Set up in 2004, Institute of Clinical Research India (ICRI) is known to be the country’s first premier institute exclusively focused on specialised Clinical Research education. Currently, ICRI has its presence in five Indian cities and is planning to set up a center in London.
ICRI has recently launched its healthcare division – ‘ICRI Health’, for imparting structured management education for preparing future professionals for the emerging healthcare industry. It has recently launched post-graduate courses in Hospital Operations Management and Medical Tourism.
eHEALTH met with Shiv Raman Dugal, Chairman, ICRI, to know in depth about clinical research education in India and recent developments at ICRI.
With over 30 years of experience, Mr Dugal is the founder of the institute and has been a part of the core team since ICRI’s inception in 2003. He is an active member of many industry associations and societies and has served these bodies in various capacities in
implementing their programmes.
Q. How did ICRI come up?
A. In 2003, I was toying with the idea of starting a clinical trial business in India. In 2004, India signed the IPR treaty; and I foresaw a tremendous scope for clinical research as we had qualified health professionals, a large pool of patients, and the costs to conduct trials were relatively lower than in Europe or US.
In 2004, one of our prospective customers visited us but refused to give us any trials. Instead, they advised us to train people in clinical research, as then clinical research was not taught in the country. So, we decided to go ahead with it to get specialists for our business. It was a residential set up and teachers would come from Mumbai. We took about 20 students out of 70 for our business and the rest got placed in clinical trials firms. In the next batch, we took about 750 students as the market had opened up with the passing of Patents bill. Pharma companies started seeing potential in the Indian market because it gave them security that their products wouldn’t be copied. By the end of 2005 about 150 CROs had sprung up in the country.
Q. Can you tell us about the recent devel-opments at ICRI?
A. We have recently launched a healthcare services education division-ICRI HEALTH. It gives ICRI a wider perspective, as now along with education in clinical research it will have courses in medical tourism and hospital operations management. Though the hospital operations management is been taught in many institutes but the programmes are focused on the broad strategic areas. Most of them ignore how detailed operations in a hospital are managed. For instance, they don’t teach how to run an ICU to bring down the morality rate, or how to run a laundry. They don’t get into the small details of planning a hospital or how a bed or an equipment is to be placed. Whereas at ICRI we emphasise on highest standards of teaching detailed step by step processes in a hospital.
In the field of medical tourism ICRI is the first institute in India to introduce a course in medical tourism with a tie up with Singapore Health–a public sector healthcare institution. We are also the first to have a largest pool of faculty in Healthcare education–we have about 40 faculty members to teach medical tourism in various branches of ICRI.
What is Clinical Research?
A clinical research is a scientific study of the effects, risks, efficacy and benefits of a medicinal product. These are carried out prior to the release of the medicine in the market. These trials are undertaken at various stages and studies are conducted after the launch of a new product to monitor safety and side effects during large-scale use. Clinical trials are conducted by pharmaceutical companies or Contract Research Organizations (CRO’s) on their behalf.
A B. Sc. degree is a must to enter this field. Ideally the industry prefers science graduates in pharmacy, medicine, life sciences and bioscience but graduate or post graduate in microbiology, biotechnology, nursing, physiotherapy, dentistry, homoeopathy, ayurvedic, veterinary, science, statistics and IT are also eligible. In fact they form the majority in any clinical research institute.
Clinical Research branches off into various categories at the entry level. The most common entry-level position is that of a Clinical Res earch Associate (CRA). They can rise up to the post of Clinical Research Manger (CRM). The role of a CRMs is to supervise design and writing of protocols, case report forms and informed consent forms for clinical trials. The other posts also like Clinical Research Coordinator, Business Development Manager, Investigator (at the site where subjects are actually given the study drug), Site coordinator, Clinician (responsible for the trial from the sponsor’s end), Project manager, Data Manager, Programmer, Statistician, Medical writer etc.
Freshers can expect a pay package of 2.5 to 3 lacs or more per annum depending on the educational background. If you have a master’s degree then you can expect a higher package. However, in Clinical research experience counts so the longer you are in the field the higher the salary.
The other important development at ICRI is that for the first time we have two students enrolled in doctorate course in clinical research. Also, we are launching an Adverse Drug Reaction Center in Mumbai.
Q. Tell us about the current scenario of Clinical Research education in India?
A. In recent years hundreds of private CR institutions have mushroomed in the country. However, despite that there hasn’t been any major development in the clinical research education in India. UGC is yet to acknowledge clinical research as an approved subject.
Most of these institutions don’t have full-time programmes andfaculty. Their programs are plagiarized because there is no education material available in India. That’s one of the reasons ICRI has tied up with Cranfield University, UK, and with Singapore Health.
Q. According to a report India would require 50, 000 clinical research professional by 2010. Do you think such predictions are modest looking at the ongoing financial crisis?
A. Honestly, I was a little apprehensive about the placements this year but luckily all the students got placed well. It’s not that we alone are doing a fantastic job but it reflects that the market is doing well.
I don’t see clinical research market getting affected in the short run for the simple reason that before each medicine makes it to the market, it has to pass a lengthy approval process. So, by the time a drug reaches the stage of clinical trial a company has already invested half of the money, so the chances of backing out are very slim.
Moreover, Pharma companies are unlikely to get hit, as healthcare is a booming industry even in a recession. The other factor which takes care that the job opportunities wouldn’t thin out is the medical infrastructure, thanks to the Drug Authority of India which has played a very positive role in putting together a good structure of regulations. It gives foreign companies enough confidence that the Indian market is secure. Apart from this, low costs and easy availability of naive patients will maintain India’s position of desired destination for clinical trials.