General methodological study Flashcards
What are the two types of study design category?
Observational: naturally observing lives of people. Are not researcher-forced group allocations
Interventional: experimentally driven, with a researcher-forced group allocation
List the Observational categories.
- cohort
- case-control
- cross-sectional
What are the experimental.
- randomized and non-randomized allocations
Equipoise
Genuine confidence may be risk vs benefit in human trials
4 principles of Bioethics
- Autonomy: self-rule and determination
- beneficence: idea to benefit Pt regardless of their assigned group
- Justice: equal and fair treatment regardless of characteristics
- Non-maleficence: do no harm. Can’t withold info, or present incompetence.
Assent
Consent
A: agree to participate with full understanding and mental capability. Not of legal age.
C: agree to participate with full understanding and mental capability, and of legal age or by parent/guardian.
IRB has what influence?
IRB: will protect the 4 bioethics of of people in the study BEFORE the study begins. and is broken into 3 different levels.
What are the 3 different levels of IRB?
- Full board: used for interventional trials with more than no-risk.
- Expedited: Minimal risk and no patient identifiers.
- Exempt: Lowest and easiest to get approval from.
After the IRB, who monitors the Pt safety during a study?
The data safety and monitoring board. that assess for safety during the study.
What is problematic withing certain studies that can occur?
Possible to have generalization which will not extend to the overall population of the community.
Belmont Report contained what?
- Respect for persons: autonomous subjects
- Beneficence: risk justified by benefits
- Justice: equal distribution of risk/benefits
What is the key difference of an interventional study compared to an observational study?
- investigator selects interventions and forced-group interventions
- readily shows causation
Phases of Interventional Study Design…
- Pre-clinical
2. Phase 1-4
Pre-clinical stage of study
This phase is before human trials and demonstrates some type of need for the intervention that is going to be made
phase 1
Start human trial tests. Small groups, Sometimes have the infected population.
Focused on safety.
Analyzing pharmacokinetics.
Short time frame
Phase 2
Focused on effectiveness and efficacy.
Medium time frame, 100-400 population.
Restricted selection to reduce chance of change by factor other than the drug, or intervention.
If too narrow of restriction; results are not generalized to large populations
Phase 3
Longer time frame. More focus on efficacy for the intended target in the intended target group. Analyze the safety in diseased individuals.
Phase 4
Safety is large concern.
Views long term effects after FDA approval. Must be named drug at this point.
hundreds of thousands of people involved.
Describe advantages of Interventional Study Design
- The cause precedes the effect and is used for FDA approval process.
Why would you not want to perform Interventional study design?
High cost.
Time consuming
Risk vs Benefits (Equipoise) Ethics
Possibility of a too specific study group. Problem?
Name the 4 types of interventional study designs
- simple
- factorial
- parallel
- cross-over (self-control) group
Simple interverntional study design
Analyze one hypothesis with 2 or more groups
Factorial Interventional study design
A set of groups is further divided into sub-groups. Benefit to analyze a multi-leveled hypothesis. (like a flow-sheet)
Parallel Interventional study design
groups are simultaneously and exclusively managed.
no switching of intervention groups after initial randomization
Cross-Over
Group serves by controlling intervention compared to another study.
Hawthorne Effect
Show compliance before the study begins.
Run-in/Lead-in phase.
study population given 1 or more placebos for therapy to determine “new” baseline of disease
