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Experimental study design (5, RCT in clinical trials (Blinding (Single…
Experimental study design
1, overview of study desing for pharmacoepidemiology
Hypothesis testing ; interventional study (rct and quasi experiment)
2, principles of Study Design
Accuracy
Validity
Internal validity
External validity
Experimental Design
Experiment
Performed prosprective
Randomization
Interventional studies
Quasi-experimental designs
Randomization of dubjects
4, Randomization Controlled Trial (RCT)
Traditionally
Advantages
Disadvantages
Validity
Internal
Confounding bias
Selection bias
Jnformation bias
External validity
Systematic error / bias ;
Inappropriate study design
Improper su ject sampling
Inappropriate data analysis
Clinical trials
Therapeutic trials
Intervention trials
Prevention trials
5, RCT in clinical trials
Main objectives
Experimental study
Randomization
Blinding
Single-blind study
Double-blind study
Triple-blind study
Placebo
Control group
Experimental group
6, intention-to- traet and interim Analyses
7, Process (protocol) for designing a Clinical Trial
1, research question or hypothesis
2, rationale and background for study
Determine endpoints or outcomesnfor study
Study design
5, study population, inclusion and exclusion criteria
6, outline treatment procedures
7, define all clinical, laboratory and other tests
8, methods for ensuring integrity of the data
9, procedures for handling side effects and problem cases
10, procedures for obtaining informed consent
11, procedures for periodic review of trial data and termination of trial.
12, randomize patients to experimental and control groups.
13, compare treatment groips regarding baseline factors
14, perform follow up on monitor patients , including interim analyses.
15, Dstermine number of patients involved in final results and lost to follow up (intention -to-treat analysiz).
16, Calculate rates and confidence intervals for study data.
17, report nature and number of side effects and other problems.
18, Asses data and results in light of study questions or hypothesis.
Multisite clinical trial
Advantages and Disadvantages
9, Quasi-experiments
Absence of random assingment to treat groups
Nonequivalent control group design
Interrupted Time Series designs
Quasi-experimental design
Potential Issues in Nonrandom Group
Self selection
Performed groups
10, Reporting statements or Guidelines that can be Useful ahen Conducting Pharmacoepidemiologic Research