RANDOMIZED CONTROLLED

TRIAL (RCT)
DR.D.SARAVANAN.,MD.,DPH.,
GDMCH

1
 METHOD OF KNOWLEDGE IS
EXPERIMENT

-- WILLIAM BLAKE
 CONTENTS

 INTRODUCTION

 STEPS IN CONDUCTING RCT

 TYPES OF RCT
 ETHICAL CONSIDERATIONS
 CONCLUSIONS
 REFERENCES
 QUESTIONS
 INTRODUCTION

• EPIDEMIOLOGY IS DERIVED FROM THE WORD “EPIDEMIC”

• EPIDEMIOLOGY IS THE STUDY OF THE DISTRIBUTION AND

DETERMINANTS OF HEALTH-RELATED STATES OR EVENTS IN

SPECIFIED POPULATIONS AND APPLICATION OF THIS STUDY TO
THE CONTROL OF HEALTH PROBLEMS.

( JOHN M. LAST IN 1988 )

4
 CLASSIFICATION
• 1. OBSERVATIONAL STUDIES
A. DESCRIPTIVE STUDIES
B. ANALYTICAL STUDIES
(I) ECOLOGICAL
(II) CROSS-SECTIONAL
(III) CASE-CONTROL
(IV) COHORT

• 2. EXPERIMENTAL/INTERVENTION STUDIES

A. RANDOMIZED CONTROLLED TRIALS

B. FIELD TRIALS
C. COMMUNITY TRIALS
 HUMAN EXPERIMENT

1747 -- JAMES LIND -- TOOK 12 PATIENTS IN SCURVY ON BOARD THE

SALISBURY AT SEA
 EXPERIMENTAL STUDIES

• IN THE 1920S, “EXPERIMENTAL EPIDEMIOLOGY” MEANT THE STUDY

OF EPIDEMICS AMONG COLONIES OF EXPERIMENTAL ANIMALS SUCH

AS RATS AND MICE.

• EXPERIMENTAL OR INTERVENTION STUDIES ARE SIMILAR IN

APPROACH TO COHORT STUDIES EXPECTING THAT THE CONDITIONS IN
WHICH STUDY IS CARRIED OUT ARE UNDER THE DIRECT CONTROL OF
THE INVESTIGATOR.
• Experimental studies involve some action, intervention or

manipulation such as deliberate application or withdrawal of the

suspected cause or changing one variable in the causative chain in
the experimental group while making no change in the control group.

..Observing and comparing the outcome of the experiment in both the groups.

• This contrasts sharply with observational studies (descriptive, case control, cohort
studies), where the epidemiologist takes no action but only observes the natural
course of events or outcome.
 AIMS
• TO PROVIDE “SCIENTIFIC PROOF” OF ETIOLOGICAL OR RISK FACTORS WHICH
MAY PERMIT THE MODIFICATION OR CONTROL OF THOSE DISEASES.

• TO PROVIDE A METHOD OF MEASURING THE EFFECTIVENESS AND

EFFICIENCY OF HEALTH SERVICES FOR THE PREVENTION, CONTROL AND

TREATMENT OF DISEASES AND IMPROVE THE HEALTH OF THE COMMUNITY.

 ADVANTAGES OF EXPERIMENTAL
RESEARCH DESIGNS

• RESEARCHER ‘CONTROL’ OVER THE INTERVENTION AND OVER

WHICH

SUBJECTS RECEIVE ANY INTERVENTION.

• RESULTS ARE ENSURED.

• RELIABLE AND WELL-RESPECTED RESEARCH DESIGN

• INDIVIDUAL FACTORS CAN BE IDENTIFIED.

 DISADVANTAGES OF EXPERIMENTAL
RESEARCH DESIGNS

• PROBLEMS IN DEALING WITH MULTIPLE CAUSATION; ISOLATING INDIVIDUAL

FACTORS MAY OVER-SIMPLIFY COMPLEX ISSUES.

• ETHICAL ISSUES.
• RESEARCHER BIAS AND SUBJECTIVITY IN RESEARCH DESIGN,
METHODS AND ANALYSIS.
• HAWTHORNE EFFECT UPON GROUPS BEING RESEARCHED.

