Community Health System-based Research with JoAnne Levy

Community health system-based research continues to become an important focus area for pharmaceutical and medical device sponsors given the recent FDA guidance on diversity in clinical trials. 

Our guest for this episode is JoAnne Levy, Vice President at Mercy Research, a part of Mercyhealth. 

Mercy Research is one of the largest fully integrated, community health system-based research organizations in the United States with more than 40 acute care, managed, and specialty hospitals, convenient urgent care locations, imaging centers and pharmacies. In 2022, over 38,000 Mercy patients contributed to research learning.

JoAnne has served in the healthcare industry for almost 30 years. She leads Mercy Research, a not-for-profit organization managing clinical and real-world-evidence research activities across Mercy. JoAnne serves as current Chair and inaugural founder of Mercy Women in Leadership Council and as a member of Mercy’s Diversity, Equity, Inclusion and Belonging Advisory Board.

JoAnne received her undergraduate, law and master of business administration degrees — all

with honors — from Washington University in St. Louis. 

Please join me in welcoming JoAnne on the Clinical Trial Podcast. 

Sponsor:

This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I’m particularly excited about Veeva SiteVault. SiteVault gives research sites one place to work with sponsors – to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/.

This podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Learn more at slopeclinical.com

Selected Links From The Episode:

JoAnne Levy on LinkedIn and email (JoAnne.Levy@mercy.net) 

Covidien

Mercy 

Healthcare Compliance Association (HCCA) conference 

Healthcare Compliance Books

Introduction to Coverage Analysis with Kelly Willenberg

Office for Human Research Protections (OHRP) – Research Community Forums (RCFs)

Epic Electronic Health Record System

Clinical Conductor CTMS by Advarra 

WCG IRB

National Cancer Institute (NCI) centralized IRB

DocuSign for Healthcare

FDA
Commission on Cancer

Cancer Research of the Ozarks

Guardian Research Network

NCI Community Oncology Research Program (NCORP)

Cox Heath

Grail’s Galleri Test

Show Notes:

[4:52] JoAnne’s transition from labor and employment and environmental law to Vice President of Global Logistics for pharmaceutical and medical device at Covidien to Clinical Research at Mercy 

[8:55] Challenges with working in an international role while striving for a healthy work-life balance 

[11:07] Qualities that helped JoAnne transition into a supply chain role without having to convince her manager at that time

• Her ability to learn and absorb new information quickly
• Her reputation within the company
• Her working relationships across many functional areas

[12:13] How did JoAnne convince executive leadership at Covidien when she was confronted about her lack of experience in supply chain?

[15:48] How to learn quickly?

• Be curious
• Gather data to put together a bigger picture and Identify gaps 
• Ask good questions

[16:45] Actions on part of a leader that need to be learned

• When do you have enough information?
• Are you willing to make a decision? 
• Are you willing to act with less than perfect information? 
• Do you own your decisions?

[17:39] Being a fast learner you have to be willing to be uncomfortable

• Uncomfortable to go back to not knowing what you’re talking about
• To be the one who needs to ask the questions rather than being able to answer them, particularly when leading the organization
• Respect the people and recognize that others know more than you do but also to appreciate the value you’re contributing as the leader

[18:30] How to transition into a new role?

• Leverage conferences, seminars, and programs – being a lifelong learner
• Surrounding yourself with a team of experts to understand “what” and “why” certain activities/ tasks were performed 

[20:06] On being an effective leader

• Being able to gather data and look at the larger picture
• Being able to put a puzzle together and focus on problem solving
• Being persistent in the face of challenges 
• Being able to deal with ambiguity – make decisions without perfect information and owning those decisions
• Understanding the value of the team – individuals can do tremendous work, but a group of individuals doing tremendous work can have even more improved results

[22:56] Value of conference and seminars 

[27:14] Community health system based research and how it’s different from research done at other types of institutions, such as academic sites or large academic institutions

• Community health system has a  focus on establishing a like life long relationship with it’s patients and treating patients in their own communities
• Community health system offers a single, very deep, very broad electronic health record
• Patients may be unable to travel to an academic center outside their community, and be able to participate in a research study

