Clinical Research India Primer

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: Up until 2005, India was probably best known in the world of pharmaceuticals as a generic powerhouse. Due to poor laws around intellectual property, most multi-national biopharmaceutical companies did not seriously consider India as a destination for clinical trials. Numerous other challenges and roadblocks existed as well. But as the Industry began to globalize rapidly throughout the 90s and early part of this decade, regulators, entrepreneurs and businesses began to recognize the significant economic opportunity that they were facing, as well as the opportunity to gain new credibility in the world of medicine, science and the international business community. The response was a profound and rapid change in the regulatory landscape related to research and intellectual property that has created an inviting market which is realizing true and sustained growth.
So what is the regulatory environment today and where does it need to go?
The regulatory environment has improved dramatically in a short time period, with development of a standardized and predictable regulatory review and approval process. There are a growing number of FDA compliant IRBs. To some degree the process can be even better than other parts of the world in that conditional IRB approval can precede Ministry of Health approval. Regulatory approval timelines are also very reasonable and because sites are largely new to clinical research or dont have established business practices related to clinical research, PI and site contracts can take as little as 3-5 weeks. A Regulatory Affairs CRO India a> can assist global biopharmaceutical companies with effectively planning and placing their clinical trials in India.
A look at 1572 filings the form an investigator needs to submit in order to participate in a US IND study shows that a rapidly growing number of investigators are from India, far outnumber growth rates seen in other Asia-pacific regions such as China, Japan and Australia. Sponsors are finding that the regulatory timelines, data quality, costs and abundance of patients make India one of the most attractive countries in the Eastern world to run their studies.
The attractive aspects of the market are translating to a growth spurt in the number of studies taking place in India. An analysis conducted by Excel Life Sciences has identified a minimum of nearly 900 clinical trials taking place in India today, a number that is growing by double digits annually. This figure doesnt take into account non US IND studies, investigator initiated studies and other studies taking place.
The well known consulting firm AT Kearney ranked the attractiveness of markets across the world using the US market as the benchmark. India ranks second only to China on that scale and other than population size ranks very closely to or better than China in a number of categories, including perhaps most importantly to many companies, the regulatory environment and timelines.
Epidemiology
Like many diseases in India, given the size of the patient population and lack of standardized healthcare, disease prevalence is often much higher than other regions of the world and many of the patients are treatment nave. These factors typically result in shortened enrollment timelines and naturally reduced costs.
If you look at the breakout, it reflects those therapeutic areas made up of conditions that are most prevalent in India. These conditions to some degree represent the evolving and improving socioeconomic status of India essentially lifestyle diseases, e.g. Cardiovascular conditions, Diabetes and other endocrinology conditions, as well as many types of cancer. For example:
Oncology/Cancer
Today there are an estimated 2.5M people in India suffering from cancer and that number is expected to grow significantly in the months and years ahead driven by strong growth in tobacco related cancers, as well as those that are environmentally driven as India continues to develop rapidly from an economic and lifestyle perspective. An Oncology CRO India a> can assist sponsors with finding and screening these patients for their clinical trials.
Cardiovascular Diseases
The overall incidence of heart disease has doubled in India during the last 20 years and this trend is expected to continue. The World Health Organization (WHO) estimates that 60% of the world's cardiac patients will be Indian by 2010. Our statistics show that between the years 2003 and 2006, top sites in India saw over 100,000 patients. A Cardiology CRO India may be used by a global biopharmaceutical company to identify and enroll these patients in a clinical trial.
Endocrine and Metabolic Disorders
An estimated 108 million people in India suffer from endocrine and metabolic disorders. Diabetes is the most prevalent disease in this therapeutic area with approximately 35.5 million cases. Our clinical investigators have experience conducting global trials and have access to a large and diverse treatment naive patient pool. In fact, these investigators see 400 - 500 new cases per month and provide treatment for approximately 2,000 ongoing cases per month. An Endocrinology CRO India and Diabetes CRO India like Excel Life Sciences can assist global biopharmaceutical companies with identifying and enrolling the right patients for their clinical trials.
Neurology
India has a high prevalence for neurological and psychiatric diseases and disorders. Our statistics show that between the years 2003 to 2006 some of the leading sites in India saw over 30,000 psychiatry and over 40,000 neurology patients respectively. Although many people are already being treated, the majority are not. The World Health Organization (WHO) estimates that at minimum, an additional 25 million people in India are in need of mental health services. A Neurology CRO India a> or Neuropsychiatry CRO India like Excel Life Sciences can assist global biotech and pharmaceutical companies with identifying the right Neurology patients for their clinical trials.

About the Author:
Petter Martine is the author of this article. He has been writing articles on Clinical Trials India since last three years.



Article Originally Published On: http://www.articlesnatch.com


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