Decentralized trials getting some attention on the international regulatory front

DIA Europe, by Regulatory Focus, 24 March, 2023

Work is progressing to overcome the obstacles associated with European decentralized clinical trials and advance their adoption, regulatory and industry officials said during a panel session at DIA Europe 2023. An upcoming guideline from the International Council on Harmonisation (ICH) may soon boost these efforts.

At the meeting, a panel of EMA officials, representatives of patient groups, and pharmaceutical industry representatives discussed some of the current challenges in conducting decentralized clinical trials in the EU, where differences among member states hinder its adoption among sponsors.

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This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 831458. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.

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