Block 3 Flashcards
Key word: Max dose
- Look for the max tolerable dose
- Other treatments have failed
- Normal organ function
- Test drugs on a small sample
Phase 1
Describe phase 1
Key word: Max dose
- Look for the max tolerable dose
- Other treatments have failed
- Normal organ function
- Test drugs on a small sample
No therapeutic effects
Phase 0
Describe Phase 0
no therapeutic effects
Key words: FDA approval
- Done on large studies
Phase 3
Describe Phase 3
Key words: FDA approval
- Done on large studies
Key words: S-W-I-M (Safety-Work-Improvement- Market)
- Long term effects and safety concerns
Phase 4
Describe phase 4 trial
Key words: S-W-I-M (Safety-Work-Improvement- Market)
- Long term effects and safety concerns
Describe the features of permutated block randomization
2 groups & used for small studies; it’s good for maintaining balance
Describe the features of stratified block randomization
Involves 4 strata (ex. male 65 +/- & female 65 +/-)
Involves 4 strata (ex. male 65 +/- & female 65 +/-
Stratified block randomization
Describe open label blinding
no blinding in the study
no blinding in the study
Describe open label blinding
Describe triple blinding
The participants, researchers, and data analysts are all blinded
The participants, researchers, and data analysts are all blinded
Triple blinding
Describe double blind
Researchers and participants are both blind
Researchers and participants are both blind
Double blind
Describe what a metanalysis is?
Quantitatively combine and analyze the results from multiple studies on a specific topic, in order to draw more reliable and generalizable conclusions.
Describe the steps of performing a metanalysis
1) Define your research Q
2) Literature review
3) Select studies
4) Extract data
5) Analyze data
6) Report results
1) Define your research Q
2) Literature review
3) Select studies
4) Extract data
5) Analyze data
6) Report results
steps of performing a metanalysis
Quantitatively combine and analyze the results from multiple studies on a specific topic, in order to draw more reliable and generalizable conclusions.
Describe what a metanalysis is?
Describe inclusion factors
study design
population characteristics
treatment types
outcome measures
study design
population characteristics
treatment types
outcome measures
Are examples of what
Inclusion factors
Describe the steps of analyzing the data
1) Inverse variance weighing
2) unweighing inverse variance (via applying the random variance effects composition variable)
How do we unweigh inverse variance
random effects variance composition is determined by how much the effects of a study vary in terms of their size
random effects variance composition is determined by how much the effects of a study vary in terms of their size
REVC (Random effects variance composition)
Describe case control studies
Measure the ASSOCIATION between exposure to a factor & development of a disease (usually exposed group has more risk)
Measure the ASSOCIATION between exposure to a factor & development of a disease (usually exposed group has more risk)
Only use ODDS RATIO (can’t use relative risk)
Case-Control study
Describe a cohort study
observational study that follows a group of individuals with similar characteristics over a period of time to observe and analyze how certain factors or exposures influence the development of specific outcomes or diseases.
Use odds ratio OR relative risk
observational study that follows a group of individuals with similar characteristics over a period of time to observe and analyze how certain factors or exposures influence the development of specific outcomes or diseases.
Use odds ratio OR relative risk
Cohort study
Describe the features of Expressed attributable risk (EAR)
Key word: preventing disease
the additional risk or probability of developing a condition that can be directly attributed to a particular cause.
Key word: preventing disease
the additional risk or probability of developing a condition that can be directly attributed to a particular cause.
Exposed attributable risk (EAR)
Ratio of risks equation (incidence rates)
Disease risk in exposed / disease risk in unexposed
Disease risk in exposed / disease risk in unexposed
Ratio of risks
Difference in risk equation
(disease risk in exposed)-(disease risk in unexposed)
Relative risk (causation) equation
risk in exposed (incidence) / risk in non exposed (incidence)