The Role of Digital Health Technologies in Drug Development Proceedings of a Workshop (2020) / Chapter Skim
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7 Reflections and Key Takeaways
7 Reflections and Key Takeaways
Pages 87-92
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From page 87... ...
Jennifer Goldsack and Joseph Menetski discussed the risks associated with the use of new modalities for collecting digital health data, the importance of patient centricity and education, the need for standards and frameworks for evaluation, and other barriers and opportunities. CHALLENGES ASSOCIATED WITH THE USE OF DIGITAL HEALTH TECHNOLOGIES With the new methods enabled by DHTs come novel data, but also concomitant new risks, Goldsack said.
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From page 88... ...
She reiterated a call to action that was issued by Amy Abernethy and then echoed through the rest of the workshop's discussions: the need to bridge the divide between data generated through clinical care and clinical research. Digital measures of real-life phenomena warrant commensurately practical strategies for collecting that evidence in the real world, in ways that are perhaps less controlled than traditional methods.
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From page 89... ...
Although DHTs provide opportunities to expand and standardize the capture of data in clinical research, Menetski said that strategies will be needed to work within the current existing limitations of data quality BOX 7-1 Standards Needed for Evaluating Digital Health Technologies • Verification • Analytical validation • Clinical validation • Defining, describing, and understanding the data collected by these technologies • Shared methodological approaches • Data capture and interoperability SOURCE: As presented by Jennifer Goldsack and Joseph Menetski, March 24, 2020.
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From page 90... ...
For instance, the pharmaceutical industry has instituted several initiatives for driving standards and using devices and data in noncompetitive ways, such as the Metrics Champion Consortium1 and TransCelerate.2 She suggested several other initiatives that might be useful resources, including the Digital Medicine Society,3 the Clinical Trials Transformation Initiative, and the Open Wearables Initiative. "PAIN POINTS" ACROSS THE DRUG DEVELOPMENT PROCESS AND SOLUTIONS DIGITAL HEALTH TECHNOLOGIES CAN PROVIDE Menetski reflected on the differing "pain points" across the drug development lifecycle that speakers presented, and he summarized the opportunities that DHTs provide as well as the unique challenges that arise when they are used in clinical research.
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From page 91... ...
. Speakers discussed a concrete solution to this barrier; rather than waiting passively for a single entity to take the initiative, the entire community should take collaborative action to develop gold standards.
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