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Identify a use case to build a POC demonstrating secondary EMR data use in patient recruitment for clinical trials. Feedback from stakeholders supports the validity. Potential issues include data availability and mapping, criteria selection, and regulatory barriers. Resources needed from various institutions. Address regulatory challenges and clinician referral issues.
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Goal Identify a use case and create a collaborative group to build a POC that demonstrates the secondary use of EMR data for patient recruitment for clinical trials
Is the use case good? • Chimezie: yes • Rachel: yes • June: yes? • Aaron: yes • Vijay: yes • Jyotishman: yes • Ronen: yes • Tom: Qualified Yes • Transformation • George Allen/VA: Yes • Susie – share with Lilly development • Yes • Don: Product uses machine learning • Qualified yes • Dan: Good use case • Adrian: Good use case • Alan: Yes • Eric N: Yes • Joanne : Yes
Issues • Characteristics of patients may not be available in the EMR • Broadness of Inclusion/Exclusion Criteria • Make sure you incorporate the hard cases • Variables of interest • Some other aspect of EMR shipping to the patient • Clinical Database and a funder of clinical trial • Interfaces • Mapping into EMR system…. Need for mapping tools • Data required for regulatory agencies.. • Interactions with Machine Learnining Social Networks • Metrics of success • Inter-rater reliability? • Coverage, etc. • Feedback • Explanation, data collection
Data Issue • Vipul: Will try to get some data • Alan: choose criteria to reduce the type of anonymyzation required • Need to develop specific criteria and data requirements spreadsheet • K anonymyzation • Data should come from at least two sources if not more
Resources • George Allen – college student • Tom – Get back to me • Ronen Fox: Hopefully at least 1 • Jyotishman: Get back to me • Scott Marshall: 1 student possible • Joanne: Get back to me • Aaron: Get back • Michel: 2 students or more • Rachel: 1 day/week • Alan: Get back to me • Eric: U Cincinnati – Bruce Aronow’s students • Amit Sheth’s students • Chimezie: • Vipul: 1 day/week • Susie: ! Student • Dan: 1 day/week • Marcus: something more concrete • Adrian – Rule bases applications … need to define
Concrete Project Plan • Do it on the next Telcon
Regulatory Issues • June: Federally mandate barrier… Clinicians cannot refer patients for research studies • A researcher can find cohort and go to the clinician