Results for 'childhood cancer'
Meena N Murugappan, PharmD, MPH, PhD(c), Bellinda L King-Kallimanis, PhD, Gregory H Reaman, MD, Vishal Bhatnagar, MD, Erica G Horodniceanu, MPH, Najat Bouchkouj, MD, Paul G Kluetz, MD
Patient-Reported Outcomes in Pediatric Cancer Registration Trials: A US Food and Drug Administration Perspective
cancer, pediatrics, product labeling, united states food and drug administration, childhood cancer, denosumab, surrogate endpoints, adverse event, patient self-report, pediatric oncology, selumetinib, benefit-risk assessment, tisagenlecleucel, statistica
PROs have been feasible to collect from patients as young as 7 years old and were included in trials from 2013 onward. PROs were used as exploratory endpoints in four product applications but not included in product labeling. To include PRO data in FDA labeling, early interaction with the FDA, c…
Apr 30th • 12 mins read
Thomas J. Hwang, Liat Orenstein, Steven G. DuBois, Katherine A. Janeway, Florence T. Bourgeois
Pediatric Trials for Cancer Therapies With Targets Potentially Relevant to Pediatric Cancers
antineoplastic agents, adult, child, pediatrics, continental population groups, united states food and drug administration, statutes and laws, cancer therapy, childhood cancer, molecular target
The Research to Accelerate Cures and Equity (RACE) for Children Act was enacted in 2017. The Act authorizes the US FDA to require pediatric studies for new cancer drugs with molecular targets relevant to pediatric cancers. An examination of 78 adult cancer drugs approved by the FDA from 2007 to …
Oct 29th • 10 mins read
Siddharth Agrawal, Nidhi Bansal
Advances and Challenges in Pediatric and Childhood Cancers
CNS, central nervous system, ES, Ewing sarcoma, MB, medulloblastoma, PTSD, post traumatic stress disorder, RB, retinoblastoma
Pediatric cancers, while uncommon compared to adult cancers, include leukemia, CNS tumors, lymphoma, Wilms' tumor, and retinoblastoma. Challenges in pediatric cancer treatment encompass late diagnosis, varied immune responses, preserving fertility, minimizing late effects, and considering lo…
Jun 27th • 2 mins read
Jaques van Heerden, MD, Mohamed Zaghloul, MD, Anouk Neven, MSc, Teresa de Rojas, MD, PhD, Jennifer Geel, MD, Catherine Patte, MD, Joyce Balagadde-Kambugu, MD, Peter Hesseling, MD, Francine Tchintseme, MD, Eric Bouffet, MD, and Laila Hessissen, MD
Pediatric Oncology Clinical Trials and Collaborative Research in Africa: Current Landscape and Future Perspectives
pediatric oncology, clinical trials, research, Africa, collaborative research
Current childhood cancer survival rates in African countries range from 8.1% to 30.3%. The review focuses on pediatric oncology trials in Africa, highlighting challenges and suggesting research collaboration opportunities. Data were collected from the SIOP global mapping survey, ClinicalT…
Aug 7th • 10 mins read