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Global Pharmaceutical companies based in developed countries are increasingly turning to developing countries and emerging economies around the world for conducting clinical trials. Reduced costs combined with easy availability of patients with varied diseases makes developing countries favourite destinations for clinical research outsourcing.
According to US government publications, today, 8.9% of clinical trials registered with US health authorities are conducted in emerging countries of Asia -- 7.4% in Latin America, 7.1% in Central and Eastern Europe and 1.6% in Africa.
With 429 clinical trials currently being carried out in the country, Mexico stands out as the most attractive destination for clinical trials outsourcing. Taiwan comes second with 406 trials followed by Poland, Lebanon and Brazil, where 200, 193 and 161 trials are respectively being carried out.
A large native patient population pool, various disease profiles and robust infrastructure position India high on the outsourcing list. Today, 122 clinical trials are being conducted in India. GlaxoSmithKline, among the world's top ten global pharma majors, is currently carrying out the largest number of clinical trials in India.
Apart from the development of vaccines, the UK-based pharma major is conducting 13 drug trials in India for the treatment of diseases such as cancer, arthritis, epilepsy, heart disease and constipation. These trials include phase II, III as well as phase IV clinical drug trials.
AstraZeneca is another global pharma company outsourcing a significant number of its trials to India. Out of the 186 clinical trials the company is at the moment conducting worldwide, about nine have investigation centres in India.
These studies include drug trials for schizophrenia, bipolar disorder, cancer, diabetes and testotoxicosis and are conducted on adults and, in certain cases, children.
Likewise, Johnson & Johnson and Eli Lilly are conducting respectively eight studies in India, while seven drugs trials are lead by Pfizer. Sanofi-Aventis, Merck, Wyeth, Bristol-Myers Squibb and Roche also count among the list of companies conducting clinical research here.
To understand why developing countries have become a hot spot for clinical research, one needs to look at the drug development process in totality. This process, which starts in the research labs and ends with a drug being launched in the market, is not only time consuming; it is also extremely expensive.
The cost of drug development is estimated at $1bn, and clinical trials on humans -- a critical phase in new drug development -- account for 40% of the total cost.
Outsourcing clinical research to developing countries can allow global pharma companies to considerably trim costs. Clinical trials in India, for instance, cost 50% to 60% less than the average cost in the US.
But more than cost, time is a crucial factor for pharma companies. Considering the fact that a patent lasts 20 years, starting from the moment the drug is discovered and approved for clinical trials, more than half of the time is already gone by the time the trials are over and the drug is finally marketed.
Indeed, clinical trials alone can last up to 10 years. And the best way to reduce time is to recruit patients quickly, which is increasingly difficult to achieve in Western countries.
Patients enrolling in clinical trials are not financially compensated for their participation but simply benefit from free treatment, including doctors' consultations, transportation, etc.
Considering that health expenses are almost entirely covered by the government in European countries, patients have little incentive to enroll in clinical trials. Similarly, in the United States, patients are more often than not covered by health insurance policies.
As a result it is those most vulnerable, with few resources of their own and living in countries with poor social security systems, who are likely to enroll more easily in drug trials.
What's worse is that patients are in most cases recruited by their doctor, who is responsible for arbitrating between his patient's well-being, scientific progress and, inevitably, his own financial benefits. Benefits, which are in most cases quite significant.
In Europe, for instance, a clinical trial which requires the doctor to see his patient approximately 10 times pays anywhere between 25,000 and 50,000 euros per patient, according to the drug's potential market.
These risks are not specific to the developing world. In fact, most clinical trials conducted in emerging economies are multi-locations studies, often conducted simultaneously in investigation centres in the US or in Europe.
As a matter of fact, 64.3% of clinical trials currently conducted worldwide have at least one investigation centre located in the US.
Clinical trials bring in new technology and new treatments and they also sensitise the bio-medical community towards the country's need to advance medical and clinical research.
However, when clinical trials are conducted in areas where patients are mostly uneducated and destitute, ensuring adherence to ethical clinical practices can prove difficult.
In fact, if most countries, including India, have issued national guidelines, instances of unethical and illegal trials have often been brought to the limelight.
The clinical trials on Danish multinational Novo Nordisk's new anti-diabetes drug, Ragaglitazar, suspended in India in July '04 after the discovery of urinary bladder tumour in mice, is one of them.
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