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February 23, 2021
September 29, 2023
Fulfills agency promise after bill failed to pass last year Move faces opposition from lab groups, academic centers The FDA would have clear authority to regulate medical tests that come from a single laboratory under a proposal released by the agency Friday. The proposed rule (RIN: 0910-AI85) marks a pivotal step in the Food and…
Learn MoreSeptember 29, 2023
Brittany Avin McKelvey noticed something was wrong when she had trouble yelling plays to her teammates during middle school basketball games. Eventually, she could not raise her voice so friends could hear her in the school cafeteria. Her doctor told her to rest her voice. When her voice didn’t return after months of rest, an…
Learn MoreSeptember 22, 2023
The biomarker-driven Lung Cancer Master Protocol (Lung-MAP) may have enrolled a higher percentage of patients who are older, are from rural or socioeconomically deprived areas, and have Medicaid or no insurance compared with conventional, standalone clinical trials in advanced non–small cell lung cancer (NSCLC), according to a study published by Vaidya et al in JCO Precision Oncology.…
Learn MoreSeptember 14, 2023
During this week’s Friends of Cancer Research (FOCR) meeting on the use of real-world data to support oncology drug development, FDA Commissioner Robert Califf shared his take on the barriers preventing the collection and utilization of high-quality real-world data (RWD) and pondered what lessons the U.S. healthcare system could stand to learn from others. The…
Learn MoreSeptember 13, 2023
The “biggest area” where FDA Commissioner Rob Califf believes real-world evidence will “make a difference” is in the post-market phase, “where there are all kinds of issues that often involve other parts of the ecosystem.” He pointed to drug developers’ new focus on Alzheimer’s disease and obesity: “we’ve got these enormous markets” and significant patient…
Learn MoreSeptember 8, 2023
As compared to conventional, stand-alone clinical trials in advanced non-small cell lung cancer (NSCLC), the biomarker-driven Lung Cancer Master Protocol (Lung-MAP) has enrolled higher percentages of patients who are older, patients who are from rural or socioeconomically deprived areas, and patients who have Medicaid or no insurance. These are some of the results of an…
Learn MoreSeptember 6, 2023
Area of concern for oncology researchers must be addressed so trials can reflect a more accurate real-world population. At Pharma 2023 this past spring, Dirk Reitsma, MD, senior vice president, therapeutic area head of oncology, medical, and scientific strategy for PPD, part of Thermo Fisher Scientific, presented “Inclusivity in Oncology Clinical Trials.” With the many…
Learn MoreSeptember 1, 2023
GODFREY— It’s been 10 years since the late Theresa Newby Harpole founded Theresa’s Research Foundation. Though she lost her fight with metastatic breast cancer at age 46, foundation members say there is plenty to celebrate and she would be proud. Theresa’s Research Foundation’s authoritative research has been published in a white paper titled “Continuing to…
Learn MoreAugust 31, 2023
Stakeholders prepare for the U.S. Food and Drug Administration’s (“FDA”) rulemaking effort to “make explicit” that laboratory developed tests (“LDTs”) are devices subject to the agency’s oversight, reigniting outstanding questions of jurisdiction and authority. The Office of Management and Budget’s Office of Information and Regulatory Affairs (“OIRA”) recently received a proposed rulemaking from FDA to regulate LDTs…
Learn MoreAugust 21, 2023
GODFREY, Ill., Aug. 21, 2023 /PRNewswire/ — Theresa’s Research Foundation is excited to announce a new White Paper titled “Continuing to Improve the Odds Together: Next Steps for Engaging Researchers and Advocates.” An appreciation for the value of including the patient advocate voice in cancer research has increased in recent years, however, research scientists and patient advocates are often uncertain…
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