(HAWTHORNE EFFECT– ITS ATTENTION BIAS TYPE OF SELECTION BIAS –

STUDY SUBJECTS SYSTEMATICALLY ALTER THEIR BEHAVIOR)

 WHAT IS A RANDOMIZED CONTROLLED
TRIAL?
• RCT IS WIDELY REGARDED AS GOLD STANDARD FOR EVALUATING
HEALTH
CARE TECHNOLOGIES AS IT ALLOWS US TO BE CONFIDENT THAT A
DIFFERENCE
IN OUTCOME CAN BE DIRECTLY ATTRIBUTED TO A DIFFERENCE IN THE
TREATMENTS & NOT DUE TO SOME OTHER FACTOR.
 DEFINITION

• RCTS ARE QUANTITATIVE, COMPARATIVE, CONTROLLED

EXPERIMENTS IN WHICH INVESTIGATORS STUDY TWO OR
MORE INTERVENTIONS IN A SERIES OF INDIVIDUALS WHO
RECEIVE THEM IN RANDOM ORDER.

THE RCT IS ONE OF THE SIMPLEST AND MOST POWERFUL TOOLS IN

CLINICAL RESEARCH.
 WHAT IS THIS METHOD OF CARRYING OUT SCIENTIFIC RESEARCH,
AND WHY IS IT SO HIGHLY VALUED?

• A RCT IS AN EXPERIMENT OR STUDY CONDUCTED IN SUCH A WAY THAT AS MANY

SOURCES OF BIAS AS POSSIBLE ARE REMOVED FROM THE PROCESS.

• BASICALLY, SCIENTIFIC ERRORS OF THE PAST HAVE TAUGHT US WHERE WE CAN GO

WRONG,
DRAWING FALSE CONCLUSIONS FROM OUR RESEARCH.
RCTS ARE DESIGNED TO ELIMINATE THESE MAJOR ERRORS.

• FOR NEW PROGRAMMES OR NEW THERAPIES, THE RCT IS THE NO.1 METHOD FOR
EVALUATION.
DESIGN OF RANDOMIZED CONTROLLED TRIAL
Select suitable population (reference or target)

Select suitable sample (experimental or study)

Those not eligible

Make necessary exclusions Those who do not

wish to give consent
Randomize

Experimental
Control

Manipulation & Follow-up

Assessment
 1. DRAWING UP A PROTOCOL
• STRICT PROTOCOL
• AIMS , OBJECTIVES & SAMPLE SIZE
• QUESTIONS TO BE ANSWERED
• CRITERIA OF SELECTION: STUDY & CONTROL GROUPS
• INTERVENTION TO BE APPLIED
• STANDARDIZATION OF WORKING PROCEDURES
• SCHEDULES
STRICTLY FOLLOWED THROUGH OUT THE STUDY
 PRELIMINARY TEST RUNS

• SOMETIMES, BEFORE A PROTOCOL IS COMPLETED, PRELIMINARY(PILOT) STUDIES HAVE TO

BE MADE TO FIND OUT THE FEASIBILITY OR OPERATIONAL EFFICIENCY OF CERTAIN
PROCEDURES OR UNKNOWN EFFECTS OR THE ACCEPTABILITY OF CERTAIN POLICIES.

• SOMETIMES IT IS USEFUL TO HAVE A SHORT TEST RUN OF THE PROTOCOL TO SEE WHETHER IT

CONTAINS FLAWS.

• IT IS IMPORTANT THAT THE FINAL VERSION OF THE PROTOCOL SHOULD BE AGREED UPON

BY ALL CONCERNED BEFORE THE TRIAL BEGINS.

 2. SELECTING REFERENCE AND EXPERIMENTAL
POPULATION
A) REFERENCE OR TARGET POPULATION:
 IT IS THE POPULATION TO WHICH THE FINDINGS OF THE TRIAL IF FOUND SUCCESSFUL,

ARE EXPECTED TO BE APPLICABLE.

 IT MAY BE AS BROAD AS MANKIND OR IT MAY BE GEOGRAPHICALLY LIMITED OR LIMITED TO

PERSONS IN SPECIFIC AGE, GENDER , OCCUPATIONAL OR SOCIAL GROUPS.

 E.G.: POPULATION OF THE WHOLE CITY, SCHOOL CHILDREN, INDUSTRIAL WORKERS,

ETC…,
b) Experimental /Study Population:

• It is derived from the reference population.

• Ideally should be randomly chosen from the reference population.

• It should have the same characteristics as target population.

