Clinical trials are now moving to countries all over the world: China, Kenya, India, Tanzania, Nigeria, and everywhere else!
From the economical standpoint, conducting a clinical trial in one of these developing countries is relatively cheaper than conducting them in developed countries in North America, Europe, or Australia.
But the more compelling reason to outsource clinical trials is to test drugs on a diaspora of people, people with different genetic make-up, as well as to test drugs for diseases such as malaria, HIV, meningitis etc, which are more common to these developing nations.
But outsourcing clinical trials is not as simple as packing up your bags, getting onto a plane, and jetting off to a foreign land.
Clinical trials outsourced to developing countries are watched by IRB’s and regulatory agencies with the same level of scrutiny (if not a higher level) as those conducted in developed countries. In fact, various reports say that it’s tougher conducting trials in developing countries because of the ethical and legal guidelines that have to be followed.
I believe that informed consent in outsourced clinical trials would be a difficult task because the researchers would have to factor in cultural characteristics while preparing informed consent forms and while talking to clinical trial subjects. It also would be a problem when dealing with an illiterate or uneducated population, in which case simple language and efficient translation wouldn't be of much use.
The Declaration of Helsinki renders protection to human subjects in research who are underprivileged. Thus, IRBs and regulatory agencies have to ensure that these subjects are not being mistreated. The IRB from each participating institution/company needs to approve the clinical trial protocol. So very often you're stuck waiting for IRB approval from a dozen different institutions! How does this make a clinical trial more ethical or even ethical, for that matter???
I understand the need for an ethical and protocol review by an IRB. But, why can't just one IRB do the job?
Just a suggestion, but maybe they could have one IRB on behalf of the participating institutions and one local IRB. It would make things easier, speed up the trial, and save a lot of money.
Ok, so outsourcing clinical trials isn't the easiest task in the world. But what happens after you get IRB approval? After you begin the trial?
I'm sure that many of these trials are successful and offer the people of these countries a chance to receive possible life-saving drugs. But are these trials conducted ethically? A 100% ethically? Having lived in both India and Africa I can't help but imagine a lot of money hungry officials looking out for a quick buck in exchange for speeding up the process locally. I somehow can't believe it's all smooth sailing after IRB approval.
What do you all think?
Interesting topic. I think even if a local IRB is in place, you would have to have oversight by the sponsor IRB to avoid payoffs and the "quick buck" that you refer to. Having a local IRB would help overcome some of the issues with cultural and literacy that you mention.
ReplyDeleteThe movie the "Constant Gardener" touches on a lot of these issues. The film accurately and tragically portrays what happens when clinical trials are conducted and adverse events are discovered and hidden.
I did recently watch the Constant Gardener and thought that everything that happened in the movie was appaling. The Constant Gardener highlights unethical corporate practices of pharmaceutical companies among the underprivileged people of Africa. It shows us how the Declaration of Helsinki, which outlines ethical guidelines dealing with research on human subjects, was treated with utter disregard while conducting clinical trials of the anti-tubercular drug Dypraxa.
ReplyDeleteMy father's company would import pharmaceuticals into Africa, infact they still do. He recently told me about an acquaintance of his whose company wanted to market a drug in West Africa. They didn't want the expense and the trouble of conducting the trial and so they just paid a firm somewhere in North Africa to rig the study, the results, and the reports. Isn't that scary? To imagine that the drugs we take might not have gone throught the appropriate testing!
For anyone who may think I'm anti-Africa, I have nothing against Africa or Africans. I lived there for 11 years,it's my first home, and I love it.