All posts tagged: Clinical Trials

Guest Blog–New FDA Draft Guidance Aims to Protect Children who Participate in Clinical Trials

November 5, 2022
Community News, Guest Blogs No comments yet

The U.S. Food and Drug Administration issued a draft guidance that, when finalized, will provide the agency’s perspective on the ethical considerations for including and protecting children in clinical trials. The draft guidance is intended to assist industry, sponsors and institutional review boards (IRBs) when considering the enrollment of children in clinical investigations of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 Webinar–20 Years of Neuroblastoma Research Progress

November 11, 2020
Webinars No comments yet
Have you wondered what has driven the progress in treating relapsed and refectory neuroblastoma patients?  If so, you may be interested in watching our November All-Member Webinar.  CAC2 Member Gavin Lindberg (EVAN Foundation) hosted a speaker program that included Drs. Kate Matthay, Judy Villablanca, and Steve DuBois speaking on:  20 Years of Neuroblastoma Research Progress. These leaders of the New Approaches to Neuroblastoma Therapy (NANT) consortium informed the audience about the progress and challenges associated with developing new strategies for refractory and relapsed neuroblastoma patients. We also learned about the history of this 20 year-old, multi-institution network, their collaborations with the Children’s [...] Read more

CAC2 Webinar–The Art and Science of Navigating the Clinical Trials Landscape for Childhood Cancer

June 18, 2020
Webinars No comments yet
Our June CAC2 All-Member webinar explored the world of clinical trials and helped us understand the important role of clinical trial navigation, a topic that is growing in importance as the number and variety of options for pediatric and adolescent oncology patients has begun to grow. Brenna Carswell, Clinical Trials Navigator at Alex’s Lemonade Stand Foundation, and Michael Wenger, Vice President of Patient Engagement at Trialscope, covered the basic trends in trial enrollment and the challenges and solutions to improving access to clinical trials for children and teens with cancer.  Both Brenna and Michael are cancer survivors! Read more

CAC2 Webinar–What is a Pediatric Study Plan?

May 27, 2020
Webinars No comments yet
Our May CAC2 All-Member webinar focused on how pediatric cancer study plans are developed.  CAC2 Member Kelli Wright (CureSearch) introduced Dr. Brenda Weigel from University of Minnesota’s Masonic Cancer Center and Dr. Samuel Blackman of Day One Biopharmaceuticals as they addressed: What is a Pediatric Study Plan (PSP)? How is it created and by who? How does FDARA/RACE for Children impact PSP development? Where in the process are the opportunities to create better PSPs? Currently, regulatory agencies require that a pharmaceutical or biotechnology company submit a Pediatric Study Plan (PSP) to confirm the suitability of drug usage in the pediatric [...] Read more

Phase III Pediatric Brain Tumor Clinical Trial Collaboration

May 3, 2020
Collaborative Achievements No comments yet
Everybody is worried these days.  We have witnessed toilet paper hoarding and other behaviors that make us feel vulnerable and alone.  That's why we would like to hold up and highlight some fabulous Member Collaborations.   One recent collaboration between two CAC2 members really brings this story of hope in the midst of worry during Coronavirus as these two organizations, The Taylor Matthews Foundation and the Pediatric Brain Tumor Foundation found a way to support funding for a Phase III clinical trial. Here's the story in their words: "As you may recall, The Taylor Matthews Foundation first linked arms with PBTF [...] Read more

CAC2 Webinar–Collaboration and Progress: How Target Pediatric AML Facilitated LLS PedAL, a Global Master Trial in Acute Leukemia

October 2, 2019
Webinars No comments yet
In our October All-Member Webinar, TpAML co-founder/advocate Julie Guillot and Dr. Gwen Nichols, Chief Medical Officer, Leukemia & Lymphoma Society, highlighted the energy and work behind putting -- and keeping -- the patient at the center of drug development. Participants had the opportunity to learn valuable insights on the makings of Target Pediatric AML (that a number of CAC2 members worked together on) and how research findings have spurred the launch of a groundbreaking global master clinical trial initiative in high-risk childhood leukemia, LLS PedAL. Read more

CAC2 Webinar–Understanding and Enhancing the Role of Children with Cancer and their Parents in Pediatric Oncology Drug Development

August 15, 2018
Webinars No comments yet
This month's webinar was presented by Stacy Crane, Predoctoral Fellow at Indiana University School of Nursing.  She described the experience of participating in a Phase I clinical trial from the perspective of the parents of children battling cancer. While overall, parents do not regret their child participating in a phase I clinical trial and would recommend participation to other parents of children with cancer, there are implications for clinicians and researchers who work with children with cancer and their families. One way to improve experiences in early phase clinical trial participation is to ensure that the side effects that impact the patients during these [...] Read more

CAC2 Webinar–A Personalized Precision Approach to Therapy for Neuroblastoma

May 26, 2017
Webinars No comments yet
In this May's All-Member and Community Webinar, Gavin Lindberg (The EVAN Foundation) hosted physician investigators from the New Approaches to Neuroblastoma Therapy (NANT) clinical trials consortium who presented their work on defining genetic and biologic changes in a patient’s specific tumor that can be used to guide the development of novel more effective therapies, and the choice of therapy for an individual patient. They also discussed the implications of this approach to pediatric cancer in general. Dr. Shahab Asgharzadeh presented about New Approaches to Neuroblastoma Therapy (NANT) Precision Medicine Trial, identifying biomarkers for targeted and immune based therapies. Dr. Asgharzadeh [...] Read more

CAC2 Webinar–Basics of a Clinical Trial in Pediatrics: A Sponsor’s Perspective

August 19, 2016
Webinars No comments yet
In this All-Member and all-community webinar for August 2016, CAC2 welcomes Drs. Michael Trigg, Brigid Bradley-Garelik, and Greg Plautz from Bristol-Myers Squib, speaking on the clinical trial process. These three esteemed industry experts provided an overview of the clinical trial process, particularly from an industry-sponsored trial perspective and cover topics such as clinical trial designs, different required FDA phases of drug development, data monitoring committees, general principles of pediatric trials and special considerations of pediatric trials, industry obligations to pediatrics and personalized medicine. This presentation was not recorded. Read more

CAC2 Webinar–Incorporating Genomics into Pediatric Cancer Trials

March 24, 2015
Webinars No comments yet
During our March All-Member and Community webinar, our guests discussed the findings and outcomes of the February NCI scientific workshop dedicated to childhood cancer genomics. On February 4 and 5, the National Cancer Institute hosted a scientific workshop focused on childhood cancer genomics. Scientist and researchers from around the world met to discuss the state of genomics research in pediatric cancer and what opportunities exist for research going forward. The Coalition Against Childhood Cancer and the Alliance for Childhood Cancer co-hosted this debriefing webinar featuring workshop attendees, Dr. Greg Aune (NCI-NCRA, pediatric oncologist-UTSA, and pediatric cancer survivor), Susan Weiner (Children’s Cause for [...] Read more
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