April 29, 2024

Countries face challenges in paying for new drugs. High prices are driven in part by exploding drug development costs, which, in turn, are driven by essential but excessive regulation. Burdensome regulation also delays drug development, and this can translate into thousands of life-years lost. [...]

November 16th, 2023

Abstract Historically, subject matter experts and healthcare professionals have played a pivotal role in driving oncology clinical trials. Although patients have been key participants, their deliberate and active contribution to the design and decision-making process has been limited. [...]

March 1st, 2023

Introduction Predictive oncology, germline technologies, and adaptive seamless trials are promising advances in the treatment of lethal cancers. Yet, access to these therapies is stymied by costly research, regulatory barriers, and structural inequalities worsened by the [...]

February 23rd, 2022

"New drugs are expensive, in part due to excessive drug development costs. Governments are trying to reduce drug prices. This can delay access to effective agents. A country’s access to new drugs correlates with prices they agree [...]

November 12th, 2021

Background Systemic therapy prolongs overall survival (OS) in advanced non-small cell lung cancer (NSCLC), but diagnostic tests, staging and molecular profiling take time, and this can delay therapy initiation. OS approximates first-order kinetics. Methods We [...]

September 10th, 2019

Background Canada has an established publicly funded health care system with a complex drug approval and funding process. After proof of efficacy (POE; key publication/presentation) and before becoming publicly accessible, each drug undergoes a Health Canada approval process, a health [...]

May 30th, 2018

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 were approved more rapidly. As [...]

May 14th, 2018

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 new form of cancer research [...]

October 14th, 2015

High costs of complying with drug development regulations slow progress and contribute to high drug prices and, hence, mounting health care costs...

April 15th, 2014

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...

February 23rd, 2014

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.

October 1st, 2013

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...

April 16th, 2013

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...

March 1st, 2013

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...

June 10th, 2010

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...

December 8th, 2008

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...