Drugs

Stakeholders Comment on Digital Data Acquisition Draft

Several drug and medical device industry stakeholders have submitted comments on an FDA draft guidance on digital health technologies for remote data acquisition in clinical investigations. Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports the agency’s ongoing efforts to facilitate the use of digital health technologies in clinical investigations for the evaluation of medical products.

PhRMA’s general comments cover the guidance scope, regulatory submissions and considerations, verification and validation of digital health technologies, usability studies, safety monitoring, novel endpoint justification, statistical analysis, the bring-your-own-device option, digital health technology interchangeability, and global harmonization. It also submitted line-by-line specific comments.

The Roche/Genentech comment letter gives general comments on regulatory submissions, leveraging prior data, regulatory engagement, and clinical relevance of digital health technology-derived measures. It also provides line-by-line specific comments.

AdvaMed says it supports the agency’s efforts to provide guidance on how digital health technologies may be appropriately used to collect data remotely in clinical investigations. “We believe that use of digital health technologies may facilitate the recruitment, enrollment, and participation of racially, ethnically, and gender diverse human subjects in clinical trials by reducing the burden of participation in clinical trials,” the association says. The letter includes recommendations to provide additional clarity and examples across the broad range of digital health technologies.

Bayer says the use of digital health technologies in clinical trials is “part of a modern innovative drug development paradigm that enables remote data collection and advances a digital future.” Its letter discusses general comments, the scope of the guidance, digital health technology description in a submission, bring-your-own-device, verification and validation of digital health technologies, statistical analysis, and good clinical practices.

BIO says that while the draft generally provides greater clarity around FDA’s approach to regulating remote data acquisition, there are areas that would benefit from more exploration, examples, and references. It provides comments on the benefits of digital health technologies, engagement across FDA, submissions, global harmonization, leveraging prior data, digital health technology usability, device specifications, data management, and future guidance considerations.

Line-by-line comments were submitted by GlaxoSmithKline and Bristol-Myers Squibb.

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