Research and Tx Protocols

Question 1

Goals of Clinical Trials

Answer 1

• Determine effectiveness of new treatments
• Maintain patient safety
• Improve outcomes (increase cure rate, decrease toxicity)

Question 2

Basic requirements of clinical trials

Answer 2

• Meet federal regulations
• Obtain IRB approval
• Informed consent from subjects

Question 3

What is the name of the cooperative group merger that formed in 2000?

Answer 3

Children’s oncology group (COG)

Question 4

Advantages of clinical trials include:

Answer 4

• Proven survival advantage for participants

- Improved treatments benefit all patients

Question 5

Preclinical drug development

Answer 5

• Basic lab research

- Preceds use of new drugs in humans (mice)

Question 6

Phase I clinical trial (goals, population)

Answer 6

Goals: determine max tolerated dose, eval toxicities, study PK
Enrollment limited to patients with refractory dz

Question 7

Phase II clinical trial (goals)

Answer 7

• Determines efficacy of a treatment in a specific disease (requires measurable disease response, evals one (or combo) of agents
• Further defines safety and toxicity profile

Question 8

Phase III clinical trial

Answer 8

• Compares effectiveness of new to standard
• Randomization used to eliminate bias
• Stratifcation assurances blaanced representation of subjects in all tx regimens (gender, age)

Question 9

Phase IV clinical trial

Answer 9

Further eval approved tx for:

• Efficacy
• Cost
• Impact on QOL
• Rare in peds onc

Question 10

Principal investigator

Answer 10

Person responsible for design and/or conduct of the research study

Question 11

Institutional Review Board

Answer 11

Multidisciplinary panel at health care facility that reviews and approves research protocols

Provides protection for patients participating in clinical trials

Question 12

Clinical research associate

Answer 12

Person responsible for managing data collection and administrative aspects of research study

Question 13

Informed consent

Answer 13

• Process during which a person learns key facts about a clinical trial including risks and benefits
• Includes voluntary decision to participate or decline

Question 14

Eligibility criteria

Answer 14

Patient characteristics required for study entry (type and stafe of cancer, age, prior tx, health status)

It ensures patients are alike in key ways

Question 15

Common protocol phases

Answer 15

• Indution (reduce bulk of CA to a minimum)
• Consolidation/Intensification (detsroy remaining cancer cells, often multi-modal)
• Maintenace (maintain disease-free status and prevent recurrence)

Question 16

What is the name of the summary of the clinical aspects of the protocol?

Answer 16

The therapeutic roadmap