High costs of complying with drug development regulations slow progress and contribute to high drug prices and, hence, mounting health care costs...
We are concerned Canadians who have been impacted deeply by cancer. One of us (Stewart) is a cancer physician who has seen far too many patients die; the other (Bradford) is a cancer survivor who has recently lost his beloved wife to cancer. She was directly affected by the issues we raise below...
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...
Common cancers may arise from several different mutations, and each causative mutation may require different treatment approaches. There are also several mechanisms by which malignancies may become resistant to therapy, and each mechanism will also require a different therapeutic strategy.
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...
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...
