The FDA wants pharmaceutical and medical device manufacturers to enroll diverse patients in clinical trials.
One way to achieve the diversity goal is to engage with physicians in the community and provide them with the resources and support to conduct clinical trials.
To learn about community engagement in clinical trials, what it means, recent regulations and guidance documents, I invited Chris Komelasky, CEO and Co-founder of SiteBridge Research, on the podcast.
SiteBridge Research is an Integrated Research Organization (IRO). Chris and his team help connect physicians and their patients to clinical trials and facilitate the process by reducing barriers for sites and participants.
Prior to the launch of SiteBridge, Chris has held various leadership roles at PPD, GlaxoSmithKline, Accenture and ZS Associates.
Chris holds a B.S. in Systems Engineering from the University of Virginia and an MBA from Duke University and resides with his wife and three children in Chapel Hill, NC.
Please join me in welcoming Chris on the Clinical Trial Podcast.
Sponsor(s):
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. 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 https://www.slopeclinical.com/
Referenced Works:
Chris Komelasky LinkedIn Profile
American Society of Clinical Research Professionals (ACRP)
Society of Clinical Research Sites (SCRS)
Electronic Medical Records (EMR)
National Institute of Health (NIH)
CRAACO: Clinical Research as a Care Option
Drug Information Association (DIA)
American Medical Association (AMA)
Books:
Health Apartheid – Harriet Washington (Amazon, Barnes & Noble)
People Mentioned:
Show Notes:
[0:20] Chris Komelasky Background
- CEO and Cofounder of Site Bridge – integrated research organization
- Former Executive Director of PPDs
- Lead PPDs global investigator services and strategic site collaboration team
- Launched PPDs rare disease and pediatric center of excellence
- Worked at Glaxo Smith Kline leading commercial efforts
- BS in Systems Engineering from University of Virginia
- MBA from Duke University
[2:40] Sponsor Message: Veeva Site Vault (https://sites.veeva.com/)
[4:16] Defining Community Engagement in Clinical Trials
- Building, maintaining and sustaining relationships in the community not necessarily tied to patient recruitment
- Encompasses aspects of patient life outside of the clinic: organizations, groups, businesses, and activities that bring patients together
- Actively connecting those groups with leaders and helping to build trust and awareness
[6:36] Role of Site Bridge
- Partner with clinical trial sites in the local community and help them set up clinical trials
- Trying to create access points for patient communities outside of academic medical centers and big health systems
[7:42] How does Site Bridge go about doing this?
- Balancing what needs to be done with the sequence of how to go about doing them
- Find practices that have interest and capacity to access more diverse patients
- Build that relationship
- Understand physician needs – find studies that are a good fit for physicians and patients
- Sometimes challenged with clinicians that are not experienced with research
- Training sites is a huge part of the effort
- Partner with ACRP as a GCP training partner
[12:34] ACRP Training
- Has modules to train investigators
- Modules are interactive and distill key research aspects
- Foundational for sites understanding of how to do research
[13:43] Presenting Sites to Sponsors
- Set up a track for site to get research ready
- Use Cypress team members to quarterback the practice and integrate with their workflow
- In parallel looking at EMR system to see patient characteristics
- Start with diagnostic type studies as an easier first trial for site to hone its operational strategy
- No one size fits all approach to getting sites ready
[17:49] How does Site Bridge identify sites?
- “Trial In A Box” – used to assess site infrastructure, workflow, and research capacity
- Try to move site to digital for quality and remote access functionality
- Try to get sites a Clinical Trial Management System and an eRegulatory component, eSource, and eClinical workflow
[22:35] Electronic Tools for Clinical Trials
- CRIO for Clinical Trial Management System and eSource
- Florence Healthcare as an eRegulatory System
- BEK Health for EMR matching
- Systems allow for AI extraction of clinical information in EMR in a way that is HIPAA compliant
[26:06] Identifying Community Engagement Sources
- Sometimes simply trial and error
- Can take many forums from faith based leaders, to local business
- Looking for whoever is consistently connecting with the community
- Many patients are research naive and sites need to be trained how to inform them about it
[29:44] Lesson Learned from First Site Launch
- First site was a free and charitable clinic
- Working with vulnerable population means a good deal of effort was spent ensuring their intentions and expectations were fair to clinic
- Trying to not only represent the intentions of their organization but also the spirit of the site
- For physicians time is their most precious commodity and that always needs consideration
- Core anchor in physician patient relationship
- Sometimes low tech, boots on the ground, face to face is the best approach
[38:37] Diversity and Inclusion in Clinical Trials
- Diversity hasn’t always been a primary interest for studies but has changed recently
- COVID was a partial driver for this change
- April 2022 FDA put out guidance around enrolling more minority ethnic groups in trials
- Sometimes studies benefit from having a trial diversity plan
[42:45] Sponsor Message: Veeva Site Vault (https://sites.veeva.com/) & Slope Clinical (https://www.slopeclinical.com/)
[45:02] Where does the bill fit into clinical trial diversity requirements?
- Public forum where laws, mandates, and guidances intersect can be a bit murky
- Depict Act had most content on specifically enrolling minority patient groups
- Bill essentially summarizes the mandates one level higher, but is not 1 to 1
- Bill comes after Act
- Now we wait to see what the FDA is doing in this space as diversity plans have been brought forward
[52:31] Decentralized Trials and Community Engagement
- Decentralized trials is standard terminology
- 80-90% core research fits into this design
- Still a site plus investigator model
- Adds flexibility to make sure data is captured in a quality manner with correct oversight
- Presents new community entry points for research like pharmacies such asCVS and Walgreens
[56:28] Differences between CVS Health and Walgreens approach
- CVS Health first mover – trying to take Minute Clinic Model and be thoughtful about their community footprint
- Walgreens – started late and are using a more conservative approach with study areas
- Individual experiences influence perception of community touch points
- Trust is integral to experience and erosion of trust requires much effort to fix
[1:03:40] Transportation services for patients
- No direct collaboration with transportation services like Uber or Lyft
- Still push for transportation to be included in the budget as it is important for supporting patients
[1:04:51] Study Budgeting
- Try to use fair market lens for everything from physician compensation to patient reimbursement
- Advocating for patients is important and that’s where things like transportation,child care, meals, housing, time, etc. get factored into the budget
- Comes down to rationalization and justification
- Be thoughtful of time commitments placed on patients for studies
- Consider non-patient items such as interpreter’s services, translation services, etc.
[1:09:35] Resource recommendations and closing thoughts
- Leverage existing educational awareness resources from organizations such as NIH, CRAACO, SCRS
- Learn from other areas of human experience
[1:18:47] Sponsor Message: Slope Clinical (https://www.slopeclinical.com/)
