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Washington Post - Biden holding cancer summit to pump up support for ‘moonshot’ effort

Vice President Biden will convene a day-long cancer summit in Washington on Wednesday that will be part pep rally, part Ted talk, part wonk-a-thon — all designed to garner support for the Obama administration’s year-long initiative to advance cancer research.

The summit, expected to draw as many as 300 people from academia, industry and advocacy groups to Howard University, is billed as a way to generate new ideas to beat a disease that kills almost 600,000 Americans a year. Dozens of regional summits will take place at the same time.

Bloomberg - Breakthrough Drugs Developed, Reviewed Faster

The FDA's breakthrough therapy designation has led to shorter drug development times and shorter FDA review times, industry experts said April 12 during a Senate briefing.

Enacted in July 2012 as part of the Food and Drug Administration Safety and Innovation Act (Pub. L. No. 112-144), the breakthrough therapy designation expedites the development and review of drugs for serious or life-threatening conditions if the drug has demonstrated substantial improvement on at least one clinically significant endpoint over available therapies.

The Washington Post - He won his own battle against cancer. Biden just picked him to lead a war

Greg Simon was on his way to visit a friend in San Francisco in 2014 when he called his doctor to get the results of a long-overdue physical. Your cholesterol and PSA tests are fine, his doctor said. But, he added, you have leukemia.

The Scientist - The Challenges of Precision

The amount of genetic variation between cancer patients is astounding. Two people diagnosed with cancer in the same organ may, in fact, have two very different diseases. Consequently, we are now in the middle of a transition: we no longer classify cancer based solely on its tissue of origin, but also on the key mutations driving growth and spread of a patient’s tumor.

Pink Sheet - Real-World Evidence Takes Courage: A Conversation With IQVIA’s Nancy Dreyer

Executive Summary

Emerging standards for regulatory use of RWE should resist the temptation to impose the standards and expectations of randomized clinical trials to a fundamentally different kind of evidence, Dreyer cautions.

 

As the 21st Century Cures Act’s vision for real-world evidence lumbers from legislation to application in the reality of regulatory decision-making, the Pink Sheet asked an expert in the use of real-world data, IQVIA Real-World & Analytic Solutions Global Chief of Scientific Affairs Nancy Dreyer, about the hurdles still ahead.

 

Applied Clinical Trials Online - FDA Policies Support Shift to Decentralized Clinical Trials

A notable benefit of using wearable devices and other innovative technology to collect patient data in real-time is to encourage the design and implementation of clinical trials conducted at the point of care. Such approaches can help biomedical research “become more agile and efficient” and reduce the cost of developing important new therapies, FDA commissioner Scott Gottlieb said in a January 2019 policy speech designed to expand discussion and debate over how real-world data (RWD) and real-world evidence (RWE) can be utilized to support a range of drug development goals.

 

Pharmaceutical Technology - Young adults with cancer need clinical pathways

Cancer in adolescents and young adults

Her untimely death has once again shone a light on a global subgroup of 1 million cancer patients, referred to as adolescents and young adults (AYA), who, as of yet, do not have a specific clinical pathway in oncology based on clinical-trial-supported data.

 

The ASCO Post - Lung-MAP Precision Medicine Trial Expands

The Lung Cancer Master Protocol (Lung-MAP), the first precision medicine trial in lung cancer supported by the National Cancer Institute (NCI), is undergoing a major expansion to include patients with all non–small cell lung cancers (NSCLCs).

 

The trial previously tested treatments for people with advanced-stage squamous cell lung cancer. Opening the trial to all types of advanced-stage NSCLCs means that thousands of new patients will be eligible to enroll.

 

The Cancer Letter - Lung-MAP precision medicine trial expands

The Lung Cancer Master Protocol is undergoing a major expansion to include patients with all non-small cell lung cancers.

 

The trial previously tested treatments for people with advanced stage squamous cell lung cancer. The trial is now open to all types of advanced stage non-small cell lung cancers. NSCLC makes up about 85 percent of all lung cancer diagnoses in the U.S.

 

This month, Lung-MAP will undergo other key changes. These include:

 

Journal of Clinical Pathways - Comorbidity exclusion criteria impair participation in cancer trials

Easing comorbid-condition exclusion criteria could significantly increase participation in clinical trials for cancer, researchers report.

 

"Some eligibility exclusions for comorbid conditions will always remain for the sake of patient safety," Dr. Joseph M. Unger from Fred Hutchinson Cancer Research Center, in Seattle, told Reuters Health by email. "But others should be modified or removed if evidence shows that patients with those conditions can be safely enrolled."

 

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