Randomized clinical trials (RCTs) are experimental studies that assess the effectiveness of medical interventions by randomly assigning participants to experimental and control groups. They aim to reduce bias, provide robust evidence for medical decisions, and involve various randomization techniques to ensure balanced groups. Challenges include participant recruitment and maintaining engagement, which are crucial for the validity of the study's outcomes.

1. Welcome
RANDOMIZED CLINICAL TRIALS
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Sravani Yenneti
M. Pharmacy
Student ID: CLS_232/112023

2. Randomized Clinical Trials
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INTRODUCTION:
RCT’s are the experimental studies designed to
assess the effectiveness of medical interventions.
These are the studies in clinical research in
which, participants are randomly (randomized)
assigned to an experimental group or a control
group. These studies measures the effectiveness
of a new intervention or treatment.

3. Randomized Clinical Trials
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PURPOSE OF RCT’S:
 The main purpose of RCT’s is to measure the effectiveness
of a new intervention or treatment.
 These studies reduces bias and provides a rigorous tool to
examine cause-effect relationships between an intervention
and outcome.
 These studies plays a pivotal role in providing robust
evidence for medical decision-making.

4. Randomized Clinical Trials
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DESIGN OF RCT’S:
• Randomization process in clinical trials ensures that subjects
have an equal chance of being assigned to each group.
• This design helps in differentiating between control and
experimental groups, and discussing the role of blinding to
minimize bias.

5. Randomized Clinical Trials
RANDOMIZATION TECHNIQUES:
1. Simple : Complete randomness of assignment of treatment to a
particular group.
2. Stratified : Treatment and control groups are balanced on
important prognostic factors like gender, age etc., that can
influence the outcome of the study.
3. Block : Subjects are divided into blocks and randomization is
carried out in each blocks.
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6. Randomized Clinical Trials
STATISTICAL ANALYSIS:
 Null hypotheses – the intervention will have no impact on the
outcome measure.
− Outcome will be similar in both the test and control
groups
 Alternative hypotheses − intervention will have meaningful
effect and statistically significant.
 Statistical method (e.g.);
− Pre and post intervention differences = paired t-test
− Mean differences pre and post between two group =
independent test
− Mean differences pre and post between more than two
groups = ANOVA
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7. Randomized Clinical Trials
CHALLENGES IN RCT’S:
 Participant recruitment can be a significant challenge
in RCT’s. Researches may struggle to enroll a
sufficiently diverse and representative sample,
impacting the generalizability of study findings.
 Maintaining participant engagement throughout the
trial is crucial. High dropout rates can compromise the
study’s internal validity and statistical power, affecting
the reliability of results.
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8. Randomized Clinical Trials
CONCLUSION:
 As the results of a randomized clinical trial can have a
significant impact on human health and on the way
that health care is provided, it is very important to
understand the overall course of each individual
research.
 Successful RCT’s can have a profound impact on
clinical practise, shaping guidelines and improving
patient outcomes.
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9. Randomized Clinical Trials
REFERENCES:
 BJOG. Author manuscript; available in PMC 2018 Dec 1. Published in final edited
form as: BJOG. 2018 Dec; 125(13): 1716. Published online 2018 Jun
19. doi: 10.1111/1471-0528.15199
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10. ThankYou!
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