Research Future State Vision by Vani Nilakantan, PhD

Vani

Research provides opportunity

Research is the Cure

● to find a cure

● to help patients live better

● to improve lives

● to provide access regardless of age, socioeconomic status, race or gender

Industry Trends

Vision and Purpose CSHRI

Vision: To be a nationally recognized leader in innovative clinical research that transforms healthcare for the communities we serve.

Purpose: to provide research infrastructure support and serve as resource for CommonSpirit Health and aligned partners

Source: Guardian Research Network

CSHRI National Presence

Core Values

Major Accomplishments

●Integrity

●Diversity and Equity

●Accountability

●Respect

●Compassion

●Collaboration

Key Accountabilities

●CommonSpirit Health Research Institute Board of Directors

●Research compliance and operational standards

●Organized and aligned research programs across system

●Sole owner, non-profit subsidiary

●Single IRB

●Single CTMS

●One contracting party

●Academic Partnerships

●DE&I (MICA)

CommonSpirit Health Research Institute

Freenome Trial 7 sites, >6K patients, 6M revenue potential

Focus Areas

● Cancer- NCORP (NCI funded) ● Cardiovascular Research ● Neuroscience

Emerging Areas- Population health, Implementation Science, Women and Infants

53 locations

262 Investigators

282 studies

$6.8M

Resource for NCI trials ● Access for cancer patients

● Centralized Regulatory ● Centralized QA

Research Clinical Trial Partners

CSHRI provides the pathway to partner with industry and federal organizations

CSHRI Centers of Excellence

Sponsored Programs

Integrity and Compliance

RACE Research Analytics Center of Excellence

Research

Finance Research Operations

IRB

● Federal Wide Assurance

● IRB (internal and External)

● PRivacy Board Reviews

● IIR, GME and Student Research

QA

Samples of Shared Services

● COI reviews

● Post Approval Monitoring

● NCORP monitoring

● CAPA

● Regulatory Affairs Training and Education

● Staff Training & Onboarding

● CITI

● Education

● Policies and Procedures

Contracts

● Master CTAs/Agreements

● Single site CTAs/Agreements

● Just In Time Contracts

● Comprehensive Contracting Services (DUA, BAA, CDA etc)

Grants

● Research Grants

● Federal Grants

● Foundation Partnership

● Policies and Procedures

NCORP

● Program Management

● Centralized Regulatory

● Centralized contracting

● Infrastructure

● Financial clinical trial compliance oversight, which is a focus of the OIG

● Research clinical trial Budget Management & Negotiation

● Medicare Coverage Analysis (MCA)

● Clinical trial Research Revenue Cycle Management

● Clinical trial Financial Reporting

● Operational Finance

● Signal Path Finance

Research Site Operations

● Research Managers

● Research Coordinators

● Compliance to SOPs

● PI and Patient Facing

● Trial Path Implementation

New Business Development

● Preliminary Clinical Trial Feasibility

● Recruitment of PIs

● Study Implementation with New Site Onboarding

Data Support tools

● CTMS

● REDCap

● PI Tools analytics

● Statistical tools

● Clinical trial operation insights

Data Lakes for Research

● Data extraction

● ETL & Governance

● Registry integration

AI and Machine learning

● Automation of data extraction

● NLP and ML studies

● Clinical data mapping

GME Program Support

Priorities and Future State

Taking Care of Our People

Practice

Environment of the Future

Culture and PurposeDriven Leadership

Job Accountability & Standard

Staff Training & Education

Vision and Strategy, communication

Our Future

Quality and Clinical Enterprise

Operational Excellence

Academic Partnerships

Health Equity

More In Common Alliance - Research

One CommonSpirit

Org Alignment, Systemness, standardized process, system wide tools

(CTMS, IRB, SAS)

Financial Stewardship

Grants, Contracts, Philanthropy

Cost Savings

Convener and Thought Leader in Catholic Healthcare

Best in class national community research enterprise

ConsumerFocused Patient engagement

Decentralized at home trials.

