Types of Randomizations

By
Dr.Ahmed Mohamed Sayed Mohamed Farraj
Master of Implantology
Under supervision of:
Prof. Ahmed El-Heeny
Headmasters of pedodontics and epidemiology department
Minia University
Introduction
Clinical trials
are research studies that test how well new medical approaches work in
people Randomization is a process by which allocation of subjects to
treatment groups is done by chance, without the stability to predict who is
in what group Randomization A method based on chance alone by which
study participants are assigned to treatment group.
Randomization
Minimizes the differences among groups by equally distributing with
particular characteristics among all trial arms. The researchers don't know
which treatment is better. Need of randomization
Primary:
To prevent bias in allocating subjects to treatment groups.
Secondary:
To achieve comparability between the groups.
If, at the end of a clinical trial, a difference in outcomes occurs between
two treatment groups (say, intervention and control) possible
explanations for this difference would include: the intervention exhibits a
real effect; the outcome difference is solely due to chance there is a
systematic difference (or bias) between the groups due to factors other
than the intervention. Randomization aims to obviate the third possibility.
• Types:
• Simple random
• Systematic sample
• Stratified random sample
• Cluster sample

Simple Random Sample

• Each individual has an equal chance of being included in the sample.
The two common methods of random sampling are lottery and tables of
random numbers.
This method is equivalent to tossing a coin for each subject that enters a
trial, such as
Heads=active, trials=placebo.
The random number generator is generally used. It is simple and easy to
implement and treatment assignment is completely unpredictable.
However, imbalanced randomization can happen in smaller trials,
reducing statistical power.
e.g., in trial of 10 participants treatment effect variance for 5-5 split
relative to 7-3 split is (1/5+1/5)(1/7+1/3)=.84, so 7-3 split is only 84% as
efficient as 5-5 split.
Even if treatment is balanced at the end of a trial, it may not be balanced
at some time during the trial, for example, the trial may be balanced at the
end with 100 participants, but the first 10 might be AAAATATATA.
Systematic sampling:
• The first unit is chosen at random and then other units for the sample are
chosen in a systematic way, e.g. every other person or every fifth person.
Stratified sampling:
• The population to be sampled is divided into groups known as strata. A
simple random sample is then drawn from each stratum. If the condition
under investigation is known to be related to various factors such as; age,
sex, area of residence. For example, population divide into different age
groups and then samples are selected from the groups randomly.
An RCT may not be considered valid if it is not well balanced across
prognostic factors. E.g., age group :< 40, 41-60,>60; sex: m,f; total
number of strata=3x2=6
Stratification can balance subjects on baseline covariates, tend to produce
comparable groups with regard to certain characteristics) e.g., gender,
age, race, disease severity) thus produce valid statistical tests.
Cluster sampling:
A simple random sample is selected not from individual subjects but of
groups or clusters of individuals. For example, villages, wards, schools
children. So, it is important to calculate the sample size with a proper
power capable of answering the research question. (calculate the sample
size based on the primary outcome
Sample size calculation
 • For any study design, one of the most important questions is how many
participants we should have in the study (sample size). A study with a
small sample size will not have enough power to answer the research
question and might have a negative result and a true difference may be
missed (due to the low power). On the other side, doing a study with
more sample size than what is needed is a waste of time and resources
and may be unethical as more people are exposed to dangers and side
effects.
Requirements
• The main hypothesis of the study, The design of your study, Expected
ES, The desirable statistical power, The acceptable margin of error
(alpha), and Adjustment for loss of follow up.