Jeff Allen, president and CEO of Friends of Cancer Research, shares what he hopes continuing advancements and the Cancer Moonshot will achieve in cancer care. Allen expressed that one day he hopes that cancer treatments become more widely available for people. This includes getting them on to the marker earlier by speeding…
Strong data science is critical to getting a better understanding of clinical trial results — and perhaps no one understands that better than the Food and Drug Administration. So the agency’s Oncology Center for Excellence has harnessed computer modeling tools to help make better sense of clinical data — so as to help guide…
Bipartisanship prevailed on a health issue Wednesday, as the Senate teed up a revised version of Sen. Ron Johnson’s “right-to-try” bill in a move that both clears the way for a quick reauthorization of an FDA funding package and blocks the agency from interfering with terminally ill patients seeking access to experimental medicines. The…
Do you ever look at the labels of the prescription medications you take? Or do you simply rely on your physician to read them to understand the medications’ appropriate uses and side effects? Either way, there’s a good chance that these labels — the detailed instructions for use that accompany every drug approved by the…
In an article published Thursday in the New England Journal of Medicine, two top officials from the US Food and Drug Administration (FDA) say that “master protocols” for studies involving multiple drugs or multiple diseases (or both) simultaneously are needed to efficiently generate evidence for precision medicines. “The standard approach to generating this evidence—a…
High-quality evidence is what we use to guide medical practice. The standard approach to generating this evidence — a series of clinical trials, each investigating one or two interventions in a single disease — has become ever more expensive and challenging to execute. As a result, important clinical questions go unanswered. The conduct of “precision…
Executive Summary Basket trials are building a path for tissue-agnostic drug development in oncology, and plans are proceeding for more master protocols in pediatric cancers, acute myeloid leukemia and pancreatic cancer. Master protocol trial designs are slowly gaining ground, especially in oncology development, as results have emerged from the early generation of basket and…
Executive Summary Center for Drug Evaluation and Research Director Janet Woodcock continues to promote innovation in clinical trial design with a review of master protocols in the New England Journal of Medicine. FDA trumpeted its support for novel clinical trial designs using master protocols with a review article in the New England Journal of…
HHS will be able to transfer funds to FDA’s Oncology Center of Excellence thanks to language included in the House Appropriations Committee’s fiscal 2018 agriculture appropriations bill released Tuesday (June 27). Inside Health Policy had previously reported that FDA was using its existing funding to support OCE, and that the agency and the National Institutes…
Amid proposed federal government budget cuts, more than 250 cancer researchers, medical professionals, policymakers, patients, caregivers, survivors, and advocates will convene in Washington, D.C. today for Cancer Moonshot: One Year Later. The Summit is jointly hosted by seven of the leading cancer organizations: Cancer Support Community (CSC), American Cancer Society Cancer Action Network (ACS CAN), CancerCare,…
