1. Clinical trial study design 2. Cohort Study design 3. Case-Control Studies 4. Cross-Sectional Studies 5. Ecological Studies 6. Randomized Clinical Trials Continue Reading: https://bit.ly/3tDt6rH Reference: https://pubrica.com/services/research-services/experimental-design/ Why Pubrica: When you order our services, We promise you the following – Plagiarism free | always on Time | 24*7 customer support | Written to international Standard | Unlimited Revisions support | Medical writing Expert | Publication Support | Biostatistical experts | High-quality Subject Matter Experts.   Contact us:      Web: https://pubrica.com/  Blog: https://pubrica.com/academy/  Email: sales@pubrica.com  WhatsApp : +91 9884350006  United Kingdom: +44- 74248 10299

1. Copyright © 2021 pubrica. All rights reserved 1
Epidemiology Designs for Clinical Trials
Dr. Nancy Agnes, Head,
Technical Operations, Pubrica
sales@pubrica.com
Keywords:
Investigational New Drug Application,
post-marketing observation, cross-sectional
studies, human preliminaries, anticancer
medications
I. INTRODUCTION
Choosing the best accessible preventive and
therapeutic measures to evade disability and
passing is a significant objective as far as
wellbeing might be concerned specialists.
To accomplish this objective, we need to
perform considers that decide the estimation
of these actions. Epidemiology research
alludes to examining ailment, infections, and
causative reasons in population;
epidemiology fills in as the highest quality
level of population health appraisal.
Accessory, cross-sectional, and case-control
considers are out and out demonstrated as
observational investigations. Consistently
these studies are the fundamental
commonsense strategy for thinking about
various issues. A clinical preliminary's vital
place is exploring the distinction of the
patient gatherings caused exclusively by the
treatment strategies that are applied.
II. CLINICAL TRIAL STUDY DESIGN
Our goal in clinical research is to design a
study that will enable us to draw a true and
significant scientific conclusion using
statistical methods that can be applied in a
“real world” environment. Before deciding
on a research design, one must first define
the study's goals and objectives, as well as
choose a target population that is
representative of the population being
studied. The findings of a research study can
either enhance health care or cause damage
to patients inadvertently. As a result, a well-
designed clinical research study with a
strong foundation of comprehensive
methodology and adherence to ethical
standards is required.
 From an epidemiological perspective,
there are two most important types of
clinical study designs, Observational
study design and Experimental study
design.
 Observational studies are hypothesis‐
generating studies, and they can be again
divided into descriptive studies and
analytic studies.
 Descriptive observational studies
describe the exposure and/or the
outcome, while analytic observational
studies assess the relationship between
the exposure and the outcome.
 Hypothesis research studies, on the other
hand, are experimental studies. It entails
a procedure for determining whether
there is a connection between the
exposure and the outcome.
 Each study design is distinct, and so it
would be critical to choose a design that
would most properly answer the

2. Copyright © 2021 pubrica. All rights reserved 2
question and provide the most useful
information. We will be reviewing each
study design in detail.
III. OBSERVATIONAL STUDY DESIGNS
Cohort Study design
Patients in cohort studies are initially
divided into two classes based on their
contact status. The Cohorts are followed
over time to see who in the exposed and
non-exposed classes develops the disease.
Retrospective or prospective cohort studies
are both possible. In contrast to a case-
control study, which starts with diseased and
non-diseased patients, a cohort study starts
with exposed and unexposed patients,
allowing for direct calculation of incidence.
A cohort study's impact is calculated using
relative risk. Recall bias is very minimal in
cohort studies, and many results can be
studied at the same time. Cohort studies
have the drawback of being more
susceptible to selection bias. Cohort research
can be very costly and time-consuming
when researching rare diseases and results
with long follow-up periods.
Case-Control Studies
Contrasted with the cohort and cross-
sectional studies, case-control considers are
generally retrospective. Case-control
contemplates easy to arrange and
reflectively contrast two gatherings with
discovering the indicators of a result. Grant
appraisal of the impact of indicators on the
result utilizing the count of a chances
proportion.
Cross-Sectional Studies
Cross-sectional studies are retrospective and
include a snapshot of the research subjects'
characteristics at a specific point in time.
Cross-sectional studies, unlike cohort
studies, do not require a follow-up period
and are thus relatively easy to perform. The
weakest of the observational designs, cross-
sectional research design, cannot include
cause-effect relationships. The exposure
status and result of interest information are
obtained in a single moment in time, often
through surveys. This method is often used
to define the prevalence of a disease in a
population.

3. Copyright © 2021 pubrica. All rights reserved 3
Ecological Studies
Data at the person level is inaccessible, or
large-scale comparisons are needed to
investigate the population-level impact of
exposures on a disease condition. Ecological
studies are used. As a consequence,
ecological research findings are only valid at
the community level. In ecological studies,
the types of measures used are aggregates of
individual-level data. As a result, these
studies are prone to a form of confounding
known as an ecological fallacy, which arises
when associations found in group data are
presumed to hold for individuals. In public
health science, ecological experiments are
commonly used.
IV. EXPERIMENTAL STUDY DESIGNS
Randomized Clinical Trials
The gold standard in clinical research design
is randomized clinical trials, also known as
randomized control trials (RCT). In an RCT,
the participants are randomly assigned to
one of two groups: control or experimental.
Randomization eliminates confounding and
reduces selection bias in RCTs. This allows
the researcher to establish identical
experimental and control groups, allowing
them to isolate the intervention's influence.
The experimental group is exposed
to/treated with a drug that may involve the
cause, prevention, or treatment of a disease.
The groups are then followed in the future to
see who develops the desired outcome.
RCTs are costly, and researchers who use
this study often encounter problems with
randomization integrity due to refusals,
dropouts, crossovers, and non-compliance.
V. CONCLUSION
There are numerous potential wellsprings of
errors that can bring about distortions of
study results. These bends are an issue,
particularly when the disease transmission
specialist assesses the relationship between a
risk factor and a medical condition. Whether
a risk factor or a defensive factor goes
undetected, or typical conduct or condition
is misidentified as a risk or defensive factor,
the ramifications may bring genuine
ramifications for general society. A
mistakenly recognized danger component
may cause superfluous dread among people,
or perhaps an unnecessary redirection of the
restricted investigation reserves. Disease
transmission specialists leading
observational examinations (cohort, go-
sectional, and specifically case-control
should be aware of predispositions' ability
and apply extra consideration to eliminate or
cut their result. As a translator of reports,
we, the overall population, must be aware of
the suitable predispositions in such reviews
after we outline their decisions as
recommended by the mass communications.
Contact Pubrica for any clinical product
development services.
REFERENCES
1. Chidambaram, A. G., & Josephson, M. (2019).
Clinical research study designs: The
essentials. Pediatric Investigation, 3(4), 245-252.
2. Puljak, L., Makaric, Z. L., Buljan, I., & Pieper, D.
(2020). What is a meta-epidemiological study?
Analysis of published literature indicated
heterogeneous study designs and definitions. Journal
of comparative effectiveness research, 9(7), 497-508.
3. https://www.researchgate.net/publication/312546983_
Epidemiology_Concepts_for_Clinical_Trials/link/5bc
af5b392851cae21b49c18/download
4. Rezigalla, A. A. (2020). Observational study designs:
Synopsis for selecting an appropriate study
design. Cureus, 12(1).