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Cancer Today - Making Clinical Trials More Inclusive

SOME CANCER PATIENTS hope to join clinical trials, both to gain access to new treatments and to help improve treatment for future patients. Yet clinical trial eligibility requirements often state that cancer patients who also have other medical conditions, called comorbid conditions, cannot participate in the trial.


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."


The Cancer Letter - Gottlieb: FDA to expand real-world data infrastructure to enhance AI capabilities

FDA is enhancing its ability to handle real-world evidence by training reviewers in data science via a curriculum on machine learning and artificial intelligence, said FDA Commissioner Scott Gottlieb.


“We’re working to develop new guidance documents to assist sponsors interested in developing and using real-world evidence,” Gottlieb said at a Jan. 28 panel discussion organized by the Bipartisan Policy Center.


Inside Health Policy - Former FDA Heads Debate FDA’s Role In Using RWE To Assess Value

A pair of former FDA commissioners debated whether FDA should take the lead on using real-world data and real-world evidence to determine the actual value of drug therapies and in turn ensure the value translates to affordable prices. While one said he believes FDA is uniquely positioned to push widespread use of RWD to help people become healthier, the other contended that multiple components of the health system need to step up if such data is to be used in value-based payment contracts.


Endpoints News - Gottlieb lays out real world evidence priorities for 2019 with an eye on digital tools

Stressing the need for speed and efficiency, FDA Commissioner Scott Gottlieb on Monday offered a look at FDA’s plans around real-world data (RWD) and real-world evidence (RWE) in 2019.


The speech at the Bipartisan Policy Center built off a framework, released in December, that sought to begin the conversation on how RWD and RWE can support changes to labeling, including adding or modifying an indication, changes in dose, dose regimen or route of administration; changing or adding new populations; or the addition of comparative effectiveness or safety information.

STAT - Real-world evidence is changing the way we study drug safety and effectiveness

Randomized controlled clinical trials are a great way to test the safety and effectiveness of a new drug. But when the trial is over and the drug approved, it’s used by patients and health care practitioners in settings that are quite different from the rarified clinical trial setting.


BioSpace - FDA’s Gottlieb Presents Approach to Real-World Evidence in Clinical Trials

Real-world evidence (RWE) or real-world data (RWD) relates to the collection of information about a drug’s safety and efficacy outside the structure of a clinical trial. Speaking yesterday at the Bipartisan Policy Center conference, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb laid out the FDA’s new framework for dealing with RWE and RWD.