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Dr. Kotb. Research Methodology Handout Full (Modified)
Dr. Kotb. Research Methodology Handout Full (Modified)
Notes
Definition
Research is the systematic collection, analysis
and interpretation of data to answer a certain
question or to solve a problem.
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Characteristics of Research
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Characteristics of Research..
3- Systematic: The research process
follows a certain logical sequence (steps
of scientific research).
4-Valid and verifiable: Research findings
are correct and can be verified by others
(reflect reality).
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Characteristics of research..
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Drivers for Health Research
1. Curiosity-driven research.
2. Needs-driven research.
3. Profit-driven research.
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Types of Research
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Types of Applied Research
1. Qualitative research : to gain familiarity with a new
phenomenon or experience of individuals.
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Characteristic of Health Services Research
5. It is short-term research.
1. Feasible
2. Interesting
3. Novel
4. Ethical
5. Relevant
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The Five Criteria of a Good Research question
(FINER Formula)
1. Feasible: can be done and completed.
2. Interesting: to the researcher and experts
3. Novel: contribute new information.
4. Ethical: in selecting & planning the research.
5. Relevant: has important implications.
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Good Research Question?
• Feasible • Ethical
– Experts – Social or scientific value
– participants – Safe of participants
– Resources • Relevant
– Management – Advance scientific knowledge?
– Data available – Influence clinical practice?
• Interesting – Impact health policy?
• Novel – Guide future research?
– Confirm or refute previous research?
– New idea
– New setting, new population
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Steps of conducting scientific Research
1.Formulating the Research Problem
2. Conduct Literature Review
3. Specify the Research Objectives
4. Define research questions and hypotheses
5. Specify Variables of the study
6. Select tools of data collection /questionnaire
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Steps of conducting scientific Research
7. Determine Population and sampling
8. Select the appropriate Research design
9. Train data collectors
10. Conduct Pretest / pilot study of the questionnaire
11. Collect Data
12. Analyze and Interpret Data
13. Prepare the Final Report
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RESEARCH PROBLEM
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Research problem
Definition (criteria)
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Research problem
Criteria for prioritizing research problems
1. Relevance: size, severity, who is affected
2. Avoidance of duplication
3. Feasibility: measures of feasibility (3 M)
4. Political acceptability
5. Applicability of research findings & recommendation
6. Urgency for data/ information for decision taking
7. Ethical acceptability of community & study participants
8. Community concern
9. Trend of health problem over years
10. Availability of data
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Criteria for prioritizing research problems
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3- Feasibility: Consider the availability of the required
resources and expertise who would help in
conduction of the proposed research.
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5. Avoidance of duplication: Before deciding your
research proposal, it is important to ensure that the
proposal has not been searched before, within the
proposed study population.
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7. Urgency for data: new health problems with
urgency of data are usually given higher priority for
funding.
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9. Political acceptability: It is advisable to select a research
topic that has the interest and support of the authorities. This
will facilitate approval and funding the proposed research .
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Analysis of the problem
1. Identify the opinion of : researchers, managers, decision-
makers and community members about the causes of the
problem, through brainstorming.
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Analysis of the problem
Classification of possible factors leading to the problem:
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LITERATURE REVIEW
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Literature review
Sources of literature review:
1- Searching Journal articles through internet
2- Books
3- National health reports and records
4- WHO health reports
5- Experts opinion
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Why is it important to conduct literature
review when preparing for a research?
1- It prevents duplicating research work that has
been done before.
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Research Questions Must Identify
1. The variables under study
2. The population being studied
3. The testability of the question
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Variables of the study
Variable definition:
A characteristic that differ from person to
person. Examples: age, sex, weight, height,
blood pressure, cholesterol level
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Variables in Research
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Types of variables
A- Qualitative variables : two types
1 - Qualitative nominal variables (categorical):
They are descriptive variables.
Examples: sex ( male, female) - anemia ( present,
absent) – blood groups (A, B, AB, O).
2- Qualitative ordinal variables:
They are descriptive variables that rank individuals.
Examples: grades of malnutrition (mild, moderate and
severe malnutrition) and grades of malignancy (
(grade0, grade1, grade 2, grade3 )
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Types of variables
B- Quantitative variables : two types
1 - Quantitative continuous variables:
These variables are measured and have fraction.
Examples: weight of a person 82.5 Kgm and height
110.6 cm.
2- Quantitative discrete variables:
These variables take only integer values. they are
counted. They do not have fraction. Examples:
heart beats , number of patients
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Dependent & Independent variables
1 - Dependent variable:
The variable that describe or measure the
problem of the study.
