Blogged with permission and thanks by the ACCELERATE Fit for Filing Working Group The ACCELERATE PLATFORM’S Fit for Filing (FFF) group was formed in 2019 to explore the issues of academic-led trials that typically do not produce data that is fit-for-filing to gain marketing approval by regulatory agencies. The scope of Fit for Filing (FFF) is to develop best principles on how to design and deliver an academic or academic & industry collaborative trial with a dataset that can be included in a package for regulatory filing.Objectives of the FFF working group are: Define the barriers and propose solutions to ensure […]
Read moreThe U.S. Food and Drug Administration issued a draft guidance that, when finalized, will provide the agency’s perspective on the ethical considerations for including and protecting children in clinical trials. The draft guidance is intended to assist industry, sponsors and institutional review boards (IRBs) when considering the enrollment of children in clinical investigations of drugs, biological products and medical devices. “Children need access to safe and effective medical products and health care professionals need data to make evidence-based decisions when treating children. However, children are a vulnerable population who can’t provide consent for themselves and are afforded additional safeguards when participating in […]
Read moreAssorted News from the Last Week: Nearly one in four families of pediatric patients with acute lymphoblastic leukemia (ALL) enrolled in a clinical trial experienced food insecurity, and almost half of the families eligible for the Supplemental Nutrition Assistance Program (SNAP) did not receive benefits. In addition, receiving SNAP benefits was not sufficient to address food insecurity. Patients who undergo radiotherapy for the treatment of childhood cancer have an increased risk of developing meningioma later in life, and that risk may persist for 30 years, according to a case-control study published in JAMA Oncology. The incidence of invasive breast cancer […]
Read moreAssorted News from the Last Week: Helping kids manage fear and anxiety when they have a serious illness Public sharing of pediatric brain cancer presentation prepared for House Health Subcommittee supporting H. Res. 404 New findings show more than 32,000 newly diagnosed adolescent and young adult (AYA) cancer patients may lose or face compromised fertility preservation care each year due to legislation that has been enacted or is expected to be enacted in some states. Despite decades of medical advances, children who develop the pediatric eye cancer retinoblastoma often lose their vision or an eye due to a lack of […]
Read moreAssorted News from the Last Week: The FDA has approved sodium thiosulfate (Pedmark) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients aged 1 month and older with localized, nonmetastatic solid tumors. The White House announced its support for the Childhood Cancer STAR Reauthorization Act. Answers to common questions about COVID-19 vaccines in children with cancer Cancer in kids tied to prenatal exposure to high-dose folic acid and seizure meds, but no link seen among children of mothers without epilepsy. Scientists have found that group 3 and 4 medulloblastoma arise from the rhombic lip, knowledge that may […]
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