4 major Peds Coopoerative groups for peds oncology clinical trials. What do they stand for?
CCG,POG,NTWS, and IRSG
Children’s Cancer Group, Pediatric Oncology Group, National Wilms Tumor Study Group, and Intergroup Rhabdomyosarcoma Group. They all merged into COG
Initial trial of a new agent in humans - study PK and eval toxicities and max dose. Unlikely to have a long-term positive effect for patient. Which phase?
This phase determines efficacy of treatment in a specific disease and further evals safety/toxicity
Phase II. pt must have a tumor that is measurable to eval effectiveness.
This phase is most common in peds onc. Used to compare new treatment to standard treatment on a larger scale. Includes randomizations and stratification so every subject has equal chance of being assigned to each treatment.
This phase is large scale to approve agent for widespread use. Rarely used in peds onc.
When does informed consent happen?
it is an ongoing process.
What is the TDM?
Therapy delivery roadmap. aka roadmap.
What is the usual age for obtaining assent?
7yo is the minumum