Clinical research industry globally is under pressure with a  serious shortage of trained personnel to handle patient trials. On similar lines, India too which is a recognized hub for human studies besides high-end clinical research assignments like pharmacovigilance, medical writing and clinical data management for the companies in the US and UK requires around 25,000 qualified and quality professionals annually. Current candidate supply for clinical  research industry  in India is just around 2,500.

While on the one hand, there is a shortage and a high turnover in the clinical research industry,  there is also a significant  dearth of right trained people across global markets  Candidates stick on the  job anywhere between 18-24 months going by the profusion of opportunities abroad in research not just in the pharma-biotech industry but also in hospitals and universities. Globally clinical research education is a university driven and not like India where  independent training centres impart  courses.

As India is fast becoming a hub for clinical research, the demand for professionals in this field is growing rapidly. There will soon be a massive demand for clinical research professionals, making it an interesting career option with massive growth potential.

With clinical research industry in India estimated at Rs, 5,000 crore according to the Ma Foi Report,  western world is looking at confident  competent and  candidates who could only sustain strongly in the domain of clinical research. There is a serious need to  hone skills in teamwork, negotiation, interpersonal communication, conflict management, technical expertise and people management. There is a major  shortage in the trained skilled professionals in the area of clinical research, said clinical research organizations in Karnataka.

A visible trend globally  is the emergence of biotech drug delivery technologies like intelligent patches:  Flu Patch and inhalers, oral  insulin. This segment would grow faster than drug development.   Another area of employment  globally comes in from Regulatory departments which are also scouting for professionals with a deep understanding of the industry and  ability to take independent decisions at a faster pace.   All these openings are indicating acute shortage of trained personnel and require readily available qualified-quality candidates, according to Joan Houghton, Senior Lecturer in Clinical Research, Cranfield Health, Cranfield University, UK.

The image of India has changed drastically in the last 10 years. Now the nation is  looked upon as a land of opportunities. Our concern is to live up to it. This is possible only when we address training in a big way to produce  quality human resources. But there are problems like poverty, illiteracy, population which are not letting us develop in the speed that we are actually capable of. We are trying to do in two years what was not done in the last 40  years.

In doing so we have to answer some critical questions  like where human resources are going to come from and when will our students have a good exposure and many more, said Prof. G Padmanabhan, scientist emeritus and former director, Indian Institute of Science, Bangalore.

“India is a country which can excel in every service sector. Today there is a huge shift as R&D has become a difficult proposition since the R&D budget will be cut down.

In the mid 90s almost all major pharma companies in the US & Europe were buoyant with their success with “first in class” life style and important disease tackling drugs which in-turn created a demand for more R&D capabilities.

 Standard CROs in the US like AMRI, Pharmacopea, Affymax etc were more keen on building relationship on the basis of “novel technology platform” attractiveness which steadily diminished throughout the late 90s, said  Dr. Goutam Das, Life Sciences Consultant, Goutam Das Consultancy.

 “Asian CROs came up with a novel concept of offering services at a highly affordable cost with no IP rights attached, especially following Y2K IT service model with certain necessary variation to suit pharma R&D needs,”he added.

Around US $22 billion were spent for the drug discovery in the year 2001 out of which US $2  billion  were outsourced which is only nine per cent. However in 2009, US $34 billion  were spent out of which US $7  billion was outsourced which is 21 per cent and this is a huge jump, Dr. Das  observed  adding that the  total Indian market shares could be within 2-5 per cent  of the global outsourcing business and much of its was in the chemistry related R&D space.

Clinical research offers a lot of opportunities  to Indian science graduates. Any medical graduate or a graduate with life sciences or pharmacology who is armed with a diploma from a good clinical research institute has the potential to join the field and earn much more than his counterparts from other industries.

A clinical researcher’s job entails the effect of drugs on human beings. There are several stages in clinical research, the purpose of which is to prioritise the safety of drugs. In the first phase, the testing is done on healthy human beings. In the second and third phases, the efficacy of the new drug is tested as compared to other drugs or placebos. After all these studies are conducted, a drug may be given an authorisation. However, the research does not stop here. Trials and post-marketing surveillance continue. These are done to highlight the rare side effects that the drug may have on some.

Undergraduate and postgraduate degree holders in life sciences, including nursing, physiology, biochemistry, molecular biology or pharmacy, are eligible for entry-level positions in clinical research. Courses in various institutes range from six months to one year.