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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.


BioCentury - Lung-MAP Expands to Include All Advanced NSCLC Patients

SWOG's Lung Cancer Master Protocol (Lung-MAP) precision medicine trial is implementing new protocols and expanding to include all advanced stage non-small cell lung cancer patients, moving beyond its initial population of advanced stage squamous cell lung cancer. The new population of patients in Lung-MAP comprises about 85% of all lung cancer diagnoses in the U.S., according to SWOG.


Healio - Lung-MAP expands to include all patients with non-small cell lung cancer

The Lung Cancer Master Protocol, or Lung-MAP, will expand to include all patients diagnosed with non-small cell lung cancer.


Lung-MAP — the first large-scale precision medicine lung cancer trial backed by the NCI — is supported by a partnership with NCI’s National Clinical Trials Network, SWOG Cancer Research Network, Friends of Cancer Research, the Foundation for the National Institutes of Health, Foundation Medicine, pharmaceutical companies and lung cancer advocacy organizations.

OncLive - NCI Moves to Expand Clinical Trial Eligibility Criteria

In an effort to ensure that study participants are more reflective of real-world populations, the National Cancer Institute (NCI) has revised its clinical trial protocols to expand access for previously excluded patients. The revisions affect potential participants with preexisting conditions in 5 categories: those with brain metastases, prior and current malignancies, HIV and hepatitis infection, and organ dysfunction, as well as patients under the age of 18 years.


Cure Today - Comorbidities Associated with Lower Clinical Trial Participation

Patients with cancer who also have other health issues are less likely to participate in a clinical trial, potentially leaving gaps in understanding how drugs may affect individuals with certain comorbidities, according to recent research published in JAMA Oncology.


Oncology Nurse Advisor - Modernizing Eligibility Criteria Could Increase Access to, Participation in Clinical Trials

Presence of comorbidities is associated with fewer patient-physician discussions regarding clinical trials, with fewer offers made and less patient participation, according to a report published in JAMA Oncology. Updating eligibility criteria would increase access to new treatments in trials.