The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research is responsible for evaluating drug safety and efficacy, including oversight of clinical trials and principal investigators...
Randomized, clinical trials are the strongest method we have to define the efficacy of new drugs. Recently, however, novel agents that show remarkable responses with minimal toxicity in patients with advanced cancer have been discovered [1], and these present a challenge for the ethical conduct of randomized trials...
Regulations and ethical principles require that investigators seek consent and that patients participate in experimental studies only under circumstances that minimize the possibility of undue pressure and/or enticements...
Cancer is the leading cause of death in Americans younger than 85 years of age and kills one American every 56 seconds. Advances in understanding of cancer biology have given us the potential to develop new, effective targeted therapies...
THE PROBLEM After impressive victories against hematologic and germ cell malignancies, the battle against common epithelial cancers has evolved into a grinding war of the trenches, where statistical victories...
