Clinical Research: Boom time for clinical researchers

The fast-track pharmaceutical and healthcare industries could morph India into a hub of clinical research which is poised to become the fastest growing sector in the life sciences

Even as the business process outsourcing (BPO) industry is utilising contemporary information communication technologies to transform India into ‘the back office of the world’, the fast-track pharmaceutical and healthcare industries could also morph India into a hub of clinical research which is poised to become the fastest growing sector in the life sciences.

“There is an immediate requirement in the Indian pharmaceutical industry of 10,000 people in the area of clinical research. India apart, internationally too there is a dearth of trained manpower in this sector. According to a McKinsey & Co report, the global clinical trials outsourcing opportunity in India is estimated at an annual billing of $2 billion (Rs.9,000 crore) by this year when the demand for clinical research professionals will rise to 50,000,” predicts the eminent Dr. S.K. Gupta, dean and director general of the Institute of Clinical Research (India) and former head of pharmacology at the All India Institute of Medical Sciences, Delhi.

Unsurprisingly, pharmaceutical companies are scrambling to sign on trained professionals whose pay packages are getting bulkier. Trained pharmacists and clinicians are required for various genres of clinical research starting from site monitoring, site management, clinical data management, data analysis, and report writing to report submission, presentation, and publication. Given the sensitivity of the process, clinical trial professionals need special academic qualifications. Graduates/postgraduates in zoology, biology, microbiology, biotechnology, botany, molecular biology, biochemistry, genetics, pharmacy, statistics, information technology, and management are eligible to enter the field of clinical research.

Apart from the Institute of Clinical Research, India (ICRI) which offers a Master’s degree, there are several other institutes in the country offering postgraduate certificate and diploma courses in clinical research. Among them are:

Bioinformatics Centre, University of Pune, offering a six-month postgraduate certificate course in clinical research and clinical data management (RCDM)
Academy for Clinical Excellence (ACE), Mumbai, offers a postgraduate diploma and several certificate courses
Vaatsalya Clinical Research Academy (VCRA), Bangalore, offers a six-month advanced diploma in clinical trails management and regulatory affairs
Manipal University, the first private deemed university recognised by the government of India, offers a diploma in clinical research and regulatory affairs
Clinical Research Educationand Management Academy (CREMA) in Mumbai, Delhi, Bangalore and Hyderabad, offering one-year and post graduate diploma in clinical research

A career as a trained clinical professional is worthy of consideration because remuneration packages are weighty. Candidates at entry level positions can earn up to Rs.8 lakh per annum rising to Rs.18 lakh per annum in five years. Business development executives can expect more than their counterparts working as clinical research associates or in data management. Abroad, salaries are sky high with more than 250,000 positions vacant globally. Therefore, pay packages vary between $40,000 (Rs.17 lakh) per annum for clinical research coordinators to $100,000 (Rs.42 lakh) for business development managers. 

“Globally there has been a paradigm shift in the pharmaceutical industry and nearly two-thirds of R&D expenditure is allocated for drug development. Of this clinical research accounts for 70 percent of the time and resources spent in drug development. The discovery of new drugs requires investments of millions of dollars with the cost of developing a new drug steadily increasing from around $200 million (Rs.900 crore) in the early nineties to over $800 million in the new millennium,” explains Gupta.

Gupta has impeccable academic and experiential credentials to comment upon the unfolding scenario in the pharmaceutical industry, and clinical research in particular. A Ph D in clinical pharmacology, DSC, FIACS, he retired as head of the pharmacology department of AIIMS in 2004. He is also president of the Indian Pharmacology Society and an emeritus professor at Indian Council of Medical Research (ICMR). Having published over 300 papers in national and international science journals, he is the recipient of the distinguished services award in medicine and surgery of the International Academy of Cardiovascular Sciences, and has also authored several pharmacology textbooks.

According to Gupta, a large and growing number of western multinational drug companies have identified India as an ideal society for clinical research. Firstly, India has numerous government funded medical and pharmaceutical institutions with state-of-the-art facilities. Secondly, India has a large, well-trained English-speaking professionally qualified workforce. Moreover, the cost of conducting clinical trials is 50–70 percent lower than in the United States or European Union.

“An additional factor behind India emerging as a favoured destination for clinical research is that alternative systems of medicines like ayurveda, unani, siddha, homeopathy are practiced with equal fervour. Thus, clinical studies for their evaluation can also be easily conducted. These are the reasons why India is attracting global collaborative contract proposals for conducting clinical trials with many front-line pharma companies setting up clinical research organisations here,” explains Gupta. Among the several clinical research organisations which have sprouted recently are DiagnoSearch; Specialty Ranbaxy Ltd; Quintiles Clinigene; Eli Lilly; Reliance Clinical Research Services; and Lotus Lab — all of whom are on a recruitment spree.

Gupta is of the opinion that clinical research is still in its infancy in India and there’s need for more capacity and capabilities in terms of education, regulatory infrastructure, and creation of a pool of specialised research investigators. To this end, in 2003 Gupta promoted the Institute of Clinical Research, India (ICRI) in Dehradun which has since established centres in most major cities of India. The institute awards a two-year Master’s degree in clinical research, regulatory affairs, and related areas. An autonomous institution, ICRI is affiliated to the Dr. MGR Deemed University in Chennai, which is approved by the ministry of HRD, government of India, and University Grants Commission. ICRI established a centre in Mumbai in December 2004, which offers a one-year postgraduate diploma programme in clinical research and trials management, open to MBBS, BAMS, BHMS, BDS, B.Pharma, Nursing, B.Sc (life sciences), clinical research and pharma professionals.

“In ICRI we combine the practical and theoretical aspects of formal education with internships of six months during the last semester of the two-year course. We need many more such training institutes. There is a huge gap between the requirement of trained personnel and the number of skilled people available,” says Gupta.

Little wonder their pay packets are becoming bulkier!