Outsourcing Clinical Trials (Criticized)
(For more about what outsourcing is, see my entry on this topic over at the Business Ethics Blog, here.)
For a good overview of the worries, see this commentary by researchers at Duke University, in the New England Journal of Medicine. Here’s the full text of the paper: Ethical and Scientific Implications of the Globalization of Clinical Research (PDF). (You can also get a summary of the study in this NY Times story: Outsourcing of Drug Trials Is Faulted.)
Most of the NEJM paper focuses (rightly, I think) on questions about how tightly the relevant (local and international) standards are applied when clinical trials are conducted in developing nations — though as one expert (Zeke Emanuel) cited by the NY Times suggests, the NEJM article doesn’t provide evidence that outsourced trials are being done badly…it just suggests that we have too little evidence that they’re being done well.
The NEJM paper’s weak point, I think, is in the area of justice. The authors assert:
Developing countries will also not realize the benefits of trials if the drugs being evaluated do not become readily available there once they have been approved.
The authors suggest this conflicts with the values embodied in a key international document:
The Declaration of Helsinki expresses an expectation that every patient enrolled in a clinical trial should, at the end of the trial, be assured access to the best proven therapy identified in the study.
That argument conflates 2 different issues. One is the question of whether participants in clinical trials will keep getting appropriate care after the trial ends (and that’s what Helsinki talks about). The other is whether citizens, generally, in the country where the trial takes place, will be able to get access to the drug that (hopefully) results. The question of what is owed to research participants is entirely different, and should be answered in entirely different ways, than the question of what people in wealthy countries owe to people in poorer countries.