Pre-clinical Studies - Answers purpose is to determine safe starting dose for humans
Folic Acid - Answers Positive effect on kids w/ lymphoblastic leukemia
Clinical trials - Answers comparing 2+ therapeutic tx in ctl setting to evaluate effect of intervention of
specific disease/s
Clinical Trial phase 1 - Answers how much can you handle before breakdown?
determine max tolerated dose of drug or drug combo.
ID dose-limiting toxicities: highest dose for which incidence of dose limiting toxicities is <33%
Clinical Trial Phase 1 Patient - Answers advanced disease, good organ function, resistant to standard
therapies
Clinical Trial phase 2 - Answers determines efficacy of new agent in tx of specific cancer types and
validate toxicity & dosage data. info r/t drug administration, acute toxicity, & supporting care
Clinical Trial phase 2 Patient - Answers pt who show little to no response to prior tx usually selected w/
normal organ function, measurable tumor size, reasonable life expectancy & functional status.
Includes pt who have not been treated w/ investigational drug
Clinical Trial Phase 3 - Answers determine value of agent r/t existing tx. Measure response, toxicity,
survival & QOL
Clinical trial Phase 3 Patient - Answers large number of newly dx who receive tx and observed over long
period of time
Clinical Trial Phase 4 - Answers Occurs after agent is available in commercial market. Efforts to decrease
AE, toxicity w/ acceptable cure rate. Focuses more on long term safety
Institutional Review Board - Answers Ensures the rights/welfare of humans are protected, by signing
informed consent and requires documentation of eligibility, tx, modifications, toxicities, and outcome
informed consent - Answers requires enough information to make decisions consistent w/ cultural,
spiritual, & psychosocial values.
purpose/duration/procedures, participant rights, possible benefits, probable risks, alternative therapies,
confidentiality stmt, stmt for voluntary participation
nursing role - Answers verify consent, information provided, educational materials, radiographic/lab
studies completed prior to tx, dose/schedule, drug rx, collect lab specimens, document start/stop times,
pt response, instruct family to report rx