DEI

Integrated Delivery Network

Growth and Diversification

Org Alignment

IIR/CT growth

Value-Based Care and Risk

National and local focus on strategy for research?? C o m m o n S p i r i t 2 0 2 6 Our People Our Excellence

Priority: People

● Staff Recruitment and Retention

● Education and Training

● Organizational Alignment

● Functional Reorganization - position alignment

● Diversity, Equity and Inclusion

● Address burnout and wellbeing

Priority: Excellence/Future Academic Collaborations

CSHRI

MICA-Research Workstream

Morehouse School of Medicine and CommonSpirit Health

Changing the Landscape of Health Care Research

● Driving health system change based on who we include

● 1-2 research projects each year

● Focus areas include cardiovascular, cancer, neuroscience, women and infants, population health

Principles

● Patient Centered

● Help improve diversity, equity and inclusion in clinical research (distributive justice)

● Enhance joint clinical trials and investigator initiated research

● Secure grant funding

● Lead innovation together

Health Research Institute

Priority: Future - Data Assets

● Research Data Scientist Recruitment

● Grant Specialist recruitment

● Data Infrastructure Alignment (EDP) ●

Internal data capabilities

● REDCap and CTMS

● Research Analytics and Data Council

● Governance and provisioning

● External collaborations (academic and vendors)

Priority: Data Infrastructure/Resources

Patient Intelligence Tool

Patient Intelligence

Patient Intelligence is a valuable tool that saves lives and expands access to critical care by enabling physicians to connect high-risk patients to cutting edge medical interventions and clinical trials

● 40 M unique lives

● 44 M distinct encounters

● 211 M diagnosis

● 24K patients with genetic data

● 3 Molecular Lab Caris, Neogenomics and Tempus Elements of Patient Intelligence

Searchable Patient Repository to create Patient Cohort for Research, Study, Quality Improvement

Hydrate Data Lake with Molecular data from Tempus, Caris and Neogenomics

Queryable doctors notes on terms

Patient Intelligence uses data from Research Data Hub, enabling population analysis (de-identified patient cohort analyses), identification of candidates for new drugs and building pursuit lists for care coordinators

EHR Matching with Molecular data

Priority: Visibility and Reputation

● Operational Excellence- best in industry

● Academic Partnerships

● National Recognition (scholarship,grants)

● DE&I

● Annual Report

● Research Summit

CommonSpirit Health Research Institute

Priorities

Academic Partnerships

External Industry Partnerships

Organizational Alignment

Operational Excellence

Growth and Value

●Clinical Institute support

Leading edge device and drug therapies

Precision Medicine

CSL and PE partnership

Scientific Support

Student/IIR

Diversity, Equity and Inclusion

● One CommonSpirit

●PE support

Value, Growth Research

Prioritization

Revenue, IP

CSHRI

Priorities

●Standardization of Process

●Data infrastructure, resources

●People

Visibility and Reputation

Recruitment Retention

Training/Education

Digital Strategies

Research Informatics and Analytics

Patient Experience

●Academic Partnerships

●Revenue Generation

●Investigator Initiated Research

Diversity, Equity, and Inclusion

●Website

●Annual Report

●Research Summit

●National Partnerships

●Scholarship and Grants

●Diversity in Clinical Trials

●Patient Engagement

●Employee Experience

●Student Research

●Philanthropy (REEF)

Contact Information

● Vani Nilakantan, PhD System VP Research, CSHR) , vani.nilakantan@commonspirit.org

● Mary Rydman, System Director, Research Operations, CSHRI; mary.rydman@commonspirit.org

● Julia Link, System Director, Sponsored Programs Office, CSHRI julia.link@commonspirit.org

● Vino Raj, MD, Clinical Research Informatics Scientist, CSHRI, vino.raj@commonspirit.org

● Melissa Aigner, System Director, Research Finance, melissa.aigner@commonspirit.org

● Russell Stolp, System Manager, Research Integrity-IRB, russell.stolp@commonspirit.org

● Lauren Bacon, System Manager, Research Integrity-Quality Assurance, lauren.bacon@commonspirit.org

● Bradford Williams, Program Coordinator, CSHRI, bradford.williams@commonspirit.org

https://sites.google.com/commonspirit.org/clinicalinstitutes/clinical-institutes-home/research