The U.S. Food and Drug Administration issued a draft guidance that, when finalized, will provide the agency’s perspective on the ethical considerations for including and protecting children in clinical trials. The draft guidance is intended to assist industry, sponsors and institutional review boards (IRBs) when considering the enrollment of children in clinical investigations of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 […]
Read moreAssorted News from the Last Week: Supporting Children and Families Through a Cancer Diagnosis by Child Life Specialist Nicolle Bengtson. Nearly 20 years since her initial diagnosis, CAC2 Member Juanita Prada now works with children who are fighting cancer just like she did. Day One Biopharmaceuticals emerged in May to develop new drugs specifically for children with cancer. Now, as it ramps up its work, the company is making a flurry of new hires and new board appointments, including a new CEO: Jeremy Bender, Ph.D., who previously led corporate development at Gilead Sciences. Challenges burden pediatric oncologists following the peak […]
Read moreAssorted News from the Last Two Weeks: National Cancer Institute’s CCDI Molecular Characterization Initiative adds rare tumors. Study provides first in-depth look at major mix-ups in the genomic terrain of pediatric high-grade gliomas. LLS is working to change the pediatric clinical trial model. The aftermath of childhood cancer: 2000 days without Ana Biden appoints former government scientist as first leader of ARPA-H. The use of tisagenlecleucel (Kymriah) in children younger than 3 years of age with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) was as effective, and safe, in a retrospective cohort study as it was previously seen to […]
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