2. Clinical Research:
The National Institutes of Health [NIH] explains “clinical research” as study administered
with human subjects or on elements of human origin like specimens, tissues, etc., for
which a researcher interacts directly with human subjects. In vitro studies are not included
in this as they are not linked to a living individual.
Clinical research comprises of clinical trials, which are investigations that analyze the
efficacy and safety of medical devices or drugs. These investigations are carried out in line
with a formal protocol, which categorizes what kind of patient can participate, what is
being measured, when and how much treatment is given, and the overall duration of the
study.
Clinical Trial Phases:
Clinical trials advance in phases, making headway toward use for patient care after the
drug/device has been thoroughly studied for effectiveness and safety. The stages of clinical
trials, which each new treatment must pass to be introduced into the market include:
3. Research Techniques Used in Clinical Research:
There is numerous research techniques used for clinical research such as descriptive,
exploratory, and experimental studies.
Descriptive Research:
Descriptive research makes surveillance about patients or health-related conditions.
Usually, this investigation includes a small sample of patients and intensively studies them
to get an idea into the subject of interest. Some examples of these include qualitative
research, case-studies, surveys, etc.
Exploratory Research:
Exploratory research probes patients or conditions that have not been widely studied.
Exploratory research looks to explain or define a problem. Many a times, relationships or
associations are looked for so as to better understand a disease or disorder. For example, a
study may uncover a link between lifestyle factors and a particular disease. Examples that
include such are case-control studies, cohort studies, pilot studies, and historical research.
4. The CDM process, like a clinical trial, starts with the final product in the mind, which means
that the entire procedure is planned in keeping the deliverable in view. As a clinical trial is
projected to resolve the research question, the CDM procedure is designed to hand over
an error-free, effectual, and statistically well-grounded database. To meet this aim, the
CDM procedure begins early, even before the finalization of the study protocol.
The top 10 pharmacological companies listed in the Fortune 500 companies earn more
than the rest of the 490 companies listed! Well, that surely tells the story! The future looks
bright and promising for clinical research and clinical data management, and it would only
seem prudent to give this career a thought.
Ikyaglobal.edu is one of the leaders in training people in Clinical Data Management and
making them industry-ready.
For more information about clinical data management training visit
http://www.ikyaglobaledu.net/Clinical-data-management-trainings-hyderabad.php