Vice President Biden will convene a day-long cancer summit in Washington on Wednesday that will be part pep rally, part Ted talk, part wonk-a-thon — all designed to garner support for the Obama administration’s year-long initiative to advance cancer research. The summit, expected to draw as many as 300 people from academia, industry and advocacy…
Executive Summary Industry, patient advocates seek to use data collected outside traditional clinical trials to confirm benefit or broaden labeling, but FDA officials say large drug effects would be needed to overcome ‘noise’ from more loosely structured studies. Breakthrough-type drugs for which effect sizes are expected to be large may provide a potential avenue…
Executive Summary Symptom control, overall survival and time to treatment failure may be more useful measures in a real-world setting than progression-free survival, FDA oncology director Pazdur says. If the biopharma industry wants to rely more on real-world data to support regulatory decision-making, it may need to look at endpoints different from those used…
Executive Summary Under the Information Exchange and Data Transformation initiative, existing clinical trial datasets will be standardized and integrated with real-world sources in a new data environment. FDA’s Office of Hematology and Oncology Products is trying to better leverage the clinical data already in-house while also integrating it with real-world data sources under a…
Executive Summary FDA is close to announcing a new “Oncology Center of Excellence” to consolidate drug, biologic and device review functions in cancer. In the run up to the announcement, CBER has been stressing the need to preserve its culture and experience with novel manufacturing techniques. FDA is moving forward with a “Center of…
CALIFF’S VIEWS: REAL-WORLD DATA IN DRUG APPROVALS — The FDA head said he sees openings for “real-world” evidence in drug development and approvals. Drug makers and some members of Congress have been pushing the topic, as the industry hopes to capitalize on all that data from electronic health records to speed up and reduce the…
The development and approval of more breakthrough therapies based on limited clinical trial data is heightening the need for more efficient methods of documenting treatment benefits in medical practice. At the same time, difficulties in designing and carrying out randomized clinical trials for promising medicines illustrates a need for innovative research strategies. One response is…
Executive Summary Commissioner champions data from randomized clinical practice studies to support benefit/risk decisions but also sees value in other types of data generated outside the traditional clinical trial setting. Randomized clinical trials have long been extolled as the gold standard for establishing drug efficacy and safety. However, FDA Commissioner Robert Califf has his sights…
A group of 28 cancer patient advocacy organizations, including the American Cancer Society and Friends of Cancer Research, pressed FDA to set up a standalone Oncology Center of Excellence that includes drug, biologics and device experts to handle reviews of products designed to treat cancer. Their letter to the agency Monday (June 6) follows a…
House Energy and Commerce Committee Chair Fred Upton (R-MI) and Ranking Member Frank Pallone (D-NJ) introduced legislation Wednesday (June 8) that calls on FDA to establish disease-specific intercenter institutes to streamline the review of of drugs and devices. The bill mirrors language in provisions of the Senate health committee’s innovation legislation. It also follows a…