• It is also important to choose a stable population whose cooperation is

assured
to avoid loses to follow-up.
 3. RANDOMIZATION

• “HEART" OF A CONTROL TRIAL.

• IT IS THE STATISTICAL PROCEDURE BY WHICH THE PARTICIPANTS ARE

RANDOMLY ALLOCATED INTO GROUPS USUALLY CALLED THE "STUDY" AND
"CONTROL" GROUPS.

• IT IS AN ATTEMPT TO ELIMINATE "BIAS" AND ALLOW FOR COMPARABILITY.

• STUDY GROUP SHOULD FULFILL THREE CRITERIA:

1. SHOULD BE “REPRESENTATIVE” OF THE REFERENCE POPULATION

2. “INFORMED CONSENT” IS MUST (INFORM ABOUT PROCEDURE
AND POSSIBLE DANGERS)
3. THEY MUST BE “SUSCEPTIBLE” TO THE DISEASE UNDER STUDY
Randomization eliminates “selection bias”

• Randomization is done only after the participant has entered the study and it can
be done by using table of random numbers.

• In other words, by random allocation, every individual gets an equal chance of

being allocated into either group.

• Finally, randomization guarantees that statistical tests of significance will be

valid.
 TYPES OF RANDOMIZATION

1. RANDOM ASSIGNMENT:
 FLIP A COIN
• “HEADS”—T X A
• “TAILS”—T X B

 ROLL A SIX-SIDED DICE

• EVEN NUMBER—T X A
• ODD NUMBER—T X B
2. BLOCK RANDOMIZATION:

• Subjects are divided into ‘blocks’ and randomization is carried out in each
blocks.

• Ex; for two treatments and a block size of four, two of every four consecutive
patients would receive the experimental therapy and the other two would
receive control therapy.

EECC,ECEC, ECCE, CCEE, CECE,……..

3. STRATIFIED RANDOMIZATION:

• It may be important to ensure that the treatment and control groups are balanced
on important prognostic factors that can influence the study outcome
(e.g., gender, ethnicity, age, socioeconomic status).

• Before doing the trial, the investigator decides which strata are important and
how many stratification variables can be considered given the proposed sample
size.

A separate simple or blocked randomization schedule is developed for

each stratum.
 4. MANIPULATION
• DELIBERATE APPLICATION OR WITHDRAWAL OF THE SUSPECTED CAUSAL FACTOR AS
LAID DOWN IN THE PROTOCOL.

EG : DRUG, VACCINE, DIETARY COMPONENT, HABIT

• MANIPULATION CREATES AN INDEPENDENT VARIABLE (DRUG, VACCINE, NEW

PROCEDURE) WHOSE EFFECT IS THEN DETERMINED BY THE MEASUREMENT OF THE FINAL
OUTCOME,

WHICH CONSTITUTES THE DEPENDENT VARIABLE (INCIDENCE OF DISEASE, SURVIVAL TIME,

RECOVERY PERIOD).
 5. FOLLOW-UP
• EXAMINATION OF GROUPS AT DEFINED INTERVALS OF TIME
UNDER THE SAME CONDITIONS, IN A STANDARD
MANNER, WITH EQUAL INTENSITY, SAME CIRCUMSTANCES,
SAME TIME FRAME.
• FOLLOW-UP CAN VARY FROM A SHORT PERIOD TO MANY YEARS.
• OVER THE YEARS, THERE MAY BE LOSS OF SUBJECTS FROM EITHER
GROUP DUE TO A NUMBER OF REASONS. THIS IS CALLED AS
“ATTRITION”.
 DEATH
 MIGRATION
 LOSS OF INTEREST
 6. ASSESSMENT
THE FINAL STEP IN THE OUTCOME OF THE TRIAL IS IN TERMS OF:

a) POSITIVE RESULTS:

THAT IS, BENEFITS OF THE EXPERIMENTAL MEASURE SUCH AS REDUCED

INCIDENCE OR SEVERITY OF THE DISEASE, COST TO THE HEALTH SERVICE
OR OTHER APPROPRIATE OUTCOME IN THE STUDY AND CONTROL GROUPS.

B) NEGATIVE RESULTS:

THAT IS, ADVERSE EFFECTS, SEVERITY AND FREQUENCY OF SIDE EFFECTS

AND COMPLICATIONS, IF ANY INCLUDING DEATH.
Errors in assessment can lead to “Bias”
(systematic error in epidemiological study).

