Challenges and Initiatives in VA Research Enterprise
The VA Research Enterprise faces institutional challenges in conducting industry and other studies, requiring collaboration and dedication from its diverse workforce. With a focus on advancing Veteran well-being, the enterprise upholds core values such as operational excellence, engaged people, and real-world outcomes. Initiatives like Access to Clinical Trials aim to enhance Veterans' access to quality trials, showcasing the enterprise's commitment to improving healthcare outcomes.
Download Presentation
Please find below an Image/Link to download the presentation.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author. Download presentation by click this link. If you encounter any issues during the download, it is possible that the publisher has removed the file from their server.
E N D
Presentation Transcript
Institutional Challenges to Standing Up Industry and Other Studies Rachel Ramoni, DMD, ScD, Chief Research and Development Officer (CRADO) Krissa Caroff, Program Manager, Partnered Research Program Office of Research & Development Discovery, Education, and Affiliate Networks Veterans Health Administration IRB & RDC Chair Meeting February 2023
You Are Part of an All You Are Part of an All- -Year Year- -Long All Star Team! Long All Star Team! We are affiliated with the top academic medical centers across the country. Many of our researchers are faculty there. We have dedicated non- profit corporations that add expertise and bring in millions of dollars of external funding every year. We are part of the largest integrated healthcare system in the country. We have an intramural research appropriation approaching $1 billion. We conduct research at ~100 VA medical centers across the country. Dedicated Institutional Review Board and Research & Development Committee members ensure the integrity and efficient conduct of VA Research. 2
Our North Star Values Our North Star Values The VA Research Enterprise is the entire research workforce cooperating to advance Veteran wellbeing. The VA Research Enterprise aspires to embody the following qualities: Unique Value Proposition: Leverage our position as the only Federal research entity devoted to Veterans interests and being embedded in the nation s largest integrated healthcare system Operational Excellence: Operate with streamlined processes, effective collaboration, high-quality customer service, and appropriate resources Engaged People: Composed of a vibrant, diverse research community united in our mission to improve Veterans well-being through research Integration: Cultivate relationships and partnerships that accelerate our ability to achieve our mission Real-world Outcomes: Define our success in terms of tangible real-world improvements in Veterans health and well-being 3
Access to Clinical Trials (ACT) for Veterans In 2018, we undertook one of our first enterprise efforts, ACT for Veterans. Purpose was to increase Veterans access to high quality clinical trials by lowering barriers to conducting multi- site trials in VA. A collaboration with the National Association of Veterans Research and Education Foundations (NAVREF) Kickoff meeting included clinical trial stakeholder groups including sponsors, contract research organizations, VA research services, VA affiliated non-profit corporations, investigators, etc. 4
Challenges and Accomplishments: Challenges and Accomplishments: Challenges raised: Lengthy start-up times compared to academic counterparts Lack of consistency and standardization across sites participating in multisite trials No singular source for information/guidance Accomplishments: Ability for ORD to sign off on initial confidential disclosure agreements Ability to rely on private/commercial IRBs Model for designating lead VA non-profit corporation Establishment of the Partnered Research Program 5
Single Point of Contact: Partnered Research Program Office Single Point of Contact: Partnered Research Program Office Launched March 2020 (accelerated by COVID-19 pandemic) Initial point of contact ( Gatekeeper ) for external organizations interested in partnering with VA on industry sponsored multisite clinical trials. Facilitating successful partnerships by: oConnecting external organizations with VA resources/stakeholders oServing as a resource to help navigate VA clinical research enterprise oUndertaking continuous improvement activities designed to: Support efficient, standardized and streamlined start up activities related to multisite clinical trials. Identify challenges and best practices Improve collaboration processes
Specific Ways the PRP Supports VA Participation in Industry Trials Specific Ways the PRP Supports VA Participation in Industry Trials Connect interested companies with VA clinical and scientific experts to assess viability of specific projects. Provide information and resources to stakeholders related to partnering with VA on multisite clinical trials Facilitate centrally executed Confidentiality Disclosure Agreements (CDAs) Facilitate Master Agreements (e.g., Master CDAs and Cooperative Research and Development Agreements (CRADA)) Collaborate with others in VA, VHA and ORD to identify challenges and best practices and, when appropriate, offer solutions (e.g., minimize inaction and bottlenecks)
What is NOT Within the PRPs Scope? What is NOT Within the PRP s Scope? The PRP is NOT designed to replace the vital role that sponsors, investigators, and facilities play. In any given multisite trial, the Sponsor (or their contract research organization) will work directly with VA sites regarding: Site feasibility Pre-Selection visits/questionnaires, etc. Required regulatory documents, IRB submissions, local reviews and approvals, training, etc. CRADA and budget
