Clinical Research and Clinical Data Management

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.

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 analysed 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.

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.

The 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.

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.

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.

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.

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.

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. It is very important that the high-quality data should have only an discretional level of variation that is acceptable and this should not

impact the end of the study on the statistical analysis. Also, the data should comply with the

applicable regulatory needs that are specified for data quality.

Ikyaglobal.edu is one of the leaders in training people in Clinical Data Management and making them

industry-ready.