• Bias can arise from three sources:

Subject variation
Observer bias
Evaluation Bias

• Randomization cannot guard against these sort of bias.

• To avoid the above situations, “Blinding” is done.

 BLINDING :
BLINDING CAN BE DONE IN THREE WAYS –
(a) SINGLE BLIND TRIAL :
THE TRIAL IS SO PLANNED THAT THE PARTICIPANT IS NOT AWARE WHETHER HE BELONGS
TO THE STUDY GROUP OR CONTROL GROUP
(B) DOUBLE BLIND TRIAL :
THE TRIAL IS SO PLANNED THAT NEITHER THE DOCTOR NOR THE PARTICIPANT IS AWARE
OF THE GROUP ALLOCATION AND THE TREATMENT RECEIVED
(C) TRIPLE BLIND TRIAL :
PARTICIPANT, INVESTIGATOR AND PERSON ANALYZING THE DATA ALL ARE "BLIND".
IDEALLY, OF COURSE, TRIPLE BLINDING SHOULD BE USED;
BUT DOUBLE BLINDING -- MOST FREQUENTLY USED METHOD.
 TYPES OF RANDOMIZED CONTROLLED TRIALS

BASED ON RANDOMIZATION:
1. RANDOMIZED CONTROLLED TRIALS:
WHERE RANDOMIZATION IS USED FOR ALLOCATION OF PRODUCTS AND / OR SUBJECTS.

2. NON-RANDOMIZED OR “NON-EXPERIMENT” OR QUASI-EXPERIMENT:

DEPARTING FROM STRICT RANDOMIZATION FOR PRACTICAL PURPOSES IN SUCH A MANNER
THAT NON-RANDOMIZATION DOES NOT SERIOUSLY AFFECT THE THEORETICAL BASIS OF
CONCLUSIONS.
E.G. NATURAL EXPERIMENTS, WATER FLUORIDATION STUDIES,
UNCONTROLLED TRIALS(NO CONTROLS), BEFORE & AFTER COMPARISON TRIALS
BASED ON STUDY DESIGNS:
1. Concurrent parallel study design:
• In this design, comparisons are made between two randomly assigned groups,

one group exposed to specific treatment and the other group not exposed.

• Patients remain in the study group or the control group –during the investigation.

2. Factorial Design:
• More efficient than a parallel design if there is an interest in studying more
than one intervention at a time.

• In addition to efficiency, an advantage is that one might derive suggestions of

differential effect of treatment in the presence or absence of the other treatment.
3. Cross-over type of study designs:

• With this type of study design, each patient serves as his own control.

• As before, the patients are randomly assigned to a study group and control
group. The study group receives –treatment, control group receives some
alternate form of active treatment or placebo.

. The two groups are observed over time. Then the patients in each group are
taken off their medication or placebo to allow for the elimination of the
medication from the body and for the possibility of any "carry over" effect.

• After this period of medication the two groups are switched.

BASED ON USES:

1. CLINICAL TRIALS
2. PREVENTIVE TRIALS
3. RISK FACTOR TRIALS
4. CESSATION EXPERIMENT
5. TRIAL OF ETIOLOGICAL AGENTS
6. EVALUATION OF HEALTH SERVICES
7. COMMUNITY INTERVENTION TRIALS
 1. CLINICAL TRIALS

WHO DEFINITION OF A CLINICAL TRIAL:

ANY RESEARCH STUDY THAT PROSPECTIVELY ASSIGNS HUMAN

PARTICIPANTS OR GROUPS OF HUMANS TO ONE OR MORE HEALTH-
RELATED INTERVENTIONS TO EVALUATE THE EFFECTS ON OUTCOMES.

HEALTH OUTCOMES INCLUDE ANY BIOMEDICAL OR HEALTH-RELATED

MEASURES OBTAINED IN PATIENTS OR PARTICIPANTS, INCLUDING
PHARMACOKINETIC MEASURES AND ADVERSE EVENTS.
 EARLY TRIALS…
• 1747 - JAMES LIND STUDY ON SCURVY PATIENTS
• 1796 – EDWARD JENNER EXPERIMENT WITH COW POX
• 1881-1900 – FINLAY AND REEDS -- TO ELUCIDATE MOSQUITO-BORNE
NATURE
OF YELLOW FEVER
• 1915– GOLDBERGER’S STUDY INDUCING PELLAGRA BY DIET DEFICIENT
IN
NICOTINIC ACID
.. 1945 – WATER FLUORIDATION STUDY
• 1953 – FIRST RANDOMIZED CONTROLLED TRIAL ON TUBERCULOSIS
 PHASES OF CLINICAL TRIAL

