From the time India signed the TRIPS (Agreement on Trade Related Aspects of Intellectual Property Rights) Agreement with World Trade Organisation (WTO) in January 2005, the country has seen a paradigm shift from archaic lab chemistries in clinical research to very modern and structured means of drug discovery and development. Thanks to the active participation of several multinational players in the clinical research industry by setting up base in India.
Some of the facts and figures which attract clinical research organisations to India are:
■ 1 billion population
■ Birth rate: 26/1000 with a life expectancy of 60 years
■ Population density: 815 / sq mile
■ A wide spectrum of diseases with low per capita drug expenditure
■ 700,000 speciality hospital beds and over 5 million doctors
■ Rapidly increasing awareness of good clinical practice (GCP)
■ Lower costs for conducting trials vis-à-vis USA
■ Intellectual property protection from January 2005
■ A rapidly growing private healthcare sector
■ English as the mainstay language for communication
As the clinical research industry is poised to boom into a 1.5 billion dollar industry by 2010 with an approximate 2000 GCP studies to be conducted by a minimum of 50,000 clinical research professionals, the country today envisages a brewing crises for well educated and trained clinical research professionals.
There is no denying that the Industry does impart training for clinical research professionals. However, at best, this training can be termed as most inadequate for the industry's overall needs. There are several reasons for this. They include:
■ Training imparted is for specific jobs only and does not involve the entire gambit of clinical research
■ The training, for very obvious reasons, can only be for a short period of time
■ The clinical research professionals require constant monitoring by a large number of well qualified trainers. But unfortunately, the number of trainers available today is very small
■ In house, on the job training is not only a drain on the company's exchequer but also leads to a loss of working hours
■ At best, in house training can only lead to a passive acquisition of Knowledge and very subjective assessment
■ The Industry has also witnessed large scale attritions after their clinical research professionals are 'trained' as they are absorbed by competitive companies offering higher pay scales
This scenario is essentially the demand - supply gap. The solution lies only in generating skilled manpower for clinical research industry. Estimated manpower need of the CR Industry in India is 50000. If short term courses are excluded, then the capacity of all major training institutes in India does not exceed about 1000 - 1500 genuine clinical researchers who have width of knowledge that makes them "ready-to-start" the job. This also underlines acute shortage of trainers. Clinical research training is multi-disciplinary. It is not easy to find professionals, who have command over pharmacology, medical sciences, regulatory affairs and management with clinical research experience.
The pharmaceutical industry is rapidly expanding and getting busier by the day. Newer diseases have spread creating a demand for new molecules and new targets. Hence, India today has no other alternative but to ensure creation of highly structured and state-of-the-art impartation of pharmacy training to both, budding clinical research professionals and the working class clinical research professionals. Having said this, what therefore, should be the teaching method? Since the drug development centres study the effect of drugs on human beings, the curriculum should have a pharmacology foundation. The pharmacology foundation would impart knowledge on certain aspects, including:
■ How and why of a drug?
■ Fundamentals of physiology and pathology
■ Pharmacological basis of therapeutics
■ Prototype drug and newer agents
■ Pharmaceutical, pharmacological and therapeutic considerations
■ Toxicity and its management
■ Concept of specificity, selectivity and sensitivity
Feed-back from the pharma and clinical research industry has revealed certain gaps that the clinical research training whereby a typical junior clinical research assistant:
■ Does not easily relate to disciplines other than his graduation
■ Lacks the confidence to perform tasks in real life that he can describe so well in theory
■ Is not fully conversant of the entirety of the CR business process and his/ her role as a team member
■ Lacks the soft skills that are vital in human interactions; be it colleagues, superiors or subjects for clinical trial
For instance, institutes such as Clinical Research Institute (India) design the curriculum in such a way as to expose the students to total research activities and make them totally fit for career. An ideal curriculum should promote patient protection in CT, stress importance of guidelines and SOPs, anticipate problems and suggests solutions, ensure reliability and validity of experiments, address ethical issues and protocol designing apart from a host of other issues.
Such sort of curriculum would enable the students become adept at generating quality data, skilful action with SOPs and learn the value and importance of following timelines thus aiding towards lower costs of investments for drug development. Armoured with an in-depth knowledge of clinical research, any student in this country would be well equipped to satisfy the R&D requirements of any CRO across the globe, leave alone just India, thus eliminating the gap between the Industry's needs and well trained and educated professionals for an industry that is very well here to stay.
Leadership of India in a number of fields is an acknowledged fact globally. If India wants assert in clinical research there is crying need for:
■ Teaching institutes that can impart international grade training
■ Standardization of curriculum for entry level CRA
■ Clinical research industry getting involved in training aspects - hands on experience, talent search, scholarships
■ Public-private partnerships (FDA, GoI, AICTE, ICMR, AYUSH, pharma industry and teaching institutes). These can be facilitated by bodies like ISCR, IDMA, OPPI etc
Clinical research organisations need to consider growth, expansion in activities, geographical expansion (even beyond India) and backward integration like drug discovery.
We are living in exciting times. Whether a life science graduate or a humble BA/BE lab - the opportunities are thumping our doors. In a competitive global economy, it is the early birds who gain the most.
(The author is managing director of Clinical Research Institute (India), Mumbai)