Statistics Flashcards
Aim of Phase 1 clinical trial
Evaluate toxicity
Study drug disposition, how its administered etc
Determine dose for phase 2
Aim of Phase 2 clinical trial
Estimate antitumor efficacy
Further define toxicity
Aim of Phase 3 clinical trial
Compare to standard of care
Aim of Phase 4 clinical trial
Post-marketing safety assessment
Formula for positive LR
PLR= Sensitivity/(1-specificity)
Remember use odds with LR, not probability
Formula for negative LR
NLR = (1 - Sensitivity)/Specificity
Remember use odds with LR, not probability
Formula for NNT
NNT=1/absolute risk reduction
Formula for odds ratio
OR = ad/bc
Formula for relative risk
RR = Probability in exposed/probability in non-exposed
What is selection bias?
Differences between baseline characteristics of the groups that are compared.
Problems with randomisation (allocation concealment and random sequence generation)
What is performance bias?
Differences between groups in the care that is provided, or in exposure to factors other than the interventions of interest.
Problems with blinding or patient or personnel
What is detection/observer bias?
Differences between groups in how outcomes are determined.
Problems with blinding of outcome assessment
What is attrition bias?
Differences between groups in withdrawals from a study.
Problems with incomplete outcome data
What is reporting bias?
Differences between reported and unreported findings.
Not all study findings reported
What is publication bias?
Tendency not to publish negative studies, only positive results published
