Clinical research and clinical data management ikya global

Clinical Research and Clinical Data Management

Everything You Need to Know

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Introduction

Clinical research is an arm of healthcare science which decides thesafety and potency of medications, devices, diagnostic products, and thetreatment regimens that are aimed for human use. These could beutilized for the prevention and treatment and the diagnosis or forrelieving symptoms of a disease.

Clinical research includes the clinical trials that are the studies whichassess the potency and the safety of the medical devices or the drugs.The studies are carried on according to a standard protocol thatdetermines what type of patient can take part, when and how much ofthe treatment is administered, what exactly is being calculated, and theoverall length of the study.

















Clinical Trial Phases

Clinical trials go ahead in stages going forward for the use for patientcare after the drug or device has been exhaustively analyzed forpotency and safety. The stages of clinical trials that every newtreatment must clear to be launched into the market include:

Phase I: Researchers trial run a new drug or treatment in a small groupfor the first time to measure how safe it is, to decided a safe dosagerange, and distinguish the side effects.

Phase II: The drug or treatment is now been administered to a largegroup to measure its effectiveness and to evaluate its safety.









Clinical Trial Phases

Phase III: The drug or treatment is given to large groups of people toconfirm its effectiveness, monitor side effects, compare it to commonlyused treatments, and gather information which allows for the drug ortreatment to safely be used.

Phase IV: Studies are conducted after the drug or treatment has beenlaunched into the market, to collect information on effect of the drug indifferent populations and if there are any side effects associated withthe long-term use.









Research Designs that are Used in Clinical Research

There are number of research blueprints that are utilized for clinicalresearch that include descriptive, exploratory, and experimental studies.

Descriptive Research: Descriptive research takes observations aboutpatients or health-related status. This research usually includes a smallgroup of patients and intense studies done on them to get an idea aboutthe content of interest. Case-studies and qualitative research andsurveys 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 twogroups of people. In general, one of the groups gets an intervention ortreatment whereas the other group does not. The intent of this researchis to probe the effect of the treatment. When randomisation is used,these designs, are seen as the "gold standard" in clinical researchbecause this design lets the researchers to rule out most or maybe evenall of the alternative explanations in regard to the results. For instance, aresearcher may equate a group of patients getting a placebo drug versusa group that is getting an experimental drug. The two groups could bethe same at the beginning of the study. The differences that occur at theend of the study like betterment in the disease or disorder in the groupthat is experimented can be ascribed to the experimental drug.










The main intent of clinical trial is to get answers to the research questionby ways of getting data that proves of disapproves hypothesis. The dataquality that is generated has an important part in the result of the study.Many a time, students who do research as heard asking questions suchas, “what is clinical data management and what is its significance?”Clinical data management is a needed and significant component of aclinical trial. All the researchers attempt their work on CDM actionsduring their research work, whether knowingly or unknowingly. Apartfrom the technical areas, the process is undertaken that involves CDMduring the research work. The actions that are involved in CDM gives thegist of the way data is been managed in the clinical trials.










Clinical data management [CDM] can be explained as the process of thecollection and the cleaning and the management of the subject data inagreement with the regulatory standards. The main aim of CDMoperation is to give high-quality information by maintaining the numberof the errors and the missing data as low as possible and also gatheringthe maximum data for analysis. In order to achieve this aim, the bestpractices are taken to make sure that the data are complete and reliableand processed correctly. This has been made to happen with theassistance of software applications which maintain the audit trail andthat provide easy recognition and answer of the data variance.










High-quality data can be defined as perfectly precise and suited for thestatistical analysis. Specific protocol parameters should be met andprotocol requirements should be complied with. This means that if thereis a case of difference, when the protocol specifications are not met,then there is a possibility of taking the patient out from the finaldatabase. It should also be kept in mind that in certain situation theregulatory authorities would be interested into seeing this data. Also, itshould be noted that the data that is missing could be a cause ofconcern for the clinical researchers. In high-quality data there should beminimal or no misses at all.










The main intent of clinical trial is to get answers to the research questionby ways of getting data that proves of disapproves hypothesis. The dataquality that is generated has an important part in the result of the study.Many a time, students who do research as heard asking questions suchas, “what is clinical data management and what is its significance?”Clinical data management is a needed and significant component of aclinical trial. All the researchers attempt their work on CDM actionsduring their research work, whether knowingly or unknowingly. Apartfrom the technical areas, the process is undertaken that involves CDMduring the research work. The actions that are involved in CDM gives thegist of the way data is been managed in the clinical trials.









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










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Clinical research and clinical data management ikya global