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Introduction to Clinical Research

Clinical Research is a most knowledge intensive and interesting field in pharmaceutical industry. The billion dollar industry is demanding the employment opportunities of qualified and trained professionals in clinical research sector.

What is clinical research?

Clinical research is a branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical research evidence is collected to establish a treatment for particular disease.
Clinical research aims to advance medical knowledge by studying people, either through direct interaction or through the collection and analysis of blood, tissues, or other samples

Types of Clinical Research

The clinical research is categorized into two types mainly

1. Comparative Clinical Research
It is also known as controlled clinical trial. The research participants are divided into two group’s one group receives the investigational treatment, while another group either records the conventional (traditional) treatment or nothing. The control group might be given a fake treatment. This is an idle pill, injection or implantation that seems similar to the investigational treatment. The treatment conducted is kept confidential that means patient and physician both are unaware that who is acquiring the investigational treatment.

2. Open Label Clinical Research
In this type the patient and physician both know that the investigational treatment is going to conduct.

Phases of Clinical Research Trial

There are main phases of clinical trials: Phase I, Phase II, Phase III and Phase IV. The four phases of the drug approval process are separate clinical trials, and the entire process typically takes eight to 10 years.

Phase I
In this phase the first drug treatment is carried out on a small group of people. Investigator or a scientist figure out the drug’s safety, determine a safe dosage range and analyze its side effects.

Phase II
In phase II same procedure is followed as phase one but the treatment is carried out for the large number of people to observe its behavior and safety.

Phase III

The drug treatment is conducted for larger group of people. In this phase scientists or observer confirms effectiveness of a drug on particular disease, monitors its side effects, compare with traditional treatments and gathers all the information about the experiment so that the drug is been used safely in future.

Phase IV
Phase four deals with the post marketing studies that are conducted after a treatment will be approved for commercial use by FDA. Post marketing study includes all the required information about the drug along with its hazards, profits and best usage.

Clinical Data Management (CDM) System

Clinical Data Management is a system or a tool that includes overall data generated in clinical trials of particular medicine. CDM is collection, integration, validation of clinical trial data. In clinical trial investigators collect data on patient’s response to particular drug for a defined period. This data is then forwarded to the sponsor to analyze it using statistical analysis.

Types of Clinical Data

Clinical data is a staple resource for most health and medical research. Clinical data is either collected during the course of ongoing patient care or as part of a formal clinical trial program. Clinical data management system falls into following types
Electronic health records
Administrative data
Claims data
Let us discuss them one by one
Electronic health records
It is type of clinical data obtained at hospitals, health care centers, or in clinics. The data can be prescription of drugs, laboratory tests, psychological monitoring data, diagnosis, treatment and patients insurance. It is also referred as the electronic medical record-EMR of clinical data management system; it is not available for outside researchers.
Administrative Data
Administrative data is often with electronic health record, and these are non-clinical research data focused on record-keeping surrounding a service, such as hospital discharge information.
Claims Data
As the name resembles it includes data regarding insurance claim. It includes billable interactions between the patients and insurance company. This data is again subdivided into four general categories as inpatient, outpatient, pharmacy and enrollment.
Steps of Clinical Data

Clinical data collection is very challenging and innovative task in clinical research. The clinical data generates at various stages and its maintenance is becoming a crucial task for Clinical data management professional’s clinical data is generated at various stages from its designing to presentation.

The clinical data is generated at following stages

Data Design
Data collection
Data Entry
data Validation
Data Cleanup
Data Analysis
Data Reporting
Data Presentation.

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