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Understanding Randomized Control Trials

The document discusses the purpose and importance of random assignment in clinical trials, emphasizing its role in reducing selection bias and ensuring comparable baseline characteristics. It also presents examples of evaluating the effectiveness of treatments through randomized control trials, including calculations of relative risk and efficacy for vaccines and medications. The findings indicate significant reductions in disease incidence with the use of specific interventions.

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2 views6 pages

Understanding Randomized Control Trials

The document discusses the purpose and importance of random assignment in clinical trials, emphasizing its role in reducing selection bias and ensuring comparable baseline characteristics. It also presents examples of evaluating the effectiveness of treatments through randomized control trials, including calculations of relative risk and efficacy for vaccines and medications. The findings indicate significant reductions in disease incidence with the use of specific interventions.

Uploaded by

iqrashareef2468
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

Randomized Control Trials

TUTORIAL
1
The major purpose of random assignment in a clinical trial is to:
a. Help ensure that study subjects are representative of the
general population
b. Facilitate double blinding (masking)
c. Facilitate the measurement of outcome variables
d. Ensure that the study groups have comparable baseline
characteristics
e. Reduce selection bias in the allocation of treatment

e
2
An advertisement in a medical journal stated that “2,000 subjects with sore
throats were treated with our new medicine. Within 4 days, 94% were
asymptomatic.” The advertisement claims that the medicine was effective.
Based on the evidence given above, the claim:
a. Is correct
b. May be incorrect because the conclusion is not based on a rate
c. May be incorrect because of failure to recognize a long-term cohort
phenomenon
d. May be incorrect because no test of statistical significance was used
e. May be incorrect because no control or comparison group was involved

e
3

500 children were randomized into two groups of 250 each with one group
receiving influenza vaccine at 6 weeks of age and others not receiving any
vaccination. They were followed for 2 years. 20 children suffered from
influenza who were vaccinated while 40 had the disease in in those who did
not have the vaccine. Calculate Relative risk and efficacy of vaccine? Also
interpret the results.
Influenza No Influenza
Vaccine 20 230 250
No Vaccine 40 210 250
RR= a/a+b / c/c+d 60 440 500
RR= 20/2500 / 40/2500 RR=0.08/0.16= 0.5
Interpretation: Children who received the vaccine are less likely to develop influenza as
compared to those who did not receive vaccine
Efficacy= 0.16-0.08/0.16
Efficacy=0.08/0.16
Efficacy=50%
Interpretation: There was 50% reduction in diseases due to use of new vaccine
4
A recent RCT found that 29% of diabetics with coronary heart disease
treated with Pravastatin suffered a recurrent coronary event during 5
years of follow-up, while 37% of the placebo group suffered recurrent
coronary events.
What is the efficacy of using Pravastatin?

Efficacy=Rate in those who did not receive intervention-Rate in those who received the intervention
Rate in those who did not receive the intervention

Efficacy of Pravastatin: 0.37-0.29/0.37 = 22%


There was 22% reduction in suffering from a recurrent coronary event with the use of Pravastatin.
Any questions?
THANK YOU!

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