A recent study mapping the outsourcing of pharmaceutical pediatric research in developing countries has raised the concern of exploitation. The study performed by Duke investigators Globalization of Pediatric Research: Analysis of Clinical Trials Completed for Pediatric Exclusivity, raises the concern that many of these trials are testing drugs that are unlikely to be reasonably available to the countries from where the research subjects are recruited. The study documented that more than one-third of the trials enrolled patients from a developing country and of these trials, more than one-third enrolled patients investigating cardiovascular and allergy/immunology diseases (e.g., atopic dermatitis and juvenile rheumatoid arthritis). To be sure, more than one-half of the trials involved studies of antiretroviral and antimalarial drugs, which address important health care needs of the developing countries. But a basic safeguard for the protection of potentially vulnerable populations is to test drugs first in populations that are less vulnerable, which would apply to the aforementioned cardiovascular and allergy/immunology diseases. Even if one wants to assume that parents gave volunatary informed consent for the enrollment of their children in research (a questionable reality), one needs to question the conclusions of institutional review boards (IRBs) that gave approval to the performance of these studies. Similar concerns have been raised in Chris MacDonald’s post on the Research Ethics Blog.
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