Industry Sponsored Multisite Clinical Trial Start Up Industry Sponsored Multisite Clinical Trial Start Up Reality Desired State 10
Experience Experience To date, PRP has engaged with industry on over 140 research opportunities. A number of policy improvements have been put into place to support VA s ability to more efficiently participate in multisite trials. Experiences have also highlighted a series of (site level) challenges. 11
One Vignette/Multiple Challenges One Vignette/Multiple Challenges Required Reviews and Timelines Required Reviews and Timelines The ABC Pharmaceutical Company has selected 8 VAMCs to participate in its new Phase III study of its compound in individuals with moderate heart disease. The company is working with the Partnered Research Program. To ensure that expectations are managed in terms of study start up timelines, each site has been sent a survey requesting information related to the required local reviews and approvals process when using the commercial IRB selected for the study. Here are examples of responses received from 3 VA sites: Site Will your site require any reviews in advance of your submission to Advarra IRB? Site 1 VA policy does not permit us to use a commercial IRB therefore we will not be using Advarra IRB. Site 2 We must have a preliminary information security and privacy review before we can obtain an Endorsement Memo from our Research Service. Once that is received. we can submit to Advarra IRB. Site 3 I don t believe that we have any required reviews, but I m unsure whom I should ask to confirm. 12
One Vignette/Multiple Challenges One Vignette/Multiple Challenges Required Reviews and Timelines (2) Required Reviews and Timelines (2) The ABC Pharmaceutical Company has selected 8 VAMCs to participate in its new Phase III study of its compound in individuals with moderate heart disease. The company is working with the Partnered Research Program. To ensure that expectations are managed in terms of study start up timelines, each site has been sent a survey requesting information related to the required local reviews and approvals process when using the commercial IRB selected for the study. Here are examples of responses received from 3 VA sites: Site What is the order or reviews that must occur at your site? Site 1 1. IRB (ISSO and PO will review as part of IRB since we use local IRB); 2. Once IRB approves- Research Safety; Once Research Safety approves, R&DC. Site 2 ISSO and PO reviews are first (they happen concurrently). Then once they do their reviews, and we get our endorsement letter we can submit to the IRB. Once we have IRB approval, we submit 1st to our Research Safety Committee and then to our R&DC. Site 3 I m pretty sure that we just submit to the IRB first. Once we have the approval, we will send it to our Research Office, and they will get any other reviews and approvals we need. 13
What These Responses Underscore What These Responses Underscore Variability/lack of consistency in local processes is difficult for sponsors to understand or manage. Study teams lack of knowledge leads to inadvertent misrepresentation of policies and procedures resulting in frustration, delays and redundancy Lack of knowledge about resources may result in delays and redundancy 14
How Can You Help? How Can You Help? Where are there opportunities within your facility, committee(s), etc. to work more efficiently? Where are there gaps in knowledge or process and how might you lean on others to fill them? How can you foster collaboration and learning between facilities? What is working well at your facility and are you sharing it with others? What do you find challenging or frustrating when presented with industry sponsored multisite clinical trials?
Key Questions/Considerations Key Questions/Considerations- - Local Processes What are your local review and approval processes? Where is this information maintained and is it available to: Committee Chairs, Committee Members, Research Staff. Others? How are new staff (investigators, coordinators, committee members, etc.) made aware of these materials? Do you have a directory of who s who and is this publicly available? Do you have a mechanism whereby procedures and associated timelines are routinely reviewed and evaluated for accuracy? Have you revised your SOPs to accommodate use of a single IRB? Commercial IRB? Are you introducing redundancy (e.g., local policy requires local IRB to review/sign off on a study where you ve already agreed to rely on an external IRB)? Local Processes 16
Key Questions/Considerations Key Questions/Considerations- - Training, Education and Available Resources Training, Education and Available Resources Do you, your committee members, researchers and staff know how to access the various resources ORPP&E creates? Does your facility offer any specific training beyond CITI based training for its research community? 17
Key Questions/Considerations Key Questions/Considerations- - Communication Communication How are important changes in procedure and/or local research policy communicated to researchers and their study teams? How are important changes in procedure and/or local research policy communicated among committees, chairs, reviewers? How often do you communicate with other IRB and/or R&D Committee Chairs? Do you have a mechanism for managing complaints and concerns? How do you share central office level changes/updates? 18
THANK YOU! 19
Questions and Requests for Information For sponsors: Requests for Collaboration should be initiated via PRP webpage electronic inquiry form (https://www.research.va.gov/programs/partnered_rese arch/request.cfm) For staff: General requests for information/guidance can be submitted via email to PartneredResearch@va.gov OR Contact: Krissa Caroff, PRP Program Manager, Krissa.Caroff@va.gov 20
