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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.

Experts Seek Tweaks to FDA Draft Guidance on Clinical Trial Diversity

Recent US Food and Drug Administration (FDA) draft guidance on enhancing clinical trial populations’ diversity should discuss the role of real-world data/evidence (RWD/RWE), comments to FDA say.

The public comment period on FDA’s draft guidance closed with 90 submissions, including from PhRMA, Roche/Genentech, the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center), the National Center for Health Research (NCHR), the American Society of Clinical Oncology (ASCO) and the National Association for Rare Disorders (NORD), among others.

COTA Collaboration: Helping FDA Figure Out What's Possible and What's Not in Embrace of Real-World Evidence

A Conversation With Chief Medical Officer Andrew Norden, MD, MPH, MBA

When it comes to generating evidence that leads to a drug approval, the randomized controlled trial (RCT) is the gold standard. The first published trial appeared in the literature more than 70 years ago,1 and over the past 30 years, the scientific community has developed the principles of evidence-based medicine,2 in which RCT results inform clinical practice guidelines.


BioSpectrum Asia - "Improving trial efficiency and lowering trial costs is a big challenge"

Historically, getting patients in clinical trials is the biggest challenge to healthcare breakthrough. But now data can used to replace patients in clinical trials. A key priority for the life sciences and pharmaceutical industry is to speed up clinical trials in order to bring treatments to market faster. But modernizing clinical trials is easier said than done, with the large number of participants needed for trials and participants’ fears of being assigned to placebo (‘fake’ treatment) proving to be a challenge.

Cure - A Trial for Every Patient and a Patient for Every Trial

Clinical trials can be less reflective of the general population with cancer, due to the exclusion of those with certain comorbidities. The use of expanded clinical trial inclusion criteria would nearly double the percentage of patients eligible to enroll in clinical trials, according to the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research.


The researchers drew this conclusion based on a study that examined the health records of over 10,000 patients with advanced non–small cell lung cancer (NSCLC) from ASCO’s CancerLinQ database.


Oncology Nursing News - Patients With HIV May Be Good Candidates for Cancer Clinical Trials

Cancer clinical trials have been notoriously exclusive, and for years there has been no exception when it comes to patients with HIV. However, according to recent research, patients with lymphoma, Kaposi sarcoma, and liver cancer who were HIV-positive benefitted from treatment with pembrolizumab (Keytruda), and had a similar adverse event (AE) profile. This highlights the fact that many trials can be expanded to include patients with HIV.


The Cancer Letter - Medicaid should pay for patients to enroll in clinical trials, coalition tells Congress

The bill, H.R. 913, was introduced in the House of Representatives by Rep. Ben Ray Lujan (D-NM) and Rep. Gus Bilirakis (R-FL).

“Clinical trials have tremendous potential to help patients with life-threatening illnesses, and for patients with cancer, clinical trials of ten of fer the best available treatment option,” Howard A. Burris, president of American Society of
Clinical Oncology, said in a statement. “It is imperative that every patient, regardless of how they are insured, have access to clinical trials.”