2020
DOI: 10.1159/000512500
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Abstract: Innovative tools are urgently needed to accelerate the evaluation and subsequent approval of novel treatments that may slow, halt, or reverse the relentless progression of Parkinson disease (PD). Therapies that intervene early in the disease continuum are a priority for the many candidates in the drug development pipeline. There is a paucity of sensitive and objective, yet clinically interpretable, measures that can capture meaningful aspects of the disease. This poses a major challenge for the development of … Show more

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Cited by 46 publications
(70 citation statements)
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“…Indeed, the skills required for successful measure selection, development, and deployment rarely reside in one organization, necessitating a collaborative approach [3, 8, 24, 30, 85, 89]. Recent progress in digital measures for Parkinson disease highlights this point [84]. If we work together, digital health measurement can become a mainstay of clinical development, maximally benefiting patients and speeding and reducing the costs of developing therapies.…”
Section: Discussionmentioning
confidence: 99%
See 1 more Smart Citation
“…Indeed, the skills required for successful measure selection, development, and deployment rarely reside in one organization, necessitating a collaborative approach [3, 8, 24, 30, 85, 89]. Recent progress in digital measures for Parkinson disease highlights this point [84]. If we work together, digital health measurement can become a mainstay of clinical development, maximally benefiting patients and speeding and reducing the costs of developing therapies.…”
Section: Discussionmentioning
confidence: 99%
“…Taken from the perspective of clinical development, digital measures can be seen as tools to enable product development and other assets rather than as assets themselves. The view of digital measures as precompetitive tools is increasingly accepted and advocated for [37, 74, 84, 85].…”
Section: The Importance Of Collaborationmentioning
confidence: 99%
“…A clear advantage is that telemonitoring, by virtue of the objective and longitudinal assessment in the patient's own home environment, may offer a very sensitive indication of therapeutic benefits. An important challenge is how to interpret such telemonitoring outcomes in terms of their clinical meaningfulness, even when statistically significant [ 39 ]. The increasing adoption of telemonitoring in clinical trials, alongside existing measures for patient functioning and quality of life, will help to further refine the reliability and validity of telemonitoring outcomes and support its acceptance by regulatory bodies.…”
Section: Telemonitoringmentioning
confidence: 99%
“…Headway towards the qualification of digital measures for real-world gait speed as outcomes in a range of conditions was presented by the Innovative Medicines Initiative-funded Mobilise-D project [3]. The Critical Path for Parkinson’s Consortium presented updates towards their vision for a precompetitive, multistakeholder, regulatory framework to enable the development and acceptance of digital measures and other digital tools for Parkinson’s disease [4]. The work of Beattie et al [5] shared details on a new data platform for passive data collection in the homes of diverse cohorts of older adults.…”
Section: Special Issuementioning
confidence: 99%
“…Stephenson spoke about the importance of incorporating patient centricity in clinical development and the notion of whether digital measures are a precompetitive tool or a competitive advantage. Much of the work in the special issue was done by, or was directly supported by, precompetitive consortia supporting the value of these projects [3, 4]. By incorporating person-generated health data into core business operations, we can understand daily patient burden as a function to force the development of better interventions [16].…”
Section: The Expert Panelmentioning
confidence: 99%