Promoting research partnerships to improve veterans’ health

NAVREF Industry Partner Consortium Meeting

March 21, 2023 

San Diego, CA

Attendees: 

 

               Kimberly Binaso (Genentech)

               Peggy Bradley (Biomedical Research Institute of Southern Arizona)

               Krissa Caroff (VA Partnered Research Program)

               Sean Cunningham (Janssen)

               Drew Darker (Janssen)

Theresa Devins (Cognition Therapeutics)

Allyson Gage (Cohen Veterans Bioscience)

               Kevin Havens (Exact Sciences)

               Calvert Lee (Palo Alto Veterans Institute for Research)

               Bill Leone (Avallano)

               Patricia Mader (Genentech)

               Waqar Malik (Wisconsin Corporation for Biomedical Research)

               Rebecca Rosales (Northern California Institute for Research and Education)

               Angie Smith (Northern Florida Foundation for Research and Education)

               Elaine Staats (Palo Alto Veterans Institute for Research)

               Hawk Tran (NAVREF)

               Katrina Washburn (South Florida Veterans Affairs Foundation for Research and Education)

               Phil Wellington (Seimans)

               Priscilla West (NAVREF)

               Rochelle Williams-Belizaire (Mirati)

              

Review of December 2022 IPC Minutes

For the next set of minutes, members would like to add a list of meeting attendees, as well as a list of ongoing items to bring forward to future meetings.  In addition, minutes will be circulated for review within a couple of weeks after each meeting.

VA Playbook

 

Dr. Washburn presented a detailed outline of the playbook, and the entire draft document was circulated in advance of the meeting for review.  There was a lengthy discussion about industry research that doesn’t go through VA NPC for contracting/funding administration, particularly with medical device research and/or unfunded research.  Ms. Caroff recognized the need for a separate VA research primer that would include such topics as:

• ·        What qualifies as VA research
• ·        Roles of VA programs and staff members in VA research
• ·        Guidelines for unfunded research

It would be helpful to add more detail to the playbook regarding the following topics:

• ·        The relationship between VA as the NPC.  NPCs can be misperceived as the gatekeepers to VA researchers, and we need to emphasize that NPCs exist to provide administrative resources and efficiencies, and support compliance with VA guidance regarding research contracting and regulatory compliance.
• ·        The ability for a sponsor to pursue relationships with VA investigators at the same time they’re working with NPCs on contracting/budgeting issues.

NAVREF Member Directory 

Ms. West and Mr. Tran presented the 2023 NAVREF Member Directory for review and comment.  Individual member profiles include contact information, areas of research interest, number of unique patients, information about local research infrastructure, and investigators of note.  The following recommendations were made for future versions of the member directory:

• ·        Break out cancer research interests into subgroups (i.e., lung, prostate, etc.)
• ·        Merge NPC directory with broader VA medical center information
• ·        Add contact information for contracting and budgeting
• ·        In directory introductory information, add updated areas of national focus for VA research
• ·        Identify sites that are participating in VA Lung Precision Oncology Program (LPOP)
• ·        Add contact information for investigators of note
• ·        Add demographic information for local patient population
• ·        Add information about multisite NPCs
• ·        Add VISN information
• ·        Allow individual NPCs to update information in real time throughout the year
• ·        Allow search functions so that it’s easier to identify sites with certain characteristics
• ·        Link NPC profiles to NAVREF website map of member NPCs

VA Data Access

Ms. West presented an update on obtaining access to VA data to support clinical trials.  Upon review of the potential VA data sources mentioned at the December 2022 IPC meeting (National Center for Veterans Analysis and Statistics and the VA RAMP Open Data Portal), the data were found to be either inaccessible to outside organizations, or outdated and not in a useful format.

Since the last IPC meeting, there have been several conversations with VA leadership regarding the use of VA data to support clinical trials access for veterans.  While there is universal support for the idea, it would be precedent setting to allow the use of data by outside entities for this purpose.  Therefore, it’s unclear how to proceed in practice.  It would be possible to enter a CRADA agreement with VINCI, but they would charge NAVREF a high hourly rate ($250+/hour) for data analysis services.  The VA National  Artificial Intelligence Institute (NAII) has previously expressed interest in sharing resources with outside entities, so we will propose NAVREF funding of a 0.5 FTE data analyst position within NAII for two years.  This would give VA control over the types of data released to NAVREF and address VA concerns about data confidentiality.  The goal for this two-year trial period would be to test the utility of VA data for supporting clinical trials, and establish the effort required to provide different types of information.

