Approach to Generating Evidence of Drug Safety and Efficacy David - - PowerPoint PPT Presentation

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Approach to Generating Evidence of Drug Safety and Efficacy David - - PowerPoint PPT Presentation

Aug 07, 2023 219 likes •429 views

EHR-fueled Trials: A New Approach to Generating Evidence of Drug Safety and Efficacy David D. Dore, PharmD, PhD Chief Research Officer Optum Analytics Life Sciences 1 Mission Be the gold-standard solution for Create a fully

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David D. Dore, PharmD, PhD Chief Research Officer Optum Analytics – Life Sciences

EHR-fueled Trials: A New Approach to Generating Evidence of Drug Safety and Efficacy

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Mission

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  • Be the gold-standard solution for

EHR-fueled trials

  • Transform our EHR platform into

a pliable research platform that enables the learning health care system

  • Create a fully scaled, end-to-end

solution for clinical trial design, patient identification trial execution and analytics

  • Employ industry-leading experts

and connecting sponsors, care delivery organizations, and research participants to move research closer to clinical practice

Extending our analytics for faster, cheaper, better, more relevant clinical research to drive patient engagement, improve outcomes, reduce costs, facilitate population health management and speed medical product development.

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https://healthpolicy.duke.edu/sites/default/files/atoms/files/rwe_white_paper_2017.09.06.pdf

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Why we do randomized trials

Hernan and Robins. Epidemiology • Volume 17, Number 4, July 2006

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Optum’s unique sourcing model enables most comprehensive clinical data

Longitudinal Comprehensive Dataset: 70M+ Lives

Medical groups

Integrated delivery networks

Staging Area

Hospitals

Multi-specialty practices

EMR1

Small group practices

EMR2

Physician

  • ffices

EMR 3

Rx platform Billing system Rx platform Billing system Rx platform Billing system Rx platform Billing system

EMR1 EMR2 EMR3

  • Demographics
  • Lab results
  • Provider notes

(NLP)

  • Procedures
  • Diagnosis
  • Medications
  • Outpatient visits
  • Vital signs
  • Hospitalizations
  • Observations

Data & Analytics for Life Sciences Analytics for Providers

Processing: Validation. Normalization, Standardization. Mapping.

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Optum EHR-fueled clinical trial solution

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Optum is building an end-to-end EHR-fueled clinical trial platform to be embedded within the model

  • f care delivery in order to reflect real-world practice and drive patient engagement.

EHR data-informed and science-driven fit-to-study design

  • Protocol development,

including statistical design elements

  • Patient recruitment
  • Implementation program

Optum-cultivated cadre of study sites (CDOs)

  • Optimized, data-informed

choice of site based on trial needs

  • Efficient start-up due to

previously-built infrastructure and clinician engagement

  • Patient identification,

recruitment and retention EHR data-driven

  • Platform-enabled data

collection, management and cleaning

  • Centralized monitoring

and QA processes Real-world data science

  • Data analysis
  • Analytics to drive in-trial

refinements

  • Reporting and research

translation

  • Medical communications

DESIGN SITE SELECTION & PATIENT RECRUITMENT DATA OPTIMIZATION DATA ANALYSIS, REPORTING & TRANSLATION $$ $$$$ $$$$ $$

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Extending on current infrastructure

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  • Separate data process at appropriate

stage (e.g., Stage Environment, CDR)

  • Compartmentalized, compliant

hardware

  • Separate team of researchers, data

scientists, engineers, and operations

  • Handled, with permission, on behalf of

Care Delivery Organization

  • Analyzed within Optum, CDO,

sponsor, and/or regulatory agencies (e.g., FDA)

  • Supplementary electronic data

capture

  • Tools and automation for centralized

data verification, edit checks

  • Command center intervention enabled

by data visualization

to drive innovative data and analytics

  • fferings

Optum analytics data factory

EHR-fueled trial “Re-mastered Data”

based on Optum provider client data

New build

Funded innovation

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Moving Research Closer to Practice

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Research Practice Translate Practice Research Translate Inform

Current Paradigm Optum pRCT Platform

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Where we’re going – subsequent development/launches

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Trial offerings

  • Launch single Phase IV trial across multiple CDO sites
  • Launch full Phase IV program (i.e., multiple studies, multiple sites)
  • Phase III pilot

Program scope

  • Protocol development, refinement, and targeting
  • Development of cadre of CDOs sites ready to deploy for study needs
  • Automation of data capture
  • Clinician engagement and training
  • Patient engagement
  • Integration of remote patient monitoring tools, telemedicine capabilities
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Value opportunities across trial lifecycle

Centralized data auditing …

Analysis and reporting

Replace primary data collection, data monitors, and

  • n-site quality

assurance Passive follow- up of patients Light-touch research Track participants lost to follow-up

Study conduct and data handling

Identification of specific patients and providers Recruitment on behalf of sponsor and CDO by Optum Group-level randomization Advanced analytics to choose efficient populations

Patient recruitment

Identification of specific patients and providers Enable providers to quantify the value of participating (e.g., # of patients, cost, financial risk) Coordination across CDOs

Site initiation

Quantification of patients at site Advanced analytics to identify best sites and patients (e.g., likely participants) Sponsor preferred sites can be on- boarded, driving growth of Optum One

Site selection

Data-driven design Eligibility criteria informed by data for greater efficiency Pre-trial analytics ensure that trial will target most appropriate population

Protocol development

Provide match- making service between sponsors CDOs Assess suitability of population Simulating trials before recruitment (enabled by data platform)

Opportunity identification

Value

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Current Workstreams

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NETWORK EXPANSION – onboarding preferred research sites NEW DATA PIPELINE – hardware, data engineering, compliance, security UPSTREAM DATA ACCESS – working with care-delivery organization as healthcare operations analysts DATA MEASUREMENT PROJECT(S) – comparing classical data collection to EHR-based

Real-world Data Real-world Information Real-world Evidence

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Current Workstreams

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NETWORK EXPANSION – onboarding preferred research sites NEW DATA PIPELINE – hardware, data engineering, compliance, security UPSTREAM DATA ACCESS – working with care-delivery organization as healthcare operations analysts DATA MEASUREMENT PROJECT(S) – comparing classical data collection to EHR-based

Real-world Data Real-world Information Real-world Evidence

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DURATION-3 Results (Selected)

HbA1c (%) Weight (Kg)

Diamant, et al. Lancet Diabetes

  • Endocrinol. 2014 Jun;2(6):464-73.
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DURATION-3 Results (Selected)

HbA1c (%) Weight (Kg)

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Summary

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  • Most healthcare entities base policy decisions on clinical trials

– Pros: Clinical trials are carefully done and give accurate answers – Cons: Answers may apply only to highly selected populations, ideal settings

  • Efficacy = Effectiveness?
  • For appropriate applications: With advances in data and research

methods, we can conduct OBSERVATIONAL real-world effectiveness studies to directly measure patient outcomes.

  • For many applications: We will need to conduct RANDOMIZED trials.

This journey is just starting. Please join us.

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Thank you.

david.dore@optum.com

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Confidential property of Optum. Do not distribute or reproduce without express permission from Optum.

Thank you

david.dore@optum.com