Sunday, March 01, 2009

The ethics of outsourcing clinical trials, one more time

Since the mid-1990's, and clinical trials on drugs to prevent mother-to-child transmission of HIV in Africa, there has been a growing academic literature on the ethics of clinical research in developing countries. Of course, this is an academic literature, which means that only a vanishingly small number of the world's population has actually read any of it. But the general popularization of the economic practice of 'outscorcing' has raised public awareness of the debate somewhat, together with the steady stream of scandals and suspicions emerging out of India, which seems to be a lightning rod of ethical concern about clinical trials lately. The global clinical trial outsourcing phenomenon is a wild and woolly affair: it is not known precisely how much of it is going on, precisely what sorts of studies are taking place, how regulatory oversight works (or doesn't) in actual practice, and what to think -- from an ethical point of view -- about the whole messy business. And it is important to get some clarity on this subject: given the vast health and other inequalities between the agencies funding and institutions largely conducting clinical trials in developing countries, how can such studies avoid plunging into one or another ethical pitfall? So it is timely that the New England Journal of Medicine published a commentary entitled 'Ethical and scientific implications of the globalization of clinical research' a couple weeks ago.

However, a piece in the New York Times on the NEJM commentary was not very positive, and it is not hard to see why. The authors breezily trot out the usual ethical problems in clinical trials: relative lack of understanding of research procedures by research participants; possible undue inducement by financial compensation offered to the poor; large differences in standards of care and possibility of ethical double standards, i.e. study designs in developing countries that would be allowed in more affluent ones; uneven research oversight by local ethics committees; drugs tested on participants not being responsive to local health needs; drugs developed from the research not being accessible to the communities who participated in the research. All of these are legitimate concerns, or at least can be, in particular clinical trials. But the NEJM article does not add anything here to current debates engaging with more fundamental questions: how much understanding is 'enough' for informed consent, in any research study, with any population? What makes an inducement undue? Are all cases of double standards wrong? What does it mean for a study to be 'responsive' (or not)? Are all cases of communities not having (immediate?) access to study drugs necessarily ethically wrong?

Whenever the commentary departs from old concerns, it seems to glide into hot water, particularly when it offers recommendations to address the ethical problems raised by the globalization of research. The authors suggest that clinical trials are outsourced largely because of bureaucratic regulations in developed countries, which adds to research costs, and therefore these regulations should be 'streamlined' in order to de-incentivize doing clinical trials abroad. It is a charming idea that ethics committees would be responsible for stimulating the globalization of research (and indirectly, the ethical problems that go with it), but it seems more likely that streamlining the processes at home will simply increase the number of trials abroad, as long as the economic disparities between countries remain in place. You will simply get your IRB approval faster. Besides, if you want to 'de-incentivize' clinical trials abroad, why not build up ethical review in developing countries, or force pharmaceutical companies to pay to build local health infrastructure and capacity as a cost of doing business, rather than scaling down IRB processes at home?

There is a sneaking sense in the NEJM commentary that the ethical problems raised by the globalization of clinical research is 'our' problem -- i.e. that of the more affluent countries -- and that it our responsibility to fix it:

Industry sponsors, contract research organizations, and the academic community can meet the challenges of globalization by accepting full responsibility for the ethical conduct and quality oversight of these trials.

There is little hint that such responsibility needs to be -- for ethical and practical reasons -- shared with local communities in which research takes place, as well as national governments, ethics committees, research institutions, NGOs, and other stakeholders. Developing world researchers enter the picture indirectly, and mostly passively, as the recipients of training in conduct of clinical trials. True, there is talk of 'reaching international consensus' on the ethics of global clinical research, perhaps in conferences held by the WHO or Institute of Medicine, and folks from the developing world could come too. But in the end, with this sort of top-down (and North-South) approach, the chances that the recommendations will be taken up, put much of a dent in the ethical issues surrounding outsourcing of clinical research, seems pretty dim. And the fact that this commentary about ethics and the globalization of research seems to have been penned exclusively by US researchers is not necessarily damning, but also not very encouraging either.


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Blogger George said...

Outsourcing health functions raises a couple of ethical issues. I agree that the NEJM commentary still failed in calibrating its observations like stating what should be 'enough' for informed consent etc.

Aside from the clinical experimentation in 3rd world countries, another interesting trend is the attempt to transfer certain functions for pharmaceutical production. Through
NIR technology, companies are able to validate the qualities of their output. Surely, NIR has been found useful in various industries because of its ability to effectively measure even minute details.

Interesting response to pressing health issues. Thanks!

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