Description

The Food and Drug Administration has indicated diversity and representation requirements will be a focus of future regulations around clinical trials – and a key means of bridging gaps in representation for underserved populations. However, knowing what evidence is required to develop digital health technologies (DHTs) in the absence of established standards remains a moving target. This presentation will cover five questions for life sciences firms to consider when evaluating the use of DHTs in clinical trials. The proposed questions can have an impact on the level of evidence generated to support the development of new treatments, as well as diversity and representation requirements.

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