Diversity and Equity in VA Clinical Trials

At the last IPC meeting there was enthusiastic support from Committee members to develop efforts in this area.  An IPC Diversity Equity and Inclusion (DEI) subcommittee was formed to start researching current efforts in this area, and determining how the IPC might best contribute.  DEI subcommittee members include:

               Sarah Abdella-El Kallassy (VA National Artificial Intelligence Institute)

Krissa Caroff (VA Partnered Research Program)

               Allyson Gage (Cohen Veterans Bioscience)

               Waqar Malik (Wisconsin Corporation for Biomedical Research)

               Priscilla West (NAVREF)

               Rochelle Williams-Belizaire (Mirati)

The DEI subcommittee will meet monthly and will present their findings and recommendations at the next IPC meeting.

Action Items for June 2023 Meeting

• ·        Revise VA Playbook to incorporate feedback from today’s meeting.  Send final draft to VA Partnered Research Program for final review and comment.  Present final draft to IPC members at June meeting.
• ·        Pursue NAVREF funding of 0.5 FTE data analyst for two years within VA, dedicated to the use of VA data to support clinical trials.
• ·        Present findings of the IPC DEI subcommittee and recommend possible activities to support diversity and equity in VA clinical trials.
• ·        Present mock-up of Industry Partner portal on NAVREF website for feedback
• ·        Determine status of VA patient clinical study volunteer registry

Ongoing Items

 

• ·        Work with Krissa Caroff on VA research primer
• ·        Develop summary of potential methods of supporting decentralized clinical trials for VA consideration

Written by: Priscilla West, MPH

The NAVREF Industry Partner Consortium (IPC) held three meetings during the past year.  An Executive Committee for the IPC was developed to help focus and prioritize the broad interests of the group.  The charter members of the Executive Committee include: Peggy Bradley (Executive Director, Biomedical Research and Education Foundation of Southern Arizona), Angie Smith (Executive Director, North Florida Foundation for Research and Education), Caroline Zink (Executive Director, Baltimore Research and Education Foundation), Sean Cunningham (Janssen), Theresa Devens (Eisai), and Allyson Gage (Cohen Veterans Bioscience).

At the most recent IPC meeting in Miami on December 6-7, conversations continued about decentralized clinical trials (DCTs), and how they might best work for VA sites.  Decentralized clinical trials are characterized by less dependence on traditional clinical research infrastructure, and more on virtual communication tools like telemedicine, patient-driven communication devices, home health visits (or visits at ancillary facilities closer to the patient’s home), and direct mailing of study medications and other study materials to the patient’s home.  The Covid pandemic led to strong interest in developing DCT methods, and the IPC is discussing how some of these methods might improve veteran access to clinical trials and their satisfaction with the research experience. 

The IPC Miami meeting also included a discussion about consistent access to VA data to provide support to NAVREF members, VA researchers and clinical trial sponsors in the following areas:

• ·        Identification of prospective study sites for new or expanding studies
• ·        Prescreening potential study subjects for existing studies

We will move forward with contracting with the VINCI program to provide these services for NAVREF members.  During the first year, it will be important to establish the level and scope of demand so that we can best tailor services for future years. 

Our IPC industry colleagues identified the need for a VA clinical trial ‘Playbook,’ describing the VA processes for reviewing and approving clinical research in lay terms (including a dictionary of VA research-related acronyms).  A big thank you to Katrina Washburn (Executive Director of the South Florida Veterans Affairs Foundation for Research and Education), who volunteered to take the lead on drafting this document.

The Miami IPC meeting wrapped up with a discussion about how we can best support diversity and equity in VA clinical trials, including gender, race, and geographic distribution/rurality of study subjects.  Industry partners noted that the US Food and Drug Administration also has strong interests in promoting equal access to clinical studies.  There was unanimous support for this effort, and we will be reaching out to other government and nonprofit agencies to assist us in developing effective strategies to strengthen equity in clinical trials access and participation.

Dedicated to all the Veterans willing to continue service to their nation through research.