to prevent, diagnose, and treat cancer will continue to improve. It is likely that the availability of clinical trials in veterinary oncology will also continue to expand. This expansion will require and welcome greater direct and indirect participation from both primary care veterinarians and veterinary specialists. The goals of this lecture are tointroduce concepts of clinical trial design and conduct and to review the statistical tests readily used in their analysis.