Trial, and many errors

The Times of India

Rema Nagarajan, TNN, Apr 23, 2011, 06.42am IST

About 14,000 girls, aged between 10 and 14 years in the Khammam district of Andhra Pradesh were vaccinated with the human papilloma virus (HPV) vaccine as part of a study on the efficacy of the vaccine against cervical cancer last year. These girls were mostly tribal children whose parents were agricultural labourers. The public outcry following the death of six of the girls led to the government suspending the study. It was later found that there were several violations of existing protocols. The parents of the girls, who were staying in hostels , were never informed. Instead , consent was taken from the wardens.

The government denies that the HPV vaccination was a clinical trial. Whether it was a trial or a study, there is no denying that the dramatic explosion in the number of clinical trials being conducted in India —from just about 100 in 2005 to over 1,000 in 2010 — is leading to concerns about the safety of those recruited for the trials.

In the 1990s, the global pharmaceutical industry, faced with rising pressure to reduce the cost and time taken by drugs to reach the market, started outsourcing several R&D-related efforts. This led to the growth of contract research organisations (CROs) that rapidly grew to become a $20-billion market by 2008, slated to touch $35 billion by 2015. CROs are said to complete clinical trials about 30 per cent faster than trials conducted inhouse by pharma companies. They now act as one-stopshops for all services, from preclinical trials to marketing.

Though India accounts for just over half a million dollars of the global CRO market, along with China and other countries in central and eastern Europe and Latin America , it is expected to become the future outsourcing destination of choice. As of today, the bulk of clinical trials, over 83 per cent, are located in developed countries. But the gradual shift to the developing world has sparked international concern over outsourcing of trials to countries without adequate regulatory mechanisms to protect the trial subjects.

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