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…
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…
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…
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…
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…
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. Interesting, important, and sometimes surprising findings…
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.…
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.,…
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…
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,…
