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Precision Medicine- Optimizing Patient Selection Janet Woodcock- “ How can we apply modern tools?...
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Precision Medicine- Optimizing Patient Selection
Janet Woodcock- “ How can we apply modern tools? ”
Mark Rogge- “We need to understand the patients”
Participant-Centered Trials using Pervasive Computing Devices
to capture real-time data and reveal the actual features of disease
Ways to improve pre-enrollment, assessments, and post approval
Stephen H Friend MD PhD Sage Bionetworks
Center for Health Policy at BROOKINGS
Session III July 28, 2015
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Precision Medicine has up till nowprimarily focused on defining subgroups
It has not focused on realities of fluctuations
Hypothesis: Better tracking of patients at baseline and understanding the fluctuations in daily changes will allow more accurate measures of interventionsEspecially for changes in their quality of life
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Phenotypic Data
Asymmetry of Data driving Precision Medicine: The public can help with this
Genotypic Data
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Participant –Centered Research Studies with Feedback Loops
Anecdotes into Signals
Partners Partners
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iOS based mHealth Research Kit
Framework for Clinical StudiesConsents, Surveys, Tasks, Passive DataOpen Code hosted on GitHub for re-useApple does not see any of the dataSage Bionetworks- as a neutral repository
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Tanner Kruger BloemKieburtz
mPower
Trister
Dorsey
Klein
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Parkinson mPower Study App
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Parkinson mPower Study App
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Parkinson mPower Study App
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Parkinson mPower Study App
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Within first three months of mPower being available
15,439 consented individuals
11,360 enrolled
(largest Parkinson Disease trial ever assembled)
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62 y old Man 67 y old Woman
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Real loads and reliefs that exist – that modulate severity of symptoms against which the impact of medications should be assessed
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Need for better ways to follow Dementia
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Federated Approaches for Digital Phenotyping
Open Data
Open Source Code
Direct Comparisons
Diversity of Cohorts
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participant centered data from apps
benefits to understanding how to enrollfrom early trials through post-approval
benefits to the individual
( Movement Disorders, Rheumatoid Arthritis, Anemia, Melanoma, Cognition, Mood)
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Opportunities for Pervasive Computing to impact Clinical Trials:
A. Pre-Enrollment baselines for patients before they enter trials
B. New secondary end-points and ways to distinquish from existing therapies
C. Post- Approval Surveillance