Clinical Research - Ikya

1
Clinical Research and Clinical Data Management
Everything You Need to Know
For More Details Visit http//www.ikyaglobaledu.ne
t/Clinical-research-trainings-hyderabad.php
2
Introduction
Clinical research is an arm of healthcare science
which decides the safety and potency of
medications, devices, diagnostic products, and
the treatment regimens that are aimed for human
use. These could be utilized for the prevention
and treatment and the diagnosis or for relieving
symptoms of a disease.   Clinical research
includes the clinical trials that are the studies
which assess the potency and the safety of the
medical devices or the drugs. The studies are
carried on according to a standard protocol that
determines what type of patient can take part,
when and how much of the treatment is
administered, what exactly is being calculated,
and the overall length of the study.
http//www.ikyaglobaledu.net/Clinical-research-tra
inings-hyderabad.php
3
Clinical Trial Phases
Clinical trials go ahead in stages going forward
for the use for patient care after the drug or
device has been exhaustively analyzed for potency
and safety. The stages of clinical trials that
every new treatment must clear to be launched
into the market include   Phase I Researchers
trial run a new drug or treatment in a small
group for the first time to measure how safe it
is, to decided a safe dosage range, and
distinguish the side effects.   Phase II The
drug or treatment is now been administered to a
large group to measure its effectiveness and to
evaluate its safety.
http//www.ikyaglobaledu.net/Clinical-research-tra
inings-hyderabad.php
4
Clinical Trial Phases
Phase III The drug or treatment is given to
large groups of people to confirm its
effectiveness, monitor side effects, compare it
to commonly used treatments, and gather
information which allows for the drug or
treatment to safely be used.   Phase IV Studies
are conducted after the drug or treatment has
been launched into the market, to collect
information on effect of the drug in different
populations and if there are any side effects
associated with the long-term use.
http//www.ikyaglobaledu.net/Clinical-research-tra
inings-hyderabad.php
5
Research Designs that are Used in Clinical
Research
There are number of research blueprints that are
utilized for clinical research that include
descriptive, exploratory, and experimental
studies.   Descriptive Research Descriptive
research takes observations about patients or
health-related status. This research usually
includes a small group of patients and intense
studies done on them to get an idea about the
content of interest. Case-studies and qualitative
research and surveys are some of the examples.
http//www.ikyaglobaledu.net/Clinical-research-tra
inings-hyderabad.php
6
Research Designs that are Used in Clinical
Research
Exploratory Research Exploratory research
examines analyses the patients or the conditions
which have not been largely examined. Exploratory
research works to clear up or determine a
problem. Many a times, associations or
relationships are sought for so as to get a
better understanding of the disease or the
disorder. For example, a study may disclose the
relationship between the lifestyle components and
the particular disease. Some of the examples are
case-control studies, cohort studies, pilot
studies, and historical research.
http//www.ikyaglobaledu.net/Clinical-research-tra
inings-hyderabad.php
7
Research Designs that are Used in Clinical
Research
Experimental Research Experimental research
calls for equating two groups of people. In
general, one of the groups gets an intervention
or treatment whereas the other group does not.
The intent of this research is to probe the
effect of the treatment. When randomisation is
used, these designs, are seen as the "gold
standard" in clinical research because this
design lets the researchers to rule out most or
maybe even all of the alternative explanations in
regard to the results. For instance, a researcher
may equate a group of patients getting a placebo
drug versus a group that is getting an
experimental drug. The two groups could be the
same at the beginning of the study. The
differences that occur at the end of the study
like betterment in the disease or disorder in the
group that is experimented can be ascribed to the
experimental drug.
http//www.ikyaglobaledu.net/Clinical-research-tra
inings-hyderabad.php
8
Research Designs that are Used in Clinical
Research
The main intent of clinical trial is to get
answers to the research question by ways of
getting data that proves of disapproves
hypothesis. The data quality that is generated
has an important part in the result of the study.
Many a time, students who do research as heard
asking questions such as, what is clinical data
management and what is its significance?
Clinical data management is a needed and
significant component of a clinical trial. All
the researchers attempt their work on CDM actions
during their research work, whether knowingly or
unknowingly. Apart from the technical areas, the
process is undertaken that involves CDM during
the research work. The actions that are involved
in CDM gives the gist of the way data is been
managed in the clinical trials.
http//www.ikyaglobaledu.net/Clinical-research-tra
inings-hyderabad.php
9
Research Designs that are Used in Clinical
Research
Clinical data management CDM can be explained
as the process of the collection and the cleaning
and the management of the subject data in
agreement with the regulatory standards. The main
aim of CDM operation is to give high-quality
information by maintaining the number of the
errors and the missing data as low as possible
and also gathering the maximum data for analysis.
In order to achieve this aim, the best practices
are taken to make sure that the data are complete
and reliable and processed correctly. This has
been made to happen with the assistance of
software applications which maintain the audit
trail and that provide easy recognition and
answer of the data variance.
http//www.ikyaglobaledu.net/Clinical-research-tra
inings-hyderabad.php
10
Research Designs that are Used in Clinical
Research
High-quality data can be defined as perfectly
precise and suited for the statistical analysis.
Specific protocol parameters should be met and
protocol requirements should be complied with.
This means that if there is a case of difference,
when the protocol specifications are not met,
then there is a possibility of taking the patient
out from the final database. It should also be
kept in mind that in certain situation the
regulatory authorities would be interested into
seeing this data. Also, it should be noted that
the data that is missing could be a cause of
concern for the clinical researchers. In
high-quality data there should be minimal or no
misses at all.
http//www.ikyaglobaledu.net/Clinical-research-tra
inings-hyderabad.php
11
Research Designs that are Used in Clinical
Research
The main intent of clinical trial is to get
answers to the research question by ways of
getting data that proves of disapproves
hypothesis. The data quality that is generated
has an important part in the result of the study.
Many a time, students who do research as heard
asking questions such as, what is clinical data
management and what is its significance?
Clinical data management is a needed and
significant component of a clinical trial. All
the researchers attempt their work on CDM actions
during their research work, whether knowingly or
unknowingly. Apart from the technical areas, the
process is undertaken that involves CDM during
the research work. The actions that are involved
in CDM gives the gist of the way data is been
managed in the clinical trials.
http//www.ikyaglobaledu.net/Clinical-research-tra
inings-hyderabad.php
12
Ikyaglobal.edu is one of the leaders in training
people in Clinical Data Management and making
them industry-ready.
http//www.ikyaglobaledu.net/Clinical-research-tra
inings-hyderabad.php
13
http//www.ikyaglobaledu.net/Clinical-research-tra
inings-hyderabad.php