[30:57] Structure of Mercy Research 

• 501(c)(3) not for profit organization with an independent board of directors that operates across the Mercy Health System
• Centralized research organization
  • Oncology
  • Non-oncology
  • Precision Medicine *New*
  • Business
  • Regulatory
  • Clinical (nurses coordinators assistants)
• Physicians and nurse therapist 
• Single ministry-wide Mercy IRB plus commercial IRB support 
• Structure enables Mercy Research to Centralize, Standardize, Optimize, and Innovate
• Standard Operating Procedure (SOPs) and policies across the entire ministry and research
• Technology – Clinical Trial Management System (CTMS) integrated with EPIC (EHR) and single document repository 

[38:02] Local versus centralized IRB (or both)

• All submissions go to Mercy IRB  
• Mercy IRB is the IRB of record for research determinations. investigator initiated trials, humanitarian use device, expanded access
• Industry sponsored submissions may cede into a commercial IRB or NCI central IRB, which serves as the IRB of record
• Need to ensure research activities are consistent with Catholic health directives 

[42:03] Acceptability of remote research support 

***Sponsor Message***

This podcast is brought to you by Veeva. Veeva connects patients, sites, and sponsors, on a single technology ecosystem to make clinical trials easier and faster. I’m particularly excited about Veeva SiteVault. SiteVault gives research sites one place to work with sponsors – to reduce the number of systems and logins used to run clinical trials. To learn more, visit https://sites.veeva.com/.

***Sponsor Message***
Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Slope is trusted by industry leaders in complex early-phase clinical trials from top 50 pharma and CROs to emerging biotechs, and a global site network including NCI cancer centers and AMCs. Learn more at slopeclinical.com

[46:097] JoAnne’s leadership team at Mercy Research 

• Executive Director with responsibility of clinical and business team 
• Regulatory and Quality Assurance 
• Marketing
• Executive Assistant
• Precision Medicine/ Real World Evidence/ Data Driven Research 

[49:04] Precision medicine portfolio and precision medicine research team 

[49:52] Centralized data support

• Centralized data review
• Data management
• Remote consenting
• Data monitoring

[50:56] Remote/ electronic consent (e-consent)

• E-regulatory system can help improve remote/ e-consent process, patient, and provider experience 
• Research focused e-consent tools can make a smoother experience for the patients 

[55:00] Sharing information and collaboration in clinical research 

[57:14] On managing research expenses such as technology expense

• Research is not why Mercy exists. Providing health care to patients is why Mercy exists 
• Research is a choice that community health systems make. Research is required at an academic medical center because of its affiliation with that academic institution
• Mercy has a commitment to supporting a research organization like Mercy Research, and that is a financial investment. Because Mercy Research is not profitable
• Focus is on adding efficiency, adding effectiveness,improving the experience, adding compliance, and gaining value

[1:01:03] Recouping investment in research beyond dollars

[1:03:58] Study selection process for investigator initiated studies and industry sponsored studies

• All study opportunities are captured and track
• Study start-up process with six (6) milestones which acts like a funnel and not all studies make it to the final milestone i.e. launching study enrollment 
• Weekly study selection meetings 

[1:06:32] Criteria in Study Selection Tool 

• Do we have the patient population to support this particular protocol? 
• Is the study financially viable?
• Where is the study in its life? 
• Do we have time to be successful?
• Do we have the resources to support the protocol requirements in a safe and compliant way? 
• What is the clinical value of the protocol? 
• What is the strategic value of the protocol?

[1:09:43] Meeting with representatives of sponsors and/or CROs to improve learning and also to have transparent communication 

[1:12:59] Passionate Principal Investigator (Passionate PI) 

• A PI at an academic center has a job is to do and publish research, maintain a certain level of engagement, and involvement in research activities. This is not the case, typically, at a community health organization
• At Mercy we have someone who is acting as the PI who is passionate about the research and the protocol in question

[1:15:55] Super Sites

[1:17:18] The success and learnings especially during COVID and recovering from COVID research

• Executive support
• Getting buy-in/ alignment on centralized, standardized, and optimized research 
• Balancing mission and margin
• Having realistic and attainable enrollment targets, then performing to them, or else no one benefits
• Passion of PI
• Clinical research resources are precious 
• Not losing sight of the “Why” – in service of the patients, in service of clinical care, and in service of improving medical knowledge

Audio correction: JoAnne’s last name, Levy, is pronounced as “Lee-vee”.