2- Independent variables:
The variables that are assumed to cause or
influence the problem.
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Dependent & Independent variables
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Confounding variable
Definition: a variable that can either strengthen
or weaken the association between the disease
and the possible cause.
Example: a cohort study on effect of smoking on
cancer lung. The study will involve 2 groups.
Smoking group and non smoking group. Age
could be a confounder, if the two groups were
not similar in age.
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Extraneous variables
Definition: background variables that might
influence exposure and disease relationship ,
some of the background variables are confounders
Example: a cohort study on effect of smoking on
cancer lung. The study will involve 2 groups.
Smoking group and non smoking group.
Occupation and environmental pollution could be
considered as background variables
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Hypothesis
• Statement about the relationship between
two or more variables.
• Why research hypothesis is important? it
enables the researcher to identify the
variables of the study and the data to be
collected.
• Rate of cancer prostate is higher in smokers
than non smokers among males aged ≥50
years in Jazan region.
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Characteristics of research hypotheses
1. Declarative statement that identifies the
predicted relationship between 2 or more
variables
2. Testability
3. It is Based on sound scientific theory/rationale
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Directional versus Non-Directional
Hypotheses
• Directional hypothesis
– Specifies the direction of the relationship between
independent and dependent variables
– Cure rate of drug A is higher than that of drug B
• Non-directional hypothesis
– Shows the existence of a relationship between
variables but no direction is specified
– Cure rates of drug A and drug B are different
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Research Hypothesis versus Statistical
Hypotheses
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State Statistical Hypotheses
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Hypotheses Testing : Purpose
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Hypotheses Testing : Steps
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P-value Definition
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Interpretation of p-value
Conventions
P > 0.05 non-significant
P 0.05 significant
P 0.01 highly significant
Examples
P =.27 non-significant
P =.01 highly significant
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Errors of statistical hypothesis testing
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Table of hypothesis testing :two
types of Error
a
a
False negative rate
b
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b
RESEARCH OBJECTIVES
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Lecture Outline
• Definition of research objective
• Importance of research objective
• Types of research objectives
• Examples of research objectives
• criteria of good research objectives
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Research Objectives
Definition of research objectives
• What is to be achieved by the end of the
study.
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TYPES OF OBJECTIVES
• General objective
• Specific objectives
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General Objective
• Characteristics of general objective
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Example:
Problem
increased number of diarrhea cases among children in village X
Specific objectives
-
-
-
-
-
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Example:
Problem
– Increased number of diarrhea cases among children in
village X.
Specific objectives
1.To find out relationship between breast feeding and
occurrence of diarrhea.
2.To find out relationship between education of mother and
occurrence of diarrhea.
3.To find out relationship between source of drinking water
and occurrence of diarrhea.
4.To determine the nutritional status of the children.
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Characteristics of Good Specific Objectives
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Characteristics of good specific objectives
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SMART
Specific
Measurable
Attainable
Realistic
Time bound
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Population and Sampling
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Population versus sample
Target Population
• Study Population
Sample
Sample frame
Sampling Unit:
Basic unit of sampling e.g. person, household, school
Sampling frame
List of all the sampling units from which sample is drawn
Sampling scheme
Method of selecting sampling units from sampling frame
Sample fraction
A ratio between sample size / population
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Populations and Sampling
Samples
Probability Samples
Non-Probability
Samples
Simple
Random Stratified
Multi-stage
quota snowball
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Sampling Methods
Non-probability samples
• Advantages:
- Save time
- lower cost
• Disadvantages:
– Does not involve random selection
– sampled are biased (Lack of accuracy)
– results can not be generalized to population
• Use
It is mainly used in qualitative research and social studies
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Sampling Methods
Non-probability samples (cont)
• Convenience sampling:
– We use available individuals or volunteers
– It is widely used in research done in health clinics
• Purposive sampling:
– We sample with purpose in mind
– We seek individuals with specified (predetermined)
criteria
– Main types are
1. Quota sampling
2. Snowball sampling
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Purposive Sampling
Quota sampling
– We seek individuals with specified (predetermined) criteria
– It is used in political & social studies
Snowball sampling
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Probability Samples
Subjects of the sample are chosen based on known probabilities.
Guarantees that every element in the population of interest has the same
probability of being chosen for the sample as all other elements in the
population; “random” selection.
Probability Samples
Simple
Random Systematic Stratified Cluster
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Advantage of Probability Samples
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Representative Sample
1) What is a representative sample?
2) When is it important to get a representative sample?
3) How to select representative sample?
