Bangalore: Jostling with the game of clinical research
Vijaya K – Bangalore
Bangalore is once again in the limelight. Not just because it is the IT capital or biotech hub, but for excellent clinical research opportunities it provides. With the presence of strong intellectual base and a commitment to high ethical standards, Bangalore offers unique advantages in terms of high quality research institutes and hospitals, good infrastructure and a world class software industry.
The strength of Bangalore in clinical research is the infrastructure. In addition to maximum medical colleges in the city with all the specialities and super specialities, basic science facility at the Indian Institute of Science, drug testing labs and excellent infrastructure in the private sector for clinical research units, there are many data management facilities which are of international standards handling global data and processing.
‘‘Potential for clinical research in Bangalore is enormous,’’ feels Omprakash, manager – Regulatory Affairs & Data Management at Clinigene International, a subsidiary of Biocon India. ‘‘The diverse patient population, state-of-the-art medical infrastructure, world renowned primary, secondary and tertiary healthcare centers, IT infrastructure in place, investigators trained or accustomed to work as per GCP/ GLP guidelines, disciplined patients, around 50 per cent cost savings, good services for attaining operational and logistic competencies are some of the strengths of Bangalore,’’ he says.
‘‘However, going overboard and practicing unwarranted shortcuts so that data produced by the study is not acceptable to regulatory authorities will be a hindrance,’’ he adds. At present the total number of CROs in Bangalore can be around 10 – 15 which may grow upto around 15 – 20 in the next two to three years. Some of these include Clinigene, Lotus Labs, Icon, Clintec, PharmaNet, Omnicare Quintiles, Pharm-Olam, etc. Says Prof K M Prasanna Kumar, Dept of Endocrinology, M S Ramaiah Hospital, ‘‘The number of CROs may increase tremendously in the next five years provided we encourage and train large number of them. Clinical research is getting tougher because of stringent GCP guidelines, ethical committee requirements and lack of dedicated personal taking up clinical research as full time employment and commitment. We need at least 50 times more clinicians to take up clinical research as full time job.’’
M S Ramaiah Hospital plans to set up a central clinical research center of international standard at Bangalore with all clinical, research facility, data monitoring, storage and analysis including drug research centre. ‘‘We intend to start a Bangalore clinical research foundation and create a platform for all interested clinicians and biomedical research persons to interact and share their knowledge and expertise,’’ Prof Prasanna reveals.
CRO’s offering comprehensive range of services
The CROs are offering a comprehensive range of services like bioavailability/ bioequivalence studies, Phase I to IV clinical trials, speciality studies, non/ pre-clinical studies etc including data management. ‘‘Being IT Capital a lot of CRO’s are expected to focus in Bangalore since data management is an integral part,’’ believes V V Raghavan, managing director of Lotus Labs, a center for clinical research. Lotus Labs has signed an MoU with St John’s National Academy of Health Sciences for building activities. It also plans to enter Phase I to Phase IV activities in clinical research within the next two years. Lotus has invested approximately Rs 10 crores. ‘‘Contract Research is a capital intensive activity and investments are expected to be large,’’ he adds.
According to sources in the industry, the contribution of the Bangalore CROs is around 2.5 per cent to 3 per cent of the total Indian CRO industry estimated at Rs 350 Crores (since 2000). Looking at the growth of the CRO industry in India in all probability the contribution is expected to rise in the next 2-3 years as Bangalore provides a strategic location within India.
A CRO should have qualified, accountable, responsible and motivated faculty to conduct the study; excellent infrastructure for communication/ transportation; support services which are of international standard and with an external acceptable quality control; adequate and varied patient load representative of the surrounding population; reputation of national and international standing in terms of research potential; a functional unbiased Ethical Review Board; financial accountability and an institute dedicated to research, according to Dr Sanjiv Lewin, Associate Professor, Unit Head at the Departments of Paediatrics and Clinical Ethics, St John’s Medical College Hospital.
The Hospital is one example of tertiary referral hospitals situated in Bangalore, where clinical research is conducted in the institution to international standards with sponsors such as Ford Foundation, Mother Care, Welcome Trust, ICMR, IAEA to name a few. The Hospital has recently set up a separate Institute of Population Studies and Research with a separate faculty and Dean to stream-line most future research, especially administrative and data collection/ analysis/ interpretation, permitting clinicians to concentrate on the actual study components.
With an access to many valuable resources including investigator sites and talented industry professionals, CROs are fortunate to have speciality hospitals in the City which can provide a platform for clinical research in different therapeutic areas. Multidiscipline hospitals, well qualified & trained Clinical Investigators and heterogeneous patient population are the major strengths of Bangalore.
However, the City lacks awareness on clinical research and regulatory issues. ‘‘To an extent, I feel the infrastructure should improve. Of course, because of its location it is often expensive to conduct studies in the eastern and northern part of the country.
However, this problem can be overcome by regional clinical teams or alliances etc,’’ asserts Jeroze Dalal, manager, Clinical Operations, AstraZeneca Pharma India.
“The main reasons for initiating studies in Bangalore here are the technically competent doctors, well-equipped institutes and the availability of patients. Trials can be conducted at a faster pace and at a lower cost. This probably explains the recent spurt in the number of CROs different in their size and scale of operations. Clinical research laboratories with CAP and NABL accreditation have established their presence locally as well as there is opportunity for conducting bioequivalence studies. Indian Institute of Science, which is India’s premier scientific institution, has also spotted several opportunities in contact research both in India and abroad,’’ Jeroze explains.
For the latest entrant PharmaNet, India is an important region as the company continues its global expansion strategy throughout the Asia-Pacific Region. Says Anand Bhogu, the liaison person for the company in India, ‘‘India is growing in importance for conducting clinical trials. Through its office in Bangalore, PharmaNet is also positioned to assist Indian based companies in the development and implementation of local and Asia-Pacific-based efforts.’’
PharmaNet is committed to providing the highest possible levels of industry-leading expertise and client satisfaction. Amidst the hustle and bustle the CROs need to be on par with multinationals and international standards by adopting well defined regulatory mechanisms establishing international standards in clinical research. They should provide data which will be accepted by any international organisation and prove that we can conduct clinical research of international quality with highest recruitment rate.
The prime issue of concern is that all CRO’s need to work towards providing data of studies acceptable by global regulatory agencies. Meeting the GCP or GLP standards and other relevant country specific guidelines without any deviations would make CRO data originating from India acceptable to all regulatory agencies.
But awareness among the population has to be created to carry on clinical research and misconceptions have to be removed to make Bangalore a centre of excellence for clinical research and a home for survival of the fittest.