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Conducting Research Outside the Industrial World

Posted on January 15, 2009

There are ethical and methodological issues to consider when conducting research in different cultures, states Mauricio Tohen (bio).

 

The proper and ethical way of conducting research outside the industrial world. And I guess there's two challenges; one is the proper and the other one is the ethical.

Why don't we touch on the ethical first?

Number one, one should never do a study elsewhere just because you cannot do it in the U.S., because ethical boards won't allow you. That's an absolutely forbidden place, so I think that would be number one.

Second is that, again, culture is different, so some issues that might not represent a challenge in the U.S. might be a challenge in other countries, so you have to be respectful to cultural sensitivities.

Now, the question is, do results in developing countries, are the results in developing countries the same as in the industrial countries? And the answer is not always, and that's a key methodological issue.

Let me just give you an example of placebo response. Placebo response might not be the same in a developing country as it is in an industrial world, perhaps because in a developing country patients have less, and maybe they have higher desires to get better, because there's nothing else. On the other hand, they might have a lower placebo response, because they do not trust the medical care that they have received, so they have no expectations. The point is that one should not assume that the placebo response is going to be the same.

Safety is also certainly genetically predisposed, so it is possible that some patients from particular ethnic groups might not have the same adverse events of patients from other ethnic groups. So, that's why it's important to not generalize, not always assume that what you found in a particular ethnic group is going to be — can be generalized to a different ethnic group.

If you're interested in finding out if the placebo response is going to be different in developing countries you need to know, because in your next trial you might want to do two separate studies. You might want to do a study only with patients from industrial countries and another one from developing countries, and if their placebo response, or the efficacy and safety of the drug, is the same then you might put the, you may be able to pool the data.

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Excerpted from interview with researcher at the 2008 Leadership Training Institute in Bethesda, MD.

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