A representative sample is a sample that resembles the
total population. It is important to get a representative
sample when want to understand the characteristics of
a population based on study of a sample (i.e., when you
want to directly generalize from your sample to your
population), through using random sampling
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1) Simple Random Sampling
Characteristics :
1. Every individual in population has an equal chance of
being selected
2. The simplest form of random samples
3. Use table of random numbers or computers
programs for obtaining the sample
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How to select a simple random sample?
1. Define the population
2. Determine the desired sample size
3. List all members of the population
4. Select the required sample
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2) Systematic Sampling
Steps of Selection
1) Population size: N
2) Sample size: n
3) Sample fraction ( F) = N/n
4) Select randomly one number within range of sample fraction
5) Select other individuals through consecutive adding of sample
fraction
12345678
First 1- 16
1) N = 200 individual
2) n = 25 in sample 17- 32
3) F = 8 33- 48
4) random number = 3
5) Individuals with serial No 11, 49 - 64
19, 27,35,…....
population
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Systematic Sampling (cont)
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Steps of Selecting a Systematic Sample
1. Define the study population
2. Prepare sample frame for the study population
3. Determine the desirable sample size
4. Calculate sample interval (k= N/n)
5. Select the 1st person randomly between 1 & K
6. Add sample interval to identify the consecutive
individuals
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3) Stratified Random Sampling
Characteristics
- It is the most accurate random sampling method
- It is used when the population is heterogeneous
- the population is divided into homogenous subgroups
(strata) according
to the stratifying variable
- The most important stratifying vaiables are : sex and age
.
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Stratified Random Sampling
Steps of selecting stratified sampling
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Stratified Random Sampling
Example:
We want to take a random sample (100 students) of
Fourth Year Medical students (1000 total students – 750
males and 250 females).
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4) Cluster Sampling
Definition:
It is a random sampling method in which the sampling unit (cluster / school) is
different from the study unit (school)
Main steps:
1) We divide the population into equal homogenous clusters
2) We select some clusters randomly
3) individuals in the selected are studied.
Examples:
Sample of primary school children in Jazan ( school)
Sample of women aged 15-49 in a village (household)
Sample of hospital Physicians working in Jazan ( hospitals)
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Types of Studies
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I- Observational Studies
Hypothesis generating
A. Descriptive studies:
Case report /Case series
Correlation studies
Cross-sectional studies
Hypothesis testing
B. Analytic studies:
Case-control
Cohort study
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II- Experimental Studies
Intervention studies (All are hypothesis testing)
Clinical trials
Community trials (quasi-experimental trial)
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Descriptive Studies
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1. Case reports (case study)
2. Case series
3. Correlation studies
4. cross sectional studies.
Descriptive studies provides information on various
characteristics of person-place-time.
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Cross-Sectional Studies (Prevalence studies)
• An “observational” design that measures existing disease
(D) and current exposure levels (E) at a single point in time
(a cross-section of the population)
• can not determine if really exposure preceded disease or
not. (Chicken egg dilemma)
time
Study only exists at this point in time
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Cross-sectional Design
factor present
Disease
factor absent
Study
population
factor present
No Disease
factor absent
time
Study only exists at this point in time
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Main steps of cross-sectional study:
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Main steps of cross-sectional study (cont.)
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Main steps of cross-sectional study (cont.)
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Characteristics of Cross-sectional Studies
• “Snapshot Studies”
• Describes what exist at a single point in time
• Each subject is assessed once at point in time.
• Point Prevalence Studies
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Uses of Cross Sectional Surveys
1. Estimate prevalence of disease in population
2. identify characteristics of the diseased person
3. Plan health care services
4. Generate hypotheses about risk factors of
disease.
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Advantages of Cross-sectional Studies
• Used to study conditions that are relatively frequent
with long duration (chronic conditions)
• Good for generating hypotheses about the cause of
disease
• Can estimate overall and specific disease prevalence
rates
• Can estimate exposure proportions in the population.
• Relatively easy, quick and inexpensive.
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Disadvantages of Cross-sectional Studies
• Impractical for rare diseases
• Not a useful type of study for establishing causal
relationships
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Advantages and Limitations of Cross
sectional Survey
Advantages
• Fairly quick and easy to perform
• Less expensive
Limitations
• Not useful to study disease etiology
• Not suitable for the study of rare disease
• Exposure and outcome examined at the
same time. e.g. Obesity and diabetes
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1. Assess the presence of diabetes mellitus in
relation to physical exercises.
2. Assess the presence of obesity in relation to
diabetes mellitus.
3. Assess the presence of varicose veins in relation to
the use of oral contraceptive pills.
