It takes on average 6–12 years to develop new anticancer drugs from discovery to approval. Effective new agents prolong survival. To demonstrate the importance of rapid drug approval, we calculated life-years potentially saved if selected agents [...]
This commentary reviews the evolution of the process of cancer research in the United States over the past 6 decades, from an academic-based to drug industry-based research, and the advantages and concerns. It proposes a [...]
High costs of complying with drug development regulations slow progress and contribute to high drug prices and, hence, mounting health care costs...
Interesting new research suggests that the burden of proof required by Canada’s health technology assessment (HTA) process for new drugs is too rigid and unfairly excludes many treatments for rare disorders from public drug insurance coverage...
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.
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...
Randomized controlled trials with a survival endpoint are the gold standard for clinical research, but have failed to achieve cures for most advanced malignancies. The high costs of randomized clinical trials slow progress (thereby causing avoidable loss of life) and increase health care costs...
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...
