A Drug Developer's First Experience With Decentralized Trials

By Ed Miseta, Chief Editor, Clinical Leader
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When the FDA released new guidance for companies in May, it seemed every drug developer was scrambling to convert its clinical trials to a decentralized approach. Advicenne was no exception.

The France-based company has spent a decade developing treatments for rare kidney diseases. Its lead asset, ADV7103, received a positive opinion from the Committee for Medicinal Products (CHMP) recommending approval for the asset as a treatment for distal renal tubular acidosis (dRTA) in the European Union. Trials for the asset are underway in Europe, the U.S., and Canada.