Randomized Clinical Trials

Welcome
Randomized Clinical Trials
G.Naga malleshwari
B. Pharmacy
Student ID – 182/092023
30/9/2023
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Contents
 Introduction
 Importance
 Steps in RCT
 -Protocol design
 -Selecting reference and experimental population
 -Randomization
 -Intervention
 -Follow up
 -Assessment of outcome
 Types of RCT
 Conclusion
 References
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INRODUCTION
DEFINITION:
“An epidemiological experiment in which subjects in a population are randomly
allocated into groups usually called study and control groups to receive and not receive
an experimental prevention or therapeutic procedure, maneuver, or intervention”.
- John M. Last, 2001
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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. (Stedman’s
medical dictionary)
 The RCT is one of the simplest and most powerful tools in
clinical research.
 To provide high-quality evidence for decision-making in
healthcare
History

Importance of randomized clinical trials
• Gold Standard: RCTs are considered the gold
standard for evaluating the effectiveness of medical
interventions.
• Evidence-Based Medicine: They form the basis for
evidence-based medical practice.
• Regulatory Approval: RCTs often play a crucial
role in gaining regulatory approval for new
treatments.
• Improved Patient Care: RCTs lead to improved
patient outcomes and healthcare decision-making.
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Steps in conducting a RCT
Designing a protocol
Selecting reference and experimental population
Randomization
Manipulation and Intervention
Follow up
Assessment of outcome
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Designing a protocol
-Aims and objectives of the study
-Research Questions to be answered
-Criteria for selection, Sample size, Procedure
for allocation of study and control groups
-Patient consent, adverse events
-Treatments to be applied
-Responsibilities of people involved in trial
 Once a protocol as been made its should be
strictly adhered
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Selecting reference and experimental
population
 Reference or target population: population to which the
findings of trial, if found successful, are expected to be
applicable(eg. Drugs, vaccines, or any other procedures)
 Experimental or study population: actual population that
participates in the experimental study
Criteria – must give informed consent
-eligible for the trial
-belong to reference population
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Randomization
• Procedure; participants are allocated into study and control groups
• It is done to Eliminates bias and allows comparability
• Both groups should be alike with regards to certain variables that might affect the
outcome of the experiment
• Best done by using table of random numbers
Methods of randomization should always be reported(CONSORT).
Types:
Stratified - randomly assigning participants to treatment groups based on predefined
and objective characteristics
Blocked –participants are randomly assigned to treatment groups in small blocks of
four or six participants
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Manipulation/ Intervention
 Having formed the study and control groups, the next step is
to manipulate the study groups by withdrawal or reduction of
the suspected causal factor (eg: this may be drug, vaccine
etc.) as laid down in the protocol
 It creates an independent variable
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Follow up
Implies examination of the experimental and control group
subjects
-at defined intervals of time,
-in a standard manner, with equal intensity, under the same given
circumstances
Attrition: some loses to follow up are inevitable due to factors like
death, migration or loss or interest
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Assessment of results
Positive results- benefits such as incidence or severity of disease
Negative results- severity and frequency of side effects,
complications , including death
 Biases: subject variation, observer bias, evaluation bias
Can be minimized by blinding
o Single blind trial –participants is not aware whether he
belongs to study or control group
o Double blind trial – neither the participant nor the
investigator is aware
o Triple blind trial –the participant, investigator and person
analyzing data all are blind
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Types of randomized clinical trials
Clinical trials
-immunization, drug treatment
Preventive trials
-vaccine trials
Risk factor trials
-control of BP in preventing CHD
Cessation experiments
-smoking and lung cancer
Trial of etiological agents
-retrolental fibroplasia
Evaluation of health services
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Conclusion
 Randomization is the heart of Randomized clinical trials.
 RCT is a gold standard in terms of identifying causality.
 Provides the strongest evidence.
 Randomization is an attempt to eliminate bias and allow for
comparability.
 Randomization is useful in hiding the knowledge of particular
treatment (blinding).
 Applications- evaluation of treatment, prevention and health
care services.
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References
 Park’s textbook of preventive and social medicine, park.
K.
 Leon Gordis. Epidemiology. Elseiver: 2004
 Wikipedia
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Thank You!
www.clinosol.com
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