Traditionally, clinical trials of new therapies or devices pass through the following phases:

1.Phase I clinical trial – trial on a small group(10-30) of health individuals to know the
safety, efficacy and side effects of vaccine. (8-12 months)

2. Phase II clinical trial– trial on large group (50 -500) to know not only safety but also
refining the dose schedule, in multiple centers.(18-24 months)
phase II b (step study or test of concept trial) – enables the researcher to decide whether
is it worth testing in large.

3. Phase III clinical trial – trial in thousands of volunteers not only safety and dose ,

whether vaccine is fit for manufacturing.

4. Phase IV clinical trial – continuous ongoing process to know long term effects.
 2. PREVENTIVE TRIALS

-- TO PREVENT OR ELIMINATE DISEASE ON AN EXPERIMENTAL

BASIS.
• THE MOST COMMONLY OCCURRING TRIALS ARE THAT OF VACCINES
AND CHEMO PROPHYLACTIC DRUGS.
EG: TRIAL OF WHOOPING COUGH VACCINES, CARIES VACCINE.

• PREVENTIVE TRIALS INVOLVE LARGER NUMBER OF SUBJECTS AND

LONG SPAN OF TIME TO OBTAIN RESULTS, HENCE ARE ASSOCIATED
WITH GREATER NUMBER OF PRACTICAL PROBLEMS IN THEIR
ORGANIZATION AND EXECUTION.
 3. RISK FACTOR TRIALS
• PREVENTIVE TRIAL OF RISK FACTORS IN WHICH THE INVESTIGATOR INTERVENES
TO INTERRUPT THE USUAL SEQUENCE IN THE DEVELOPMENT OF DISEASE FOR
THOSE INDIVIDUALS WHO HAVE “RISK FACTOR” FOR DEVELOPING THE DISEASE;

OFTEN THIS INVOLVES RISK FACTOR MODIFICATION.

• CAN BE EITHER “SINGLE FACTOR” OR “MULTI FACTOR”.

• E.G.:

WHO PROMOTED TRIAL ON PRIMARY PREVENTION OF CHD WAS LARGEST

PREVENTIVE TRIAL.
 4. CESSATION EXPERIMENTS

• ATTEMPT IS MADE TO EVALUATE THE TERMINATION OF A HABIT,

WHICH IS CONSIDERED TO BE CAUSALLY RELATED TO A DISEASE.
• IF IT RESULTS IN SIGNIFICANT REDUCTION OF THE DISEASE,

THE HYPOTHESIS OF CAUSE IS STRENGTHENED. E.G. SMOKING & LUNG CANCER

5. TRIAL OF ETIOLOGICAL AGENTS

.. TO CONFIRM OR REFUTE AN ETIOLOGICAL HYPOTHESIS.
• SINCE MOST DISEASES ARE FATAL, DISABLING OR UNPLEASANT HUMAN EXPERIMENTS TO CONFIRM
ETIOLOGICAL HYPOTHESIS ARE RARELY POSSIBLE.
EX: DEVELOPMENT OF RETROLENTAL FIBROPLASIA (RLF) IN PREMATURE BABIES EXPOSED TO
OXYGEN
6. EVALUATION OF HEALTH SERVICES

To assess the effectiveness and efficiency.

• Since resources are limited & priorities must be set for the implementation - large
number of activities.
• Eg: TB regimen in India – Demonstrated that “domiciliary treatment” of pul. TB was as
effective as the more costlier “hospital treatment”.

7. COMMUNITY INTERVENTION TRIALS (CITs)

CITs are carried out in hospitals or clinics and are usually directed at
a patient group with specific health conditions.

• However, randomized experiments are also sometimes done in the community.

• In these types of studies, the major difference from the RCT is that the
randomization is done on communities rather than individuals.
 ETHICAL ISSUES IN CLINICAL TRIALS
CLINICAL TRIALS SHOULD FOLLOW 3 PRINCIPLES:

• BENEFICENCE: WHICH REQUIRE THAT GOOD SHOULD RESULT, HARM SHOULD BE

AVOIDED,
OR THAT BENEFITS SHOULD JUSTIFY THE EXPECTED RISK OR HARM.

