January 2, 2019
February 23, 2021
December 8, 2023
The US Food and Drug Administration and National Cancer Institute are collaborating to incubate clinical trial system improvements in an expansion of the partnership between the agencies. Monica Bertagnolli, who had been NCI director before recently being confirmed as National Institutes of Health director, said the “think tank” grew out of an idea discussed last…
Read MoreDecember 6, 2023
The stomach pain stopped Vickie-Lee Wall in her tracks. “The first time the pain got that bad, I honestly thought something had burst in my gut,” said the 64-year-old New Jersey woman, who has stage 4 lobular breast cancer. Her oncologist had prescribed two drugs, including a targeted medication called abemaciclib, after the cancer spread…
Read MoreDecember 5, 2023
The unique public-private partnership that undergirded the Lung-MAP trial for almost a decade may serve as a model for future clinical research that is more rapid, innovative, and inclusive, according to a recent report published by Herbst et al in Clinical Cancer Research. Background The Lung-MAP trial was the first National Cancer Institute (NCI)-sponsored precision medicine clinical…
Read MoreNovember 30, 2023
Payers should be asking how they can help answer clinical research questions, along with industry, and other stakeholders, US Food and Drug Administration Commissioner Robert Califf said. During the Friends of Cancer Research Annual Meeting, Califf suggested that private payers, as well as the Centers for Medicare and Medicaid Services, could use their leverage in…
Read MoreNovember 26, 2023
Oncology drug developers should gather patient-reported outcomes (PROs) as part of their efforts to optimize dosing in early development, a Friends of Cancer Research white paper recommends. FOCR released the white paper in conjunction with its annual meeting this month. It was developed by a group of industry, academic, patient and regulatory participants as part of the…
Read MoreNovember 20, 2023
The current class of oncology drug approvals may not be the best example of the US Food and Drug Administration’s evolving approach to dose optimization policy. Agency officials began pushing oncology sponsors more than a year ago to change from looking for the maximum tolerated dose to finding the optimal dose prior to approval. Because…
Read MoreNovember 17, 2023
A key focus for new National Institutes of Health (NIH) Director Monica Bertagnolli is spearheading innovative way to get more patients into in clinical trials to improve evidence generation, she said in recent remarks, including by getting providers more involved in trial enrollment. Her remarks are in line with calls by the non-profit Reagan-Udall Foundation…
Read MoreNovember 15, 2023
What’s New? This week, Friends of Cancer Research (FOCR) hosted its 2023 annual meeting. The agenda featured three substantive sessions on topics FDA has been focused on for the past year: dose selection in early clinical studies, evaluating the use of oncology products in real-life versus in a controlled research setting, and how real-world data can be…
Read MoreNovember 15, 2023
What’s New? Yesterday, Friends of Cancer Research (FOCR) hosted its 2023 annual meeting. The agenda featured three substantive sessions on topics FDA has been focused on for the past year including dose selection in early clinical studies, evaluating the use of oncology products in real-life versus in a controlled research setting, and how real-world data can be…
Read MoreNovember 15, 2023
A US Food and Drug Administration advisory committee review of two Acrotech Biopharma LLC accelerated approval drugs with long-overdue confirmatory trial requirements may provide the clearest insight yet into how the Oncology Center of Excellence interprets the “due diligence” requirement for such studies and how sponsors’ planning and implementation strategies may factor into this determination. The Oncologic…
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