A new study investigates the benefits of extrapolating results from clinical trials involving adults to make conclusions about how the drugs will impact children.
As the study notes, pediatric drug development lags behind drug development for adults by about eight years, and it is considered desirable to limit unnecessary clinical trials involving children. One solution to this challenge, favored by regulators in both the European Union and the United States, is “pediatric extrapolation,” a strategy “based on assessing the relevance of existing information in the adult population to the pediatric population, in terms of the disease, drug pharmacology, and clinical response to treatment,” the study says.
According to the study, “Extrapolation as a Default Strategy in Pediatric Drug Development,” published in the Journal of Pediatric Infectious Diseases Society, the amount of extrapolation possible is different with each trial and each drug being tested: “The degree to which extrapolation can be used lies along a continuum representing the uncertainties to be addressed through generation of new pediatric evidence.”
In some cases, pediatric clinical trials may be completely avoided based on extrapolation from trials involving adults, and in other cases, information from the adult trials can be used to reduce the size and scope of pediatric trials, the study explains.
The study lays out suggestions and areas for further discussion when it comes to determining the appropriate amount of extrapolation, and concludes: “It is a clear ethical obligation to ensure that children are not enrolled in unnecessary clinical studies. This obligation compels us to explore the use of extrapolation, when scientifically and clinically appropriate, to the fullest extent possible when designing pediatric clinical development programs.”