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IPHCR research centre set up at Bangalore, CREATE trial for acute myocardial infarction underway
Nandita Vijay, Bangalore | Friday, August 8, 2003, 08:00 Hrs  [IST]

Institute of Population Health and Clinical Research (IPHCR) has been set up at St. John's National Academy of Medical Sciences, Bangalore. The Research Institute as part of a large medical college and hospital dedicated to research relevant to developing countries is being established for the first time in the country. The research institute will be housed in a 20,000 sq. ft. complex being built at a cost of Rs. 4 crore (Rs.2 crore for the building and Rs.2 crore for equipment) on the campus of St. John's National Academy of Medical Sciences.

The IPHCR has five divisions namely Clinical Research, Nutrition, Epidemiological, Health Informatics and Humanities. Already, a large number of projects are underway at the National Academy and the new Institute will provide a more formal structure and world-class facilities under one roof to further enhance the quality of the output, Dr. Anura V Kurpad, Dean, IPHCR, told Pharmabiz.com.

The additional strengths of IPHCR are genomic research, biomarkers, pharmaco-genetics, nutrition and microbiology. A health content on evidence-based medicine for the common man, database on nutrition and a registry on occupational diseases are being developed. In addition, Triesta BioSciences, a privately owned clinical genomics company based in Menlo Park, CA and Bangalore, is developing bio markers and a software to link up genomic research with Bioinformatics, informed Dr. Kurpad.

There are several clinical trials currently being done in cardiology, neurology, respiratory medicine, psychiatry, infectious disease and critical care.

The largest being CREATE (Clinical trial of Reviparin & mEtabolic modulation in Acute myocardial infraction Treatment and Evaluation) Study that is evaluating two treatments [2x2 factorial design] to improve the outcomes in acute myocardial infarction.

The trial that is being run at 69 hospitals in India, which has already recruited 4,750 subjects, is, perhaps the largest trial to date in South Asia, according to Dr. Denis Xavier, Coordinator, Clinical Trials Division, IPHCR and Assistant Professor, Department of Pharmacology, St. John's National Academy of Health Sciences.

The study began on January 3, 2002 and is likely to close in June 30, 2004 after recruiting 8,000 subjects in India. The target for the multinational trial is 20,000 to 22,000. The global coordination is done from McMaster University, Canada with Dr. Salim Yusuf heading a team of researchers. The trial team has around 250-300 medical professionals all over the country with 10 regional co-coordinators from Bangalore, Kochi, Hyderabad, Chennai, Mumbai, Nagpur, Kolkata, New Delhi, Ludhiana, and Jaipur. Again, for the first time that this many medical professional have come together in the country to conduct clinical research.

CREATE is a classic example of a large simple trial, being conducted in a variety of health facilities ranging from nursing homes to government hospitals and hi-tech tertiary centers. The advantage of a large trial is that the statistical analysis becomes more meaningful and small differences in treatment can be detected, informed Dr. Xavier.

A Registry in acute coronary syndrome is also being run from this division and has so far included over 13,800 subjects from 81 hospitals with a target of 30,000 over a period of 5 years. This is already the largest database in the subject from any developing country and the results of this study has the potential to improve how such patients are treated in future and perhaps also influence policy decisions at the Government level.

The other international trials being done are in stroke, perioperative ischemia, unstable angina and a few projects each in respiratory medicine, psychiatry, oncology, critical care and infectious disease. Also projects in collaboration with the WHO (World health Organization), ICMR (Indian Council of Medical Research), CDC (Centre for Disease Control), Atlanta are in different stages of completion.

St. John's was short-listed for the trials because of its excellent network with leading Universities like McMaster, MIT, Oxford, Harvard, London School of Tropical Medicine and Hygiene, Royal Perth and Minnesota, apart from its internationally recognized faculty with a track record in Clinical Research.

The Division of Clinical Trials is headed by Prof Prem Pais, and coordinated by Dr. Denis Xavier. The division has immediate plans for enhancing data management, complete solutions for statistical issues and to double the number of its projects in the next 3 years.

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