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EU Pharma Wants Regulators’ Help To Simplify Digital Endpoints Landscape

 
• By Vibha Sharma

The European pharmaceutical industry federation, EFPIA, says its member companies are not looking for shortcuts to develop and validate digital biomarkers, but want help from regulators to create the right evidence.

Smart watch for healthcare technology with futuristic element
Digital Endpoints May Allow A More Authentic Assessment Of A Patient’s Experience In A Clinical Trial • Source: Shutterstock

Drug companies in the EU are keen to devise and validate digital endpoints, but they want regulators to simplify the current complex environment around the process, find pragmatic solutions and issue guidance that can help move the field forward and offer more clarity.

The present landscape for developing and validating digital endpoints represents a complicated mix of different regulatory and evidence generation requirements,...

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