Research in
Clinical Psychology
1. Design in Clinical Research
2. Ethics in Clinical research
Introduction
In clinical research, our aim is to design a
study, which would be able to derive a valid
and meaningful scientific conclusion using
appropriate statistical methods that can be
translated to the “real world” setting.
The conclusions derived from a
research study can either improve
health care or result in inadvertent
harm to patients.
Hence, this requires a well-designed
clinical research study that rests on a
strong foundation of a detailed
methodology and is governed by
ethical principles.
From an epidemiological standpoint, there are
two major types of clinical study designs,
1.Observational
2.experimental.
Observational studies are hypothesis-
generating studies, and they can be further
divided into descriptive and analytic.
Experimental studies
Experimental studies, on the other hand,
are hypothesis testing studies. It involves an
intervention that tests the association
between the exposure and outcome.
Each study design is different, and so it
Pediatric Investigation, Volume: 3, Issue: 4, Pages: 245-252, First published: 21 December 2019, DOI: (10.1002/ped4.12166)
Observational study designs
Observational studies ask the following
questions: what, who, where and when.
There are many study designs that fall
under the umbrella of descriptive study
designs, and they include, case reports,
Pediatric Investigation, Volume: 3, Issue: 4, Pages: 245-252, First published: 21 December 2019, DOI: (10.1002/ped4.12166)
Case reports and case series
During clinical practice, we come across a
case that is atypical or ‘out of the norm’ type of
clinical presentation. This atypical presentation
is usually described as case reports which
provides a detailed and comprehensive
description of the case.
It is one of the earliest forms of research and
provides an opportunity for the investigator to
describe the observations that make a case
unique. There are no inferences obtained and
therefore cannot be generalized to the
population which is a limitation.
Most often than not, a series of case reports
make a case series which is an atypical
presentation found in a group of patients. This
in turn poses the question for a new disease
entity and further queries the investigator to
look into mechanistic investigative
opportunities to further explore.
However, in a case series, the cases are not
Ecologic study
Ecological studies are observational studies
that provide a description of population group
characteristics. That is, it describes
characteristics to all individuals within a group.
For example, Prentice et al (2020)measured
occurrence of breast cancer and per capita
But the study does not conclude specifically
which subjects with breast cancer had a
higher dietary intake of fat. Thus, one of the
limitations with ecologic study designs is that
the characteristics are attributed to the whole
Cross-sectional study
Cross-sectional studies are study designs
used to evaluate an association between an
exposure and outcome at the same time. It
can be classified under either descriptive or
analytic, and therefore depends on the
question being answered by the
For example, a cross-sectional study design
was adopted to estimate the global need for
palliative care for children based on
representative sample of countries from all
regions of the world and all World Bank income
groups. The limitation of cross-sectional study
Case-control study
Case-control studies are study designs that
compare two groups, such as the subjects with
disease (cases) to the subjects without disease
(controls), and to look for differences in risk
factors. This study is used to study risk factors for
Pediatric Investigation, Volume: 3, Issue: 4, Pages: 245-252, First published: 21 December 2019, DOI: (10.1002/ped4.12166)
Case-control studies are also prone to
biases such as recall bias, as the
subjects are providing information based
on their memory. Hence, the subjects
with disease are likely to remember the
presence of risk factors compared to the
One of the aspects that is often overlooked is
the selection of cases and controls. It is
important to select the cases and controls
appropriately to obtain a meaningful and
scientifically sound conclusion and this can be
achieved by implementing matching.
Matching is defined by Gordis et al as ‘the
Experimental study design
The basic concept of experimental study
design is to study the effect of an
intervention. In this study design, the risk
factor/exposure of interest/treatment is
controlled by the investigator.
Therefore, these are hypothesis testing
studies and can provide the most convincing
demonstration of evidence for causality. As a
result, the design of the study requires
meticulous planning and resources to provide
an accurate result.
The experimental study design can be
classified into 2 groups, that is, controlled
(with comparison) and uncontrolled
(without comparison).
In the group without controls, the result is
Experimental study designs can be divided into 3
broad categories: clinical trial, community trial,
field trial.
Pediatric Investigation, Volume: 3, Issue: 4, Pages: 245-252, First published: 21 December 2019, DOI: (10.1002/ped4.12166)
Clinical trial
Clinical trials are also known as therapeutic
trials, which involve subjects with disease and
are placed in different treatment groups. It is
considered a gold standard approach for
epidemiological research. One of the earliest
clinical trial studies was performed by James
Lind et al in 1747 on sailors with scurvy. Lind
divided twelve scorbutic sailors into six groups
of two.
Each group received the same diet, in
addition to a quart of cider (group 1), twenty-
five drops of elixir of vitriol which is sulphuric
acid (group 2), two spoonfuls of vinegar
(group 3), half a pint of seawater (group 4),
two oranges and one lemon (group 5), and a
spicy paste plus a drink of barley water
Clinical trials can be used to evaluate
new therapies, such as new drug or new
indication, new drug combination, new
surgical procedure or device, new dosing
schedule or mode of administration, or a
new prevention therapy.
While designing a clinical trial, it is important to
select the population that is best representative
of the general population. Therefore, the results
obtained from the study can be generalized to
the population from which the sample
population was selected.
Community trial
Community trials are also known as cluster-
randomized trials, involve groups of individuals
with and without disease who are assigned to
different intervention/experiment groups. Hence,
groups of individuals from a certain area, such
as a town or city, or a certain group such as
school or college, will undergo the same
Field trial
Field trials are also known as preventive
trials, and the subjects without the disease
are placed in different preventive intervention
groups. One of the hypothetical examples for
a field trial would be to randomly assign to
Conclusion
We have discussed various clinical
research study designs in this
comprehensive review. Though there are
various designs available, one must
consider various ethical aspects of the
SUGGESTED READINGS
https://onlinelibrary.wiley.com/doi/10.1002/ped4.12166
https://research.library.gsu.edu/c.php?g=115595&p=755213
https://www.nuhs.edu/media/4133/5.1bAppraiseOverviewofS
tudyDesignsLecture.pdf
