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Child Subjects Proposed for AD Treatment Trials

June 4, 2015 | Contact Author | By: Jennifer Novoseletsky
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According to a report by Dermatology Times, treatment options to treat atopic dermatitis (AD) are expanding, and dermatologists anticipate new therapies akin to recent breakthroughs for managing moderate-to-severe plaque psoriasis.

However, a recent meeting of the U.S. Food and Drug Administration (FDA)’s Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) highlighted an unmet medical need for systemic treatments approved specifically for children with severe AD. In relation, pediatric dermatologists cited the exclusion of children from the drug development process as a major concern.

“Prior to the meeting, we anticipated differing opinions about the importance of including children in clinical trials,” said Elaine C. Siegfried, M.D., Dermatology Times editorial advisor and professor of pediatrics and dermatology, Saint Louis University Health Sciences Center; and temporary DODAC member for the March 2015 meeting, in the report. “But at the end of the day, there was unanimous agreement that [the] benefits of including children outweighed the risks, and even young children should be considered eligible to participate in trials.”

The FDA has always served as a strong guardian of children’s safety, observed Siegfried. More recently, however, there has been a change in how to best carry out this responsibility.

“We have evolved from a view that we must protect children from research to a view that we must protect children through research,” noted Michelle Roth-Cline, M.D., Ph.D., pediatric ethicist in the FDA Office of Pediatric Therapeutics in a presentation at the DODAC meeting.

According to Siegfried, AD affects more children than adults. This, in part, led to the concern from pediatric dermatologists over the exclusion of children from new drug development research since new drugs could better control their disease.

“We have been struggling for generations to make the best treatment recommendations for children with severe AD,” she said. “Finally, we have hope for the chance to offer them better options in the foreseeable future.”

In the meantime, Siegfried expects an ongoing dialogue about the issues of pediatric AD drug development. In addition, companies involved in the research will approach plans for pediatric studies with increased interest and effort.