• RESPECT FOR RIGHTS: INCLUDING THE FREE CHOICE OF THE SUBJECT AND
PROTECTION FOR THOSE DIMINISHED AUTONOMY.

• JUSTICE: WHICH REQUIRE AN EQUAL DISTRIBUTION OF BURDEN AND BENEFITS

 QUALITY ASSESSMENT OF RCTS

VARIOUS APPROACHES USED:

CHECKLIST APPROACH
QUALITY SCORING SYSTEM APPROACH

QUALITY SCORES ARE COMPLICATED AND TEND TO VARY

DEPENDING ON THE INSTRUMENT USED –SO, NOT ENCOURAGED
CHECKLIST APPROACH
 QUALITY SCORE APPROACH

Jadad AR, et al. Assessing the quality of reports on randomized clinical trials: Is blinding necessary?
Controlled Clin Trials1996;17:1-12. URL: http://www.bmjpg.com/rct/chapter4.html
 CONCLUSIONS

“GOLD STANDARD” OF RESEARCH DESIGNS

• INDIVIDUAL PATIENTS ARE RANDOMLY ALLOCATED TO RECEIVE THE EXPERIMENTAL
TREATMENT (INTERVENTION GROUP) OR THE STANDARD TREATMENT (CONTROL
GROUP)
• MAXIMIZES THE POTENTIAL FOR ATTRIBUTION
• GOOD INTERNAL VALIDITY
• MAY LACK GENERALIZABILITY DUE TO HIGHLY SELECTED PARTICIPANTS.
• CAN BE COSTLY TO SET UP AND CONDUCT, ETHICAL ISSUES.
• DETAIL REPORT OF THE TRIAL IS WRITTEN AND SENT TO MEDICAL PUBLICATION.
(MUST)
 REFERENCES

• PARK’S TEXTBOOK OF PREVENTIVE AND SOCIAL

MEDICINE , K.PARK . 25TH EDN.,
• JADAD AR, ET AL.
ASSESSING THE QUALITY OF REPORTS ON RANDOMIZED CLINICAL TRIALS: IS BLINDING
NECESSARY? CONTROLLED CLIN TRIALS1996;17:1-12. URL:
HTTP://WWW.BMJPG.COM/RCT/CHAPTER4.HTML
 MCQ’S

1. THE HEART OF RANDOMIZED CONTROL TRAIL IS?

a) PROTOCOL
b) INTERVENTION
c) RANDOMIZATION
d) NONE OF THE ABOVE
2. IN A DOUBLE BLIND CLINICAL DRUG TRIAL?

a) EACH PATIENT RECEIVES A PLACEBO

b) EACH PATIENTS RECEIVES BOTH TREATMENT
c) NEITHER THE PATIENT NOR THE DOCTOR DO NOT KNOW WHICH
TREATMENT WHO ARE RECEIVING
d) THE PATIENTS DO NOT KNOW THAT THEY ARE IN A DRUG TRIAL
3.GOLD STANDARD STUDY FOR CLINICAL RESEARCH IS ?

a) RANDOMIZED CONTROL TRIAL

b) SYSTEMATIC META-ANALYSIS
c) ECOLOGICAL STUDY
d) RETROSPECTIVE COHORT STUDY
4. IN WHICH PHASE OF CLINICAL TRIAL “SAFETY AND DOSE
REFINING”
IS EVALUATED?

a) PHASE 1
b) PHASE 2
c) PHASE 3
d) PHASE 4
5.TYPE OF RCT, IN WHICH BOTH GROUPS (EXPERIMENT &
REFERENCE ) ACT AS EXPOSED GROUP AS WELL AS NON EXPOSED
GROUP?

a) UNCONTROLLED TRIAL
b) CONCURRENT PARALLEL TRIAL
c) CROSS OVER TRIAL
d) NATURAL EXPERIMENT
 PREVIOUS YEAR UNIVERSITY EXAM QUESTIONS

1. DEFINE EPIDEMIOLOGY ?

2. WHAT IS STRATIFIED RANDOM SAMPLING?

3. BASIC STEPS IN RANDOMIZED CONTROLLED TRIAL ARE?

4. EXPLAIN BIAS IN RESEARCH WITH EXAMPLE?

5. DEFINE NON RANDOMIZED CONTROLLED TRAILS WITH EXAMPLE?