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What are clinical trials usually about?
answer specific medical question about therapeutic effect of a specific treatment
What does the protocol serve as in clinical trials?
- comprehensive document that guides treatment managment
How many phases are clinical trials divided into?
4 phases - each have unique purpose & general characteristics
What is the goal of a Phase 1 clinical trial?
- Determine maximum tolerated dose (MTD) of an investigational agent or combination of agents
- strict administration schedule
What is the starting dose of the investigational agents used in Phase 1 studies?
dose for children is 80% of the MTD for adults
What patient demographics are common in Phase 1 trial recipients?
- Small trial
- 15-25 patients
- refractory cancer not responsive to other treatment
What other requirements must a patient meet in order to be entered into a Phase 1 trial?
- must have adequate organ function
- reasonable life expectancy
- ability to function in life
- all standard therapeutic options for curative treatment must have been exhausted
What are some common reasons that families consent to Phase 1 clinical trials?
- possible cure
- disease response
- control of symptoms
- help others by contributing to research
What are Phase II clinical trials designed to evaluate?
- efficacy of a new agent in treating specific type of cancer
Phase II clinical trials are disease specific and based on what?
1. biochemical data, pharm data, or both
2. preclinical screening in humor tumor cell lines
3. a suggestion of agent's antitumor activity in Phase 1 trials
What are the patient requirements to be entered into a Phase II clinical trial?
- measurable disease
- normal major organ function
- reasonable life expectancy
- functional status
What patients are the best patient's for Phase II trials?
those who have not already received intensive treatment
How is the sample size for Phase II clinical trials determined?
- based on # of patients needed to allow meaningful statistical conclusions to be drawn about treatment
What should the sample size protect against in Phase II trials?
- minimize chance that a potentially ineffective drug be accepted
- minimize chance that effective drug will be rejected
When can Phase I and Phase II trials be combined into a pilot study?
when clinical trials are used to evaluate a treatment regimen rather than specific agent
What are Phase III trials used to assess?
- the role of a new treatment in terms of overall response, survival, QOL of newly diagnosed patients w/specific diagnosis
What is the goal of a Phase III trial?
- to determine whether the treatment is equivalent with or superio to current or standard treatment
What is a key element of Phase III trials?
- randomization between experimental group & control group (avoids bias)
- stratification by specific prognostic factors
Why are Phase III trials usually implemented at a number of institutions or through cooperative groups?
They require a large number of patients
What are Phase IV clinical trials used for?
- further investigate the long-term safety & efficacy of a treatment
When are Phase IV trials usually implemented?
after the new treatment is approved for standard use
What is the goal of a Phase IV clinical trial?
- decrease side effects
- decrease toxicities
- decrease late effects of treatment
* all while continuing to provide acceptable cure rates
Are Phase IV trials common in pediatric oncology patients?
No
What must followed in order to conduct clinical research trials?
Federal guidelines by US FDA
There are 4 FDA guidelines on page 75 - in brief summary they are...
1. Need IRB approval for human subjects
2. Informed consent must be obtained, & signed
3. Pt's med records should show eligibility requirements are met
4. Strict record keeping when investigational drugs are being used
What 2 nursing assessments should be made when a patient is to begin a clinical trial?
1. ensure patient eligibility & consents are signed
2. ensure safe administration of drugs or therapies
Nursing interventions for patients on clinical trials are the following...
1. Advocate for patient & family
2. Provide support
3. Provide education