NEW YORK – Hoping to keep up with an increasing number of clinical assays for DNA repair deficiency, nonprofit Friends of Cancer Research is midway through a project aimed at harmonizing existing tests and developing best practices for new entrants. Hillary Stires, FOCR’s director of regulatory and research partnerships, presented early data from the group’s…
Many contemporary clinical trials for metastatic renal cell carcinoma incorporate restrictive eligibility criteria, according to study results. “For instance, HIV positivity, as well as hepatitis B and C positivity, were commonly cited exclusion criteria despite limited evidence that these criteria significantly impact clinical outcomes,” Daniela V. Castro, MS, clinical research associate in medical oncology at City of…
After skin cancer, breast cancer is the most common cancer among women in the U.S. Although deaths from the disease have been declining over the years, thanks to increased awareness and detection and earlier screening, Black women have benefited from this trend far less than white women. The “mortality gap” between Black and white women is stark,…
The US Food & Drug Administration’s vaccine review operations are still not close to returning to pre-pandemic levels of operations, Center for Biologics Evaluation & Research Director Peter Marks said during a Reagan-Udall Foundation/Friends of Cancer Research event. “In the area of vaccines, we are still very much under a very large load of work,”…
Lab results inform the majority of healthcare decisions, which is why patients relying on these tests need assurance that diagnostic outcomes are accurate. At the same time, diagnostics are becoming ever more complex with the rapid advancement of technology. This is why a modern regulatory framework that sets a uniform standard for diagnostics is needed,…
Circulating tumor DNA (ctDNA) is associated with outcomes in patients with non–small cell lung cancer (NSCLC) treated with an immune checkpoint inhibitor (ICI), according to the results of a pooled analysis of 5 studies. “Our study provides supporting evidence that ctDNA may serve as an early predictor of treatment response,” the study authors, led…
Improving diversity in cancer clinical trial enrollment has become an increased priority among oncology researchers. However, strict exclusion and inclusion criteria in these trials have become a major barrier to patient access, limiting generalizability of trial results. “There is widespread recognition that cancer clinical trial accrual remains a persistent challenge,” David E. Gerber, MD, associate director of clinical…
Background: The FDA’s recent work on biomarker development and qualification A biomarker, according to the FDA, is “a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions.” Some examples of biomarkers include blood values of a given chemical or protein, imaging values…
INSTEAD OF STARTING HER SOPHOMORE YEAR of high school in fall 2013, Lauren Telesz spent most of the term in Yale New Haven Children’s Hospital in Connecticut, receiving chemotherapy for stage IV Hodgkin lymphoma. Besides facing the challenges of cancer itself, the 15-year-old felt isolated. Her friends from school were heading to the homecoming dance while…
For results from cancer clinical trials to be more generalizable to the real world, there needs to be some loosening of exclusion criteria, say researchers. A new study concludes that the National Cancer Institute (NCI) is making some headway in its efforts to do this, but the study also shows potential challenges. “Exclusion of patients…
