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Category: In the News

The ASCO Post – Collaborative Team Receives Funding to Enhance Participation of Black Women in Cancer Clinical Trials

A team of leaders in patient advocacy and education at the Black Women’s Health Imperative, Friends of Cancer Research (Friends), and Stand Up To Cancer (SU2C) have been approved for a funding award through the Eugene Washington Patient-Centered Outcomes Research Institute (PCORI) Engagement Awards (Engagement Awards) program. The funds will support Project TEACH: Trained Empowered…

The Cancer Letter – Lung-MAP: A five-year recap on the first master protocol trial in cancer research

This is a formidable challenge. Cancer trials were, and remain, notoriously time-consuming to launch, expensive to run, and difficult to enroll patients to. A deeper understanding of cancer biology and the genomics revolution in medicine have changed how we approach clinical research.When the Lung-MAP trial was launched in June 2014, the goal was simple: Make…

POLITICO PRO – FDA oncology center moving to broaden cancer trial populations

FDA’s cancer center is working with patient and research groups on guidance to broaden the number of patients eligible to join clinical trials, officials said Wednesday.   The Oncology Center for Excellence is working with Friends of Cancer Research and the American Society of Clinical Oncology on the guidance, which might be released this year…

The Cancer Letter – SU2C initiatives aim to boost diversity in cancer trials

SU2C has developed the procurement language to solicit proposals for SU2C Dream Teams, Research Teams and other grants mechanisms in the SU2C research portfolio to increase diverse participation in cancer clinical trials.   Grant applicants submitted to SU2C will now need to include the following information: An indication of whether the research will address the populations…

Inside Health Policy – E&C Weighs Orphan Drug, Generic Drug Labeling, Manufacturing Reforms

The House Energy & Commerce health panel will review legislative proposals that aim to end gaming of the Orphan Drug Act, improve generic drug labeling and foster continuous manufacturing at a legislative hearing Wednesday (Jan. 29). The bills, which if enacted could help lower drug costs by spurring generic drug competition, are among 10 to…

GenomeWeb – FNIH Team Selects Cancer Biomarkers in Phase I of Liquid Biopsy Reference Standards Project

After officially launching the “Identification and Validation of ctDNA Quality Control Materials” Initiative last fall, a team at the Foundation of the National Institutes of Health (FNIH) has identified 14 clinically actional variants that it will incorporate as part of quality control materials to submit to the US Food and Drug Administration for eventual widespread…

The Cancer Letter – Al Benson named to new role in ECOGACRIN leadership

Al B. Benson III was appointed deputy chair for policy and implementation by the ECOG-ACRIN Cancer Research Group. Benson will lead EA’s efforts to strengthen collaboration between academic and community participants and expand real-world opportunities and community leadership. His expertise in program and guideline development will be critical to the development of a focused, integrated…

Precision Oncology News – In Precision Oncology, Drugs Coming to Market Based on Smaller, Early-Phase, Single-Arm Trials

When the first personalized cancer therapies came to market more than 20 years ago, some experts predicted that the field’s growing understanding of the molecular features driving tumors would alter the way drugs are developed. The oft-cited statistics about drug development is that it takes more than a decade and well over a billion dollars…

Pink Sheet – Richard Pazdur: 20th Anniversary Edition

Executive Summary US FDA oncology chief celebrates his 20th year at the agency with a frank and wide-ranging podcast interview in which he addresses the next (two) phases of the Oncology Center of Excellence, his ‘think it/do it’ mentality, and whether advisory committees still give good advice.   Richard Pazdur is clearly having a lot…

Bloomberg – FDA Drug Approvals Require Less Rigorous Evidence, Study Finds

An ongoing push to speed new medicines to patients has led to the growth of new Food and Drug Administration programs with relaxed evidence standards for approving drugs, according to an analysis from researchers at Harvard Medical School and Brigham and Women’s Hospital.   The findings, released Tuesday, mean patients and their doctors may not…