Questions

Randomised • What is a randomised controlled trial?

• Are the elements of RCTs very different from

Controlled Trials other studies?

UNIFESP
Aldemar Araujo Castro
Universidade Federal de São Paulo /
Escola Paulista de Medicina
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• What does random allocation mean?
• What is the purpose of random allocation?
• How can randomisation be achieved?
• What can be randomised in RCTs?
• Can RCTs answer all clinical questions?
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The structure of a clinical trial

What is a randomised controlled trial? Patients Intervention Outcomes

Experimental
intervention Improved

• In essence, the RCT is a study in which

Not improved
Population
people are allocated at random to of patients
with the Sample R TIME
condition
receive one of several clinical
Improved
interventions.
Comparison Not improved
intervention

Fletcher RH, Fletcher SW, Wagner EH. Clinical Epidemiology. 3rd ed., 1996.
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What is a randomised controlled trial?
• In summary, RCTs are quantitative,
comparative, controlled experiments in
which a group of investigators studies
two or more interventions in a series of
individuals who receive them in random
order.
Are the elements of RCTs very different
from other studies ?
• The random allocation to the
comparison groups
• The rationale and objectives of the
study, the research question that the
investigators hope to answer, the
methodology used to answer it, the
results of the study, and its conclusions.

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 What does random allocation mean?
• Random allocation means that all
participants have the same chance
of being assigned to each of the
study groups.
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• In other words, all RCTs
are controlled clinical
trials, but not all controlled
clinical trials are RCTs.
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What is the purpose of random allocation?
• In summary, the real value of
randomisation is that, if it is done
properly, it reduces the risk of serious
imbalance in unknown but important
factors that could influence the clinical
course of the participants. No other
study design allows investigators to
balance these unknown factors.
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• The methods for allocating participants
(‘pseudo-random’ or ‘quasi-random’)
– the date of birth (odd or even years),
– the number of their hospital records,
– the date at which they are invited to
participate in the study (odd or even
days),
– alternatively into the different study
groups.
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What is the purpose of random allocation?
• By allocating the participants randomly,
the characteristics of the participants are
likely to be similar across groups at the
start of the comparison (also called the
baseline). If this is the case, the groups
are called balanced at baseline.
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How can randomisation be achieved?
• Two rules:
– First, the rules that will govern
allocation must defined
– Second, those rules should be
followed strictly throughout the whole
study
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 How can randomisation be achieved?
• Regardless of the method chosen by the
• Flipping a coin (for studies with 2 groups)
• Rolling a die (for studies with 2 or more
groups)
• Drawing balls of different colours
• Ballots with the study group labels from a
dark bag
• Random number tables
• Computers generated sequences
investigators to generate random sequences
of allocation, the number and characteristics
of the participants allocated to each of the
study groups will probably differ (although
slightly) at any given point during the study.
To minimise these differences, investigators
can use some strategies known as restricted
(or block) randomisation or stratified
randomisation.

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Random Sampling & Random Allocation

Random Random
Population Sampling Allocation

Sample 500

R
1,000,000 1,000 N
D

500

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Can RCTs answer all clinical questions?

What can be randomised in RCTs?
• Although RCTs are considered ‘the best of
• The most frequent unit of allocation in RCTs all research designs’ or ‘the most powerful
is individual people, either patients (the most tool in modern clinical research’, they are
common) or caregivers (that is, treating not a panacea to answer all clinical
questions.
physicians or nurses).
• RCTs are the ideal study design to answer
• Sometimes, however, it is more appropriate
questions related to the effects of health
to randomise groups of people rather than care interventions which are small to
individuals (cluster randomisation). moderate.

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 Can RCTs answer all clinical questions?
A scientific study
• Any clinical manoeuvre offered to the
study participants that may have an ultimately contribute
effect on their health status (that is, only a piece of
therapeutics, prevention, rehabilitation
an enormous puzzle
strategies, screening programmes,
diagnostic tests, the setting in which
health care is provided, or educational Mulrow CD. Rationale for
models). systematic reviews. BMJ 1994
Sep 3;309(6954):597-9.

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Questions
The patient’s
circumstances
• What is a randomised controlled trial?
• Are the elements of RCTs very different from The The
patient’s
other studies? Evidences wishes
• What does random allocation mean?
• What is the purpose of random allocation? Strategies
Clinical
decisions
for
• How can randomisation be achieved? Clinical application
Practice of the
Economics
• What can be randomised in RCTs? Systematic studies Guidelines guidelines
Primary reviews
• Can RCTs answer all clinical questions? studies

Clinical audit
http://www.bmjpg.com/rct/chapter1. html
http://www.metodologia.org Technology Assessment
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Como citar:
Evidências.com
Castro AA. Randomised controlled trials
[Diapositivos de aula]. São Paulo, 2001.
Disponível em: URL:
http://www.evidencias.com/pc_rct2.PDF

www.evidencias.com Data da última modificação: 21/08/2001.

E-mail: email@evidencias.com Conflito de interesse: nenhum
Fax: (+11) 3059 0250 ramal 8952 Fonte de fomento: Universidade Federal de São Paulo
/Escola Paulista de Medicina

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