Executive Summary Rigorous planning and a multidisciplinary team including database experts and healthcare specialists with local knowledge are vital to effective real-world evidence, white paper shows. “Real-world database studies are a long journey,” IQVIA Real World Solutions UK associate principal Paola Nasuti observed in an interview with the Pink Sheet. “The data sciences…
On November 20, 2019, Stephen Hahn, MD, President Trump’s nominee to be the next Commissioner of the U.S. Food and Drug Administration (FDA), appeared before the Senate Health, Education, Labor, and Pension Committee and answered wide-ranging questions relating to the many important roles the Commissioner must oversee. In a statement released by Friends of Cancer…
Friends of Cancer Research (Friends) recently announced the launch of its latest project, ctMoniTR. This pilot project will aim to harmonize the use of circulating tumor DNA (ctDNA) to monitor treatment response in patients with cancer and test the feasibility of data comparison from different clinical studies. Friends is pleased to partner with various…
Tumor mutational burden (TMB) has generated interest as a potential biomarker of response to immunotherapy and has already been examined in the context of several lung cancer trials to gauge its utility. One such analysis, which was presented at the 2019 European Society of Medical Oncology (ESMO) Congress, explored the association between tissue TMB…
The US Food and Drug Administration (FDA) may expand a pilot project that allows for simultaneous drug approval decisions from US, Canadian and Australian regulators to include Singapore and Switzerland, Richard Pazdur, director of FDA’s Oncology Center of Excellence, said Tuesday at the Friends of Cancer Research’s annual meeting in Washington, DC. If Singapore…
The number of expedited FDA approvals for cancer drugs that are based on surrogate end points is increasing, leading many to search for new ways to uncover efficacy and safety data to justify the costs associated with these treatments. With the growth of data innovations and collaborations, the answer might be found in real-world evidence…
Sudip Parikh has helped shape U.S. science policy as a staffer on a powerful congressional spending panel. He’s been a senior health care executive for a large nonprofit organization that manages several federal research facilities. And in January 2020, the 46-year-old structural biologist will become the new CEO of AAAS (which publishes Science) as the…
On September 24, 2019, Friends of Cancer Research (Friends) hosted its 23rd Annual Cancer Leadership Awards Reception. The event honored individuals who have been champions of cancer research and steadfast advocates for patients: Anna Barker, MA, PhD, Professor and Director, Transformative Healthcare Networks, Arizona State University, who was awarded this year’s Ellen V. Sigal Advocacy…
Edward S. Kim, MD, chair, Department of Solid Tumor Oncology, Levine Cancer Institute, discusses clinical trial eligibility criteria in lung cancer. Kim led a task force that evaluated the impact of eligibility criteria on clinical trial enrollment and found that if there were less than 27 eligibility criteria, the trial had a higher likelihood…
