A recent analysis by Duke researchers, including Dr. Sara Pasquali, Medicine ’02 and assistant professor at the Duke University Medical Center, examined the globalization of pediatric trials and its ethical and scientific implications. The report, titled “Globalization of Pediatric Research: Analysis of Clinical Trials Completed for Pediatric Exclusivity,” reviewed data from 174 trials conducted since the passing of the Pediatric Exclusivity Provision, which extends patents by six months for companies that conduct safety and efficacy studies with children. More than one-third of pediatric trials it considered enrolled patients from developing nations overseas. But with international testing comes the necessity of centralized review boards and training in research methods and ethics, according to the report. The Chronicle’s Lauren Carroll spoke with Pasquali about her research and the ethical implications of trials.
TC: Some articles written about your research have compared the youth from underdeveloped countries participating in the tests to ‘lab rats,’ though your report never uses the phrase. How accurate is this portrayal, and what role does the Pediatric Exclusivity Provision play in all of this?
SP: Well that’s not something we necessarily said in this paper. I think to fully understand this provision, you have to understand that there are some advantages and disadvantages, positive and negative things about the legislation. The positive would be that because of this law, [more than] 150 drugs have been studied on children that otherwise would not have been studied at all and we would have no information about their efficacy in children. The other positive thing is that this legislation has allowed us to have a better understanding of how drugs work in children worldwide and has allowed us to improve the health of children not just in the U.S., but throughout the world—which is very important. But then the other thing to think about in terms of the potential negatives would be that there are certain scientific and ethical implications that you have to consider when thinking about this.... This is a complicated issue to think about. This law was designed to encourage research that would enable the [Federal Drug Administration] to label drugs appropriately for children in the U.S. [with] regards to the dose and how safe they are. It’s not really known whether it’s valid to extrapolate the results from studies that are conducted in children overseas or another country, and there are a number of reasons for that. Some of it depends on their genetic background, some of it may depend on their access to health care resources and all of these things might differ in other countries.
TC: Is it important for researchers to disclose where their studies take place for the sake of clarity?
SP: So I think that one thing we discussed in our project that’s very important is yes, just to have a better idea of where these studies are conducted and what is going on because right now over half the studies are not even published in medical literature. Number two, when they are published, a significant number of them don’t have any information about where the studies took place. We’re requiring that the studies are published and that they contain information about where the testing took place so we’re able to study that in more depth, which would be very helpful.
TC: It seems that the reason pharmaceutical companies are conducting these tests overseas is because there is an economic incentive to do so. Why do the companies conduct the studies overseas, and what role does the provision play in this?
SP: Well, it doesn’t exactly provide incentive for companies to test in developing nations. It only provides an incentive for conducting studies on children, and how it does this is by providing a six-month patent extension to the pharmaceutical companies for conducting the studies. Now, the drug company may decide to conduct the study overseas in order to increase their ability to enroll a number of children in a timely manner. It’s also much cheaper to conduct studies overseas and outside the U.S. in many cases because there are fewer regulatory requirements, so those are the potential reasons.
TC: What additional measures would you support going forward with this sort of testing?
SP: [One] thing that might help would be requiring that the pharmaceutical companies describe how the places it’s studying are related to the intended market and the drugs being tested. For example, if you’re studying a drug in Africa or some sort of underserved country, are the drugs then going to be made available to the people that you’re studying once the trial is over?
Get The Chronicle straight to your inbox
Signup for our weekly newsletter. Cancel at any time.