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Summary of Descriptive Studies
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I- Observational Studies
A. Descriptive studies:
Case report
Case series
Hypothesis generating
Correlation studies
Cross-sectional studies
B. Analytic studies:
Cohort study Hypothesis testing
Case control
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(estimate and/calculate risks(
Basic Question in Analytic Epidemiology
Exposure Disease
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Cohort Studies
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What is a cohort?
• Cohort is a group having a common characteristic
smokers
Medical Students
Infants born in year 2008 (birth cohort)
Infants borne through C.S
Low birth weight infants
Women using contraceptive pills
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disease
Factor
Study present no disease
population
free of
disease Factor disease
absent
no disease
future
time
present Study begins here
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Types of Cohort Studies
Prospective cohort:
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Strengths of Cohort Studies
1. Can examine multiple effects of a single exposure
2. You are sure that exposure preceded outcome (temporal relation)
3. Can calculate relative risk and attributable risk.
4. Dose response relationship can be done.
5. Less liable for bias than case-control study.
6. Appropriate for studying rare exposure
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Limitations of Cohort Studies
1. Involve a large sample
2. Take a long time
3. Expensive.
4. They are not suitable for rare diseases
5. loss of persons during follow up (Attrition)
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Randomized Clinical Trial (RCT)
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Clinical trial
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Steps of conducting Randomized
Clinical trials (RCTs)
1. Identify target population: it is the population to which
results of the trial could be generalized
2. Identify study population: it is the population from which
participants will be recruited
3. List inclusion and exclusion criteria of the study
population
4. Get the "informed consent" from the study participants
5. Random allocation of participants to the experiment and
control groups.
6. Follow up of treatment response in experiment and
control groups
7. Compare treatment response in experiment and control
groups using statistical methods.
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Phases of Clinical Trial
of a New drug / Vaccine
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Phase I
– This phase aims to test effects of the drug on body
functions in volunteers
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Phase II
– It is also carried out on a small group of
volunteers.
– It lasts longer than phase I trials.
– The phase aims to:
1. To assess the effectiveness of the drug.
2. To determine the appropriate dosage, and
possible side effects.
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Phase III (randomized clinical trial)
– It is called randomized clinical trial
– It involves individuals, who should provide a
consent to participate in the trial..
– this phase aims to assess the efficacy and safety
of the drug.
– Results from phase III trials are used to decide
whether or not the new drug should be licensed
for use in the market.
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Phase IV (postmarking surveillance)
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Blinding
• Types
– Single – blinding (i.e., patient does not know whether he is
taking the new drug or the old drug )
– Double – blinding (both patient and investigator do not
know the new drug from the old drug )
– Triple – blinding (patient, investigator, analyst do not know
the new drug from the old drug )
• Can be impractical
– compare surgical vs. non-surgical treatment
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Advantages of Clinical Trials
• Permits manipulation and measurement of
treatment
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Disadvantages of Clinical Trials
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Human Research Ethics
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Fundamental Principles of
Human Research Ethics
• Human research ethics rest on 3 basic
principles that are considered the
foundation of all regulations and guideline
governing research ethics. These
principles are consider universal
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Respect for persons
• Respect for persons recognizes the capacity and right
of all individuals to make their own choices and
decisions. It refers to the respect of:
1- Autonomy, self-determination
2- Protection of vulnerable groups
—women, children, prisoners, mentally ill
—those with limited education
—the poor
—those with difficult access to health services
3- Informed consent
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Beneficence
- Beneficence refers to the principle of no harm.
- Beneficence makes researcher responsible for
the participant’s physical, mental and social
well-being through:
1- Reducing risks to a minimum
2- Protection of well-being of participant is
the primary responsibility of researchers.
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Justice
• The researcher’s obligation is to:
1) Recruitment and selection of participants
should be done in an equitable manner
2) Distribute equally the risks and benefits of
participation in the research
3) Special protection for vulnerable groups
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Informed consent
• Informed consent is a consent given by a
competent individual who:
1) Has received the necessary information
2) Has adequately understood the information
3) Has arrived at a decision without having
been subjected to coercion , undue
inducement
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Essential Elements of Informed
Consent
• Research description
– This is a research study?
– Purpose and objectives of study
– Expected participant’s responsibilities
– Procedures involved
– Study duration
– Explanation of randomization or placebo
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Essential Elements of Informed
Consent
⁻ Anticipated risks and benefits
⁻ Compensation for time and transport or injury
⁻ Confidentiality of participant data
⁻ Alternatives treatments and availability
⁻ Participants contacts for research related
questions
⁻ Voluntarism and right to discontinue without
penalty
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Elements of Ethical Treatment
• Full Information
• Voluntary participation
• Consent
• Privacy
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