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Flashcards in 10 Research and Treatment Protocols Deck (8)
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1
Q

4 major Peds Coopoerative groups for peds oncology clinical trials. What do they stand for?
CCG,POG,NTWS, and IRSG

A

Children’s Cancer Group, Pediatric Oncology Group, National Wilms Tumor Study Group, and Intergroup Rhabdomyosarcoma Group. They all merged into COG

2
Q

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?

A

Phase I

3
Q

This phase determines efficacy of treatment in a specific disease and further evals safety/toxicity

A

Phase II. pt must have a tumor that is measurable to eval effectiveness.

4
Q

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.

A

Phase III.

5
Q

This phase is large scale to approve agent for widespread use. Rarely used in peds onc.

A

Phase IV.

6
Q

When does informed consent happen?

A

it is an ongoing process.

7
Q

What is the TDM?

A

Therapy delivery roadmap. aka roadmap.

8
Q

What is the usual age for obtaining assent?

A

7yo is the minumum