India “Ramping Up” for Clinical Trials

Ethical issues in research in developing nations (which, when done on behalf of Western drug companies, is called “outsourcing”) is a hot topic right now. (We’ve blogged about it here, here and here.) I think one of the best ways for ethicists and members of ethics review boards to get a grip on this topic is actually to read some non-Western sources once in a while. This is 2009, after all, and the internet brings a wealth of non-Western views right to your computer screen. Here’s a good example:

From The Hindu Business Line:

The clinical trials market is booming. The number of clinical trials being conducted in India has doubled from 170 in 2006 to 350 at the end of 2008, according to the Central Drug Standard Control Organisation.

And going by the indications in the first six months of 2009, the number of registered clinical trials in the country is likely to touch a new high….

The article notes that ethics plays an important role in this ramping-up:

The drug regulator is also ramping up its system and infrastructure to bring more transparency and ethics into clinical trials.

Apart from making it compulsory for all Clinical Research Organisations to register themselves and the trials being undertaken on behalf of any pharmaceutical company, a system is also being set up to track the volunteers who participate in these trials.

The regulator is putting in place a finger printing technology for the volunteers, which will make sure that the same persons are not involved in two different trials at the same time….

Notice that last bit: is anyone in North America using such sophisticated technology? Is anyone ensuring participants aren’t enrolled in multiple trials (rather than just asking trial participants)?
p.s. just to be clear: I’m not cheering for the use of finger-printing technology…just pointing out that it’s interestingly.

~ by Nancy Walton on July 26, 2009.

One Response to “India “Ramping Up” for Clinical Trials”

  1. Dear Chris:

    This is a very interesting post on clinical trials in emerging countries. I think it is definately worth looking into some initiatives being developed by certain emerging countries regarding research participant protection. For example: the double ethics review system in Brazil (local and governmental), the ratio of regulatory inspectors per trial in Argentina, the AAHRPP accreditation of the Samsung Medical Center in South Korea and the National Health Group in Singapore. Granted that these countries do not have the same experience in research ethics as Canada, the US or Europe where the concept of peer-reviewed trials has been in place for at least 40 years. Nevertheless, I think there are models worth examining with respect to accountability in research as some models go beyond peer-review or self-regulation. Furthermore, I invite you and your readers to look into the AAHRPP proposed revised accreditation standards where AAHRPP is expanding its accreditation elements to include transnational research.

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