OPPORTUNITIES IN CLINICAL RESEARCH

SCOPE
The Indian pharmaceutical market will experience a compounded annual growth rate of 12.3 per cent, and triple its worth to $20 billion by 2015, thus catapulting India into the world s top 10 markets.

FICCI-Ernst &Young Report

The market for Clinical Research is growing at a rapid pace. The global market is estimated to be worth over USD 52 billion. There are more than 2,50,000 positions vacant, globally with attractive salaries. In India, a prediction of more than 50,000 intakes in the Clinical Research sector is expanding every month. With a dramatic increase in the number of trials being conducted worldwide, the demand for clinical research professionals has reached an all-time high.

FICCI-Ernst &Young Report

Clinical Research is in the limelight now because the search for new drugs is constantly on. The market for research and development of these drugs is certain to grow forever, making clinical research a wise career decision for a rewarding future. Clinical Research is an organized trial of a new drug, conducted on human beings to determine its safety and efficacy. In other words Clinical research is a branch of medical 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 relief of symptoms in a disease.

What is clinical trial??

Once a treatment is tested in the laboratory, it can undergo human testing. Clinical trials are conducted in a series of four steps or phases.

What are the phases in CR

Phase 0 trials Are also known as human micro dosing studies and are designed to speed up the development of promising drugs by establishing very early on whether the drug or agent behaves in human subjects as was expected from preclinical studies. A Phase 0 study gives no data on safety or efficacy, being by definition a dose too low to cause any therapeutic effect Phase I It is the first stage of testing a new drug in healthy human volunteers. For this a small group of healthy people (20-80) is selected to test its safety tolerance, pharmacokinetics and Pharmacodynamics of a drug. Phase II The drug or treatment is given to a larger group of people (100-300) to see if it is effective, after the initial safety of the study drug has been established in phase I. This phase helps to analysis how well the drug works and helps to assess the safe dosing range.

Phases cont

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Phase III Phase III studies are performed on larger group of people (1,000-5,000) to confirm how effective the drug is and to obtain additional safety data to support marketing claims for the drug. Phase IV Phase IV known as post-marketing surveillance phase involves safety surveillance and ongoing technical support after the drug receives permission to be sold. This phase is conducted over much larger group of people and for longer duration. This trial may occur after the drug or treatment has been approved for use by the FDA.

Growth
Clinical research industries are quite attractive and growing exponentially in the past few years. It has opened large number of career opportunities to medical, pharma and all interdisciplinary fields. There are more than 360 big and small CROs in Mumbai, Delhi, Gurgaon, Hyderabad, Bangalore etc. Unlike the other industry which is completely dependent on other countries, Clinical Research Industry is not completely dependent. India has major giant Pharma companies who themselves have their own CRO establishment.

Growth cont

India is fast emerging as a sweet spot , as compared to most emerging markets, with a robust 31 % p.a growth over the last 4 yrs. Big Pharma today carry out more than 60% of clinical trials in India through their captive centres. India is ranked third among emerging markets and is growing the fastest in its number of industry sponsored phase II III sites.

Various Job opportunities in Clinical Research Industry

Here are a few options you can consider Clinical Research Associate (CRA) Clinical Research Coordinator (CRC) Investigator Scientific writer/Medical writer Biostatistician Quality Analyst (Quality Assurance and Quality Control) Data Manager Data Validation Data Entry Operator