In what probably came as a surprise to many, U.S. Food and Drug Administration Commissioner Dr. Scott Gottlieb announced his resignation on Tuesday. He’ll end his two-year tenure aggressively heading the agency in a month, an administration official told the Washington Post. “All of us at HHS are proud of the remarkable work…
A lot can be said of Washington in 2019. Talk of government dysfunction and party politics clouds even the simplest conversations and policies. Working in government, once held up as a way to serve our country, has turned into a partisan attack line. But there are some exceptions. Scott Gottlieb, through his deep respect…
Within hours of the announcement that FDA Commissioner Scott Gottlieb will be resigning from the agency in a month, an array of stakeholders sent out their near-universal applause of the commissioner’s leadership and policy initiatives. Though representatives of industry spoke fondly of the outgoing agency chief, Michael Carome, director of the Health Research Group…
Food and Drug Commissioner Scott Gottlieb, who used his post to tackle difficult public health issues from youth vaping to opioid addiction – surprising early skeptics worried about his drug industry ties – resigned Tuesday, effective in about a month. Gottlieb, who has been commuting weekly to Washington from his home in Connecticut, said…
Today we are discussing cancer clinical trial participation with Joseph Unger, PhD, MS, a health services researcher and biostatistician who is part of the public health sciences division at the Fred Hutchinson Cancer Research Center in Seattle and an assistant professor at the University of Washington’s School of Public Health. Professor Unger focuses on ways…
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…
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…
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. A study published Jan. 10 in JAMA…
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. Patients ages 15–39, having transitioned…
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…
