about the act for veterans initiative
ACT for Veterans Steering Committee Meeting
What is this initiative?
Access to Clinical Trials (ACT) for Veterans is a multi-year collaborative effort designed to provide Veterans with increased access to industry sponsored clinical trials on innovative therapies within the VA health care system. The concept of this initiative began out of discussions between VHA’s Office of Research and Development (ORD) and the National Association of Veterans’ Research and Education Foundations (NAVREF) held in late 2017 in which it was noted that VA lacked a centralized, standardized system dedicated to initiating and conducting externally funded clinical trials efficiently.
Why is the initiative needed?
VA’s notable clinical trials tradition was borne out of a robust intramural research model that regarded research as the product of clinician-investigator inquiries arising while providing care to Veterans and capitalized on capabilities already existing within the nation’s largest integrated healthcare system. While parts of the system were developed to conduct trials with external partners, those processes were adapted through available capabilities and policies on a more study by- study basis.
With industry partners, the VA can bring new discoveries and the promise of novel treatments to Veterans. The VA is dedicated to building a network of stakeholders with shared goals that can work effectively to conduct successful, quality clinical trials to enable its healthcare mission for Veterans and ultimately the nation. Part of this effort is to establish a system that facilitates these partnerships. Pursuing this capability not only means that the nation can strengthen its ability to obtain better evidence on therapeutic approaches, but that Veterans will have more treatment choices and improved quality of life.
Accomplishments to date:
Looking Ahead: Spring 2020: Initiation of the Partnered Research Program
One of the key objectives for the ACT for Veterans Initiative was to establish a Single Point of Contact for potential partners within the life science industry. This goal has been accomplished with the creation of the Partnered Research Program (PRP) within VA’s Office of Research and Development which will be at initial operating capability in Spring 2020. The PRP will assist potential partners by:
If you are interested in supporting ACT for Veterans in any capacity, or would like to be added to our distribution list to receive monthly updates, please send an email to clinicaltrials@navref.org
Access to Clinical Trials (ACT) for Veterans is a multi-year collaborative effort designed to provide Veterans with increased access to industry sponsored clinical trials on innovative therapies within the VA health care system. The concept of this initiative began out of discussions between VHA’s Office of Research and Development (ORD) and the National Association of Veterans’ Research and Education Foundations (NAVREF) held in late 2017 in which it was noted that VA lacked a centralized, standardized system dedicated to initiating and conducting externally funded clinical trials efficiently.
Why is the initiative needed?
VA’s notable clinical trials tradition was borne out of a robust intramural research model that regarded research as the product of clinician-investigator inquiries arising while providing care to Veterans and capitalized on capabilities already existing within the nation’s largest integrated healthcare system. While parts of the system were developed to conduct trials with external partners, those processes were adapted through available capabilities and policies on a more study by- study basis.
With industry partners, the VA can bring new discoveries and the promise of novel treatments to Veterans. The VA is dedicated to building a network of stakeholders with shared goals that can work effectively to conduct successful, quality clinical trials to enable its healthcare mission for Veterans and ultimately the nation. Part of this effort is to establish a system that facilitates these partnerships. Pursuing this capability not only means that the nation can strengthen its ability to obtain better evidence on therapeutic approaches, but that Veterans will have more treatment choices and improved quality of life.
Accomplishments to date:
- April 2018: Stakeholder Summit
- June 2018: Identification of Top 5 Priorities for the initiative.
- Developing the single point of contact (SPOC) model to facilitate the communication of trial opportunities, processes, and requirements.
- Establishing a standard set of basic information that VA can provide to industry regarding VA assets (e.g., patients, investigators, capabilities, etc.) and processes (e.g., approvals, requirements, etc.) in order to initiate partnerships.
- Establishing a set of requirements that outlines the specific information that VA needs from industry to initiate conversations.
- Creating and maintaining a process map related to study start up (from initiation of the relationship through site initiation) which includes and delineates centralized functions from those that are local responsibilities.
- Developing the capability for the VA Central IRB to accommodate more industry-sponsored trials.
- August 2018: Initiation of Workgroups to Address the Top 5 Priorities.
- February 2019: Workgroup Summit
- July 2019: Piloting of Central Sign Off for Non-Disclosure Agreements
- January 2020: Implementation of Single IRB Mandate
- February 2020: Launch of the VA Innovation and Research Review System (VAIRRS)
Looking Ahead: Spring 2020: Initiation of the Partnered Research Program
One of the key objectives for the ACT for Veterans Initiative was to establish a Single Point of Contact for potential partners within the life science industry. This goal has been accomplished with the creation of the Partnered Research Program (PRP) within VA’s Office of Research and Development which will be at initial operating capability in Spring 2020. The PRP will assist potential partners by:
- Providing an overview of current study start up process.
- Connecting them with key offices or individuals.
- Disseminating information regarding clinical trial opportunities to VA investigators.
- Assisting in the identification of potential VA research sites/investigators
- Facilitating the negotiation and execution of Confidentiality Disclosure Agreements
- Serving as the liaison between sites and sponsors throughout the start-up process.
If you are interested in supporting ACT for Veterans in any capacity, or would like to be added to our distribution list to receive monthly updates, please send an email to clinicaltrials@navref.org