The Fit for Filing Group at ACCELERATE

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 […]

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CAC2 Childhood Cancer Community News Digest (October 31-November 6)

Assorted News from the Last Week: November is National Family Caregivers Month.  The President Joe Biden honored family caregivers for all they do for the nation with a Presidential Proclamation. "No one should have to choose between a paycheck and looking after a loved one. My Administration is committed to easing that squeeze on working families and getting caregivers the resources and respect they deserve. The Department of Health and Human Services’ National Strategy to Support Family Caregivers outlines nearly 350 actions the Federal Government can take to support family caregivers’ health, well-being, and financial security. Our American Rescue Plan [...] Read more

Guest Blog–New FDA Draft Guidance Aims to Protect Children who Participate in Clinical Trials

The U.S. Food and Drug Administration issued a draft guidance that, when finalized, will provide the agency’s perspective on the ethical considerations for including and protecting children in clinical trials. The draft guidance is intended to assist industry, sponsors and institutional review boards (IRBs) when considering the enrollment of children in clinical investigations of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 […]

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CAC2 Childhood Cancer Community News Digest (October 24-30)

Assorted News from the Last Week: CBS "Sunday Morning" contributor Kelefa Sanneh talked with CAC2 Members Kari and Tom Whitehead and their daughter Emily about how they defeated her cancer and were joined by Dr. Siddhartha Mukherjee, a leading cancer specialist and author of the new book, "The Song of the Cell: An Exploration of Medicine and the New Human." CAC2 Member Cindy Campbell and her family spoke with NBC News’ Tom Llamas to tell the story of how the Campbell family has spent the past decade honoring their son’s life and legacy through a foundation in his name to raise [...] Read more

CAC2 Childhood Cancer Community News Digest (October 17-23)

Assorted 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 […]

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CAC2 Childhood Cancer Community News Digest (October 10-16)

Assorted News from the Last Week: Pedmark (sodium thiosulfate) is now available to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, nonmetastatic solid tumors. Pediatric patients with cancer and those who have undergone hematopoietic stem cell transplant (HSCT) may develop long-term effects, including fatigue. However, fatigue is not associated with treatment intensity or therapy type, according to findings published in the Journal of Child Health Care. Real-world costs for care for commercially insured U.S. pediatric patients with acute lymphoblastic leukemia (ALL) were higher in those diagnosed at age 10 [...] Read more

CAC2 Childhood Cancer Community News Digest (October 3-9)

Assorted 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 […]

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CAC2 Childhood Cancer Community News Digest (September 26-October 2)

Assorted News from the Last Week: Making transformative advances against childhood cancer:  A conversation with Dr. Doug Hawkins 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. Gift from a Child/Swifty highlighted on ABC News Chicago.  With further coverage here. Financial hardship in adult survivors of childhood cancer in the era after implementation of the affordable care act:  A report from the Childhood Cancer Survivor Study Upcoming Webinars, [...] Read more

CAC2 Childhood Cancer Community News Digest (September 19-25)

Assorted 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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CAC2 Childhood Cancer Community News Digest (September 12-18)

Assorted 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 […]

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