1. Introduction to Research Methods in Psychology
L.A. Siegel, MA, CSE, AASECT

2. Three Types of Research
Causal Research
determines if one variable causes another variable to occur or change.
2. Descriptive Research
seeks to depict what already exists in a group or population (eg, opinion poll, market survey)
3. Relational Research
investigates the connection between two or more variables generally already present in the group or population (eg, gender and music preference)

3. Some important distinctions between theory and hypothesis
A theory is has been extensively tested and is based on generally accepted facts. A theory is a well-established principle that has been developed to explain some aspect of the natural world. A theory arises from repeated observation and testing and incorporates facts, laws, predictions, and tested hypotheses that are widely accepted.
A hypothesis is a speculative guess that has yet to be tested

4. Effect of Time in Psychology Research
Cross-sectional research (single point in time)
Seeks to gather data on present conditions instead of looking at the effects of a variable over a period of time.
2. Longitudinal research (over a period of time)
Data is first collected at the outset of the study, and may then be gathered repeatedly throughout the length of the study.
Some longitudinal studies may occur over a short period of time, such as a few days, while others may take place over a period of decades.

5. Causal Relationships Between Variables
A causal relationship is when one variable causes a change in another variable. These types of relationships are investigated by experimental research in order to determine if changes in one variable truly causes changes in another variable

6. Correlational Relationships Between Variables
A correlation is the measurement of the relationship between two variables that already occur in the group or population; not controlled by the experimenter.
positive correlation
negative correlation

9. What is a Simple Experiment?
is used to establish cause and effect; often used to determine the effect of a treatment.
study participants are randomly assigned to one of two groups.
control group: receives no treatment
experimental group: receives treatment.

10. Parts of a Simple Experiment
The experimental hypothesis: a statement that predicts that the treatment will cause an effect.
The null hypothesis: a hypothesis that the experimental treatment will have no effect on the participants or dependent variables.

11. Parts of a Simple Experiment
The independent variable: the treatment variable manipulated by the experimenter.
The dependent variable: the response that the experimenter is measuring.

12. Determining the Results of a Simple Experiment
The key to determining if a treatment had an effect is to measure the statistical significance.
Statistical significance shows that the relationship between the variables is probably not due to mere chance and that a real relationship most likely exists between the two variables. Statistical significance is often represented as:
p < .05 or .01

13. What is Validity?
Validity is the extent to which a test measures what it claims to measure. It is vital for a test to be valid in order for the results to be accurately applied and interpreted.

14. What Is Reliability?
Reliability refers to the consistency of a measure.
A test is considered reliable if we get the same result repeatedly. .

15. Types of Research Design
Case Series and Case Reports:
Collections of reports on the treatment of individual patients with the same condition, or of several reports on a single patient
Case Control Studies:
Patients who already have a certain condition are compared with people who do not.

16. Randomized Controlled Studies:
Cohort Studies:
longitudinal studies involve a case-defined population who presently have a certain exposure and/or receive a particular treatment that are followed over time.
Randomized Controlled Studies:
treatment group and control group are randomly assigned. The treatment group receives the treatment under investigation, and the control group receives either no treatment (placebo) or standard treatment.
Considered the “Gold” Standard in Medical Research

17. Double Blind Method: Single-Blind Method:
randomized controlled clinical study in which neither the research staff nor the subject knows which of several possible treatments/therapies the patient is receiving.
Single-Blind Method: 
researchers know which group is receiving which treatment. Allows for bias on the part of the researchers conducting the study.

18. Clinical Development: The Fundamentals
Phase of study
Aim
Subject population
Number of subjects
Approximate duration (years)
Phase I
Pharmacokinetics
& Safety
Healthy volunteers
50–100 1
Phase II
Proof of concept
Dose–response
Patients
100–300 2
Phase III
Efficacy
Target patient population
1,000–5,000 3
Phase IV
Post approval
Variable

19. Phase I – Data Collected
Bioavailability
Peak serum concentration (Cmax)
Time to maximum concentration (Tmax)
Area under the curve
Tolerability and safety
Effects on vital signs
Half-life (T½)
Pharmacokinetics
Pharmacodynamics
Protein binding
Dosage form
Food effect
Drug–drug interactions

20. Phase II – Data Required
Safety profile in patients
Proof of concept
Dose range
Frequency of dosing
Safety/tolerability

21. Phase III – Formal Trials
Two identical trials to demonstrate:
Multi-center, multi-national trials
Long-term safety
Controlled, blinded, and randomized

22. Phase IV – Commitments Post approval, therapeutic use
Additional safety data
Long-term/chronic use
Differentiate from other drugs in class
Cost-effectiveness

23. FDA Review Process
Takes approximately one year for the FDA to review a New Drug Application (NDA). Review is done by the Division of Reproductive and Urological Products
Often hold an Advisory Board Meeting to review data from clinical trials and to offer recommendations regarding approval
In general, FDA follows the recommendations of the Advisory Board
Three possibilities
Approval
Letter of Approvability
Letter of Non-approval

24. Contributions to the Approval Process
Regulatory Environment &
Societal Influences
Efficacy
Safety

25. In What Ways Do We Live Our Lives According to the Scientific Method?