Science Graduate? Take Up Clinical Research

By Dr Mary Francis.

Clinical research is one of the few industries in India that has been unaffected, as yet, by global recessionary trends. In fact, it is possible, say experts, that given the economic pressures worldwide, India could actually gain in this field, if it were to continue with its cutting edge competition, offered at a fraction at world costs for conducting clinical trials. Even today, experts are sticking by the estimate of a $600 million growth in this industry by 2010.

With a demand estimated at 50,000 trained workers by 2010, our educational institutes are able to train less than 10,000 annually.

The only thing that seems to be putting a spanner in the success of this industry is the shortage of trained professionals. With a demand estimated at 50,000 trained workers by 2010, our educational institutes are able to train less than 10,000 annually. And while infrastructural concerns are one of the reasons, lack of awareness about this field is making the situation worse. Every science graduate should in fact, consider the attractive field of clinical research for a career once graduation is over.

Clinical research is the study of drugs and medicinal systems on humans, both patients and volunteers to find out both how safe it is as well as what its adverse effects are. It is challenging not just in its vast sphere of work, its responsibilities towards its patients, but also exciting in that this work is ultimately aimed at helping patients with better and more effective medicines, at cheaper prices.

Considering that it is a highly specialized field, a course in clinical research would help an aspirant to get a strong foothold in the industry. As it deals with the human immune system and drug management, the field is ideal for doctors and nurses, and students who have graduated with life sciences like biology, zoology, botany and pharmacy. Students with statistics and mathematics as a background, too have immense opportunities in the field as they would be in the super specialized stream of data management and analysis, which has to do with number crunching - number of patients, drugs, collation of reports and analyses before finally concluding the trial.

A diploma in clinical research will include studies on clinical research and drug development processes, internationally laid down guidelines on good clinical practices, bioavailability and bioequivalence trials and quality assurance and regulations in clinical research. Since every such project essentially includes man and resource management, time management and deadlines and attaining consensus in trials, a diploma in clinical research also offers management and communication as important modules for its students.

Two new streams of study have been introduced viz pharmacovigilence and data management. Both these subjects can be taken up as certificate courses as well.

Apart from freshers, working professionals of the pharma and biotech industries, looking for a change in work profile too could take up a course in clinical research and join the field.

With the field getting wider and needing more specialized studies, two new streams of study have been introduced viz pharmacovigilence and data management. Both these subjects are being offered as certificate courses in ICTCR.

In strict terms, Pharmacovigilence is the study of the adverse effects of a new drug, being tested.  It goes on, even once the drug is in the market and ensures that any adverse reaction, even if it is a minor one, is recorded, processed, understood and prevented. India has had an enviable position worldwide in pharmacovigilence with more companies outsourcing here, and for most careerists, this is a fulfilling field.

Career opportunities for young aspirants in pharmacovigilence will be in both the management, marketing and the executive leagues: Formulation of appropriate guidelines and operating procedures, providing and following up on the requirements of reporting, developing of case reports from all new trials to ensure that the elements of safety reporting are followed.

Careers in data management will involve working as database managers, research associates, data coordinators and statisticians, clinical data management associate, clinical data coordinator, clinical data monitor, clinical data auditor, clinical data analyst, coder, and validators. One can start with a data entry team, go on to become CDM team leaders, and directors and managers of Data Management.

Typically, a clinical research career opens oppurtunities as a clinical trial assistant (cta),clinical research associate (cra), clinical team leader, project manager, manager medical & regulatory, manager - safety / patents, manager quality assurance, medical director, associate director, clinical, associate director, projects, director (clinical operations), among many others.

With the industry beckoning bright, sincere minds and offering satisfying salary packages, there should be no looking back for the aspirant who takes on clinical research as a career and gives it his/her best shot.

Dr Mary Francis is dean and director of the International Center for Training in Clinical Research.