It’s not just the doctor who plays a role in treating those who are sick, and help them get better. Every drug that is prescribed — even if it something as simple as an aspirin — reaches the patient only after an enormous amount of money, time, effort and manpower has been put into it to make sure that it is effective, safe and fit for human consumption. If you want to help improve medical treatment and healthcare, then clinical research could be the field for you.
Clinical research is the branch of medicine that determines the safety and effectiveness of medication, medical devices, diagnostic products and treatment for human use. It includes the study of new drugs, devices, vaccines,and other tools used to improve healthcare and medical treatment. Most of these trials are conducted before the medicine is released into the market, and also after the launch of the product, to monitor the efficacy and side-effects.
Since these drug trials involve the participation of human subjects, there are several scientific, medical, ethical and legal guidelines that need to be followed to make sure that the subjects participating in the trials get maximum benefit and safety.
All new vaccines, diagnostic products, medical devices, biotechnology products are considered new drugs, and have to undergo rigorous testing before they are launched. “Clinical trials are important since they help to predict the biological effects and toxicity of a new drug which cannot be directly extrapolated to humans due to species differences. The only way to know the actual effects of a drug in human beings is through trials. Well- designed trials, conducted based on sound scientific principles and standards (Good Clinical Practice), generate good quality data for interpretation and regulatory approval,” says Shiv Raman Dugal, Chairman, Institute of Clinical Research India (ICRI).
In India now, there is a demand for researchers, with companies conducting a majority of trials here. According to J Sudhir Pai, Managing Director of the Lotus Clinical Research Academy, the Indian market for clinical trials is growing at approximately 30 per cent annually. “India’s scientific pool, improving medical infrastructure and cost competitiveness is increasing its influence and positioning in the global scenario,” he adds.
Any student who has a BSc, B Pharm, MBBS or BDS degree can sign up for an MSc in clinical research.
Those with a degree in pharmacy, medicine, life sciences, biotechnology and bio-sciences have an advantage. Many institutes that offer courses in clinical research have screening tests and interviews to select their students. Students who complete their degrees from recognised institutes stand to earn between Rs 1.5-3 lakh as they start out. For those with a Master’s degree and relevant work experience, the starting salary is likely to be higher. The annual increments are in the range of 25-30 per cent, and there is plenty of scope for growth. “Clinical research is an industry where experience counts, thus the longer you are in this field; higher the salary you can expect,” explains Shiv Raman Dugal.
Research associate to manager
The most common entry-level position is that of a Clinical Research Associate (CRA). The CRA is responsible for planning and implementing all activities that are needed to monitor clinical trials, and ensure that good clinical practices are followed. The CRA also assists in preparing presentations.
A Biostatician performs statistical programming, and design and analysis for clinical trial projects. He/she will also have to co-ordinate, provide statistical analysis, summaries and reports of studies.
A Clinical Research Manager supervises the design and writing of protocols, case report forms and informed consent forms for clinical trials.
There are other positions too, such as Clinical Research Coordinator, Business Develop-ment Manager, Clinical Research Investigator, Clinical Data Manager etc.
Students can also be placed with IT firms which are now venturing into clinical data management, medical writing and biostatistics.
According to a recent report, the Clinical Research Industry in India is expected to touch Rs 5,000 crore by 2010, and will generate employment for 50,000 people in the next few years.
This also is one of the few industries not affected by recession or economic slump. Many pharmaceutical and clinical research organisations are increasingly choosing countries like India to conduct their clinical trials.
Those with a degree in clinical research have several options. But those in the industry say that the fulfil-ment is what makes them tick.
Courses and institutes
There are several institutes in India which have courses in Clinical Research.
*ICRI, which has campuses in Delhi, Bangalore, Ahmedabad, Mumbai, Hyderabad and Dehradun, offers a two-year, full-time Master’s course in Clinical Research with an MBA, MSc in Clinical Research, a one-year part time PG Diploma in Clinical Research, and a PhD in Clinical Research. The institute also has several diploma courses at the UG-level, including those for doctors and nurses.
*Lotus Clinical Research Academy, Bangalore, in association with Birla Institute of Technology, Ranchi offers MPharm in Clinical Research and MS in Clinical Research and Pharmacovigilance.
*The Bombay College of Pharmacy offers Bachelor’s, Master’s, and Doctoral programmes of study in Pharmaceutical Sciences.
*Cliniminds Academy for Clinical Research Training & anagement offers various courses at the PG-level.