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…
Vice President Joe Biden called on cancer researchers and health organizations to set aside individual goals in treatment and research to work together on fighting the second-leading cause of death in the U.S. Advances against the disease that kills more than half a million Americans every year will come faster if doctors, researchers and groups…
A Visual Explanation of the Collective Efforts Against Cancer: Past, Present, and Potential Future Breakthroughs Genentech recently published a groundbreaking visual explanation focusing on recent medical breakthroughs in the fight to end cancer. Highlighted in this rich history is Friends of Cancer Research (Friends) chairperson and founder, Ellen Sigal, for her contribution as a patient advocate and…
The time is right for the FDA to reorganize in a stepwise, structural, disease-oriented manner to align its regulatory science with major advances in medicine, according to a panel at a Senate briefing on Capitol Hill. At a meeting sponsored by the advocacy group Friends of Cancer Research (FOCR), speakers discussed the FOCR’s concept of…
ASCO and Friends of Cancer Research have launched a collaborative effort to modernize eligibility criteria to promote greater patient participation in cancer clinical trials. Eligibility criteria are standards that determine who can participate in a particular trial and often exclude individuals based on characteristics such as type and stage of disease, previous treatment history, age,…
Friends of Cancer Research (Friends) and the U.S. Food and Drug Administration (FDA) have been working together for many years on an idea known as breakthrough therapy, and it has produced results beyond anyone’s hopes. Said Ellen Sigal, PhD, Friends Chair and Founder, “When we were first talking about what the breakthrough designation could do,…
