|
Discovery of Penicillin dawned a new era of antibiotics that gave hope against life-threatening infections. Insulin has literally given a lease of life to millions of people who would otherwise have succumbed to diabetes. Such discoveries has led to a race of finding new drugs to earn fame and money.
A dark episode in the history raised serious questions about the Drug Discovery & Development (DDD) process. Thalidomide — a drug used by pregnant women — brought about an epidemic of shortening of limbs of their newborns. They had smaller bodies and rudimentary hands and feet. This and such similar alarming episodes raised concerns about drug safety all over the world. This triggered continued efforts attempting to balance risks to the subjects participating in a drug trial and the benefits that mankind would accrue by the new drug under scrutiny. Today, all over the world, the process of DDD is standardized and regulated. It addresses the social and ethical aspects of Medical Sciences putting these above the biological aspects. It is binding on all researchers to abide by the regulations at every stage of DDD. This makes Clinical Research interesting, challenging, humane and rewarding.
As a Clinical Research professional, you will be part of various drug development processes designed for improving health of the society. This emerging career also offers a lucrative salary and fast-track growth. The perfect balance of self growth as well as service towards society makes a career in Clinical Research all the more attractive.
Clinical Research simplified
Clinical Research is an organized trial of a new drug conducted on human beings to determine its safety and efficacy.
Out of the 5,000–10,000 leads screened, only 250 enter pxe-clinical testing, out of which just five enter Clinical Testing. Out of these five molecules, only one is approved by the US FDA for use in humans Source: Tufts Center for the Study of Drug Development .
Clinical Research is conducted in four phases
Phase I:
It is the first stage of testing a new drug in healthy human volunteers. A small (20-80) group of healthy volunteers are selected for Phase I research. This phase includes trials designed to assess the safety tolerance, pharmacokinetics, and pharmacodynamics of a drug.
Phase II:
Phase II trials consist of a larger group (100-300) and is carried out amongst patients/volunteers, after the initial safety of the study drug has been established in Phase I. This stage determines how well the drug works and helps to assess the dosing requirements and the drug efficacy.
|
|
Phase III:
Phase III studies are performed on large patient/volunteer groups (1,000-5,000) depending upon the kind of medical condition that is being studied. This stage is aimed at assessment of 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 the safety surveillance and ongoing technical support of a drug after it receives permission to be sold. This phase is conducted over a much larger patient population and for a longer duration than all the earlier three stages. It is designed to detect any rare or long-term adverse effects.
|
Drug Development takes approximately 15 years from basics to humans at a cost of approximately USD 1 billion. The Drug Development undergoes In-Vitro and In-Vivo processes as explained in the diagram above.
Making an impact the World over
Global pharmaceutical industry has gained an unmatched momentum the world over, making Clinical Research one of the most lucrative careers in recent times. There couldn’t be a better time for Clinical Research. The global market is estimated to be worth over USD 52 billion. There are more than 2,50,000 positions vacant with attractive salaries. And with a dramatic increase in the number of trials being conducted worldwide, the demand for Clinical Research professionals is ready to reach an all-time high.
India – At the forefront of Clinical Research revolution
India has an easy access to a large, diverse and therapy-naďve population with vast genetic diversity ready to undergo clinical trials. Also, India is home to a vast reserve of knowledge and resource base and is strategically located in the arena of global clinical research and trials. India’s potential as a favourite outsourcing destination has led many global pharma companies to set up Clinical Research businesses here.
Advantage India
Key factors contributing to India’s emergence as a hub for Clinical Research:
* Local cost of Clinical Studies – 50 to 70% of costs in the US/EU
* Fast recruitment, accelerated approvals and good communication skills
* Gigantic pool of treatment-naďve patients in major cities
* English-speaking investigators
* Regulatory facilitation of parallel phase studies
Top
|
|
