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 to provide Veterans with more access to industry sponsored clinical trials on innovative therapies within the VA health care system. Activities are focused on establishing a dedicated system for initiating and conducting these clinical trials efficiently within VA. 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 which later engaged several stakeholders with shared interests.
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.
What will the initiative do?
A Steering Committee has been established to help with organizing and providing direction for activities. This group is also responsible for engaging stakeholders in the process. Initial activities are focused on reviewing key considerations, regulations, and directives that apply to research and development in federal agencies (i.e. the VA) and considering bridge processes to facilitate industry partnerships. Additionally, based upon input from the various stakeholder groups, five key priorities for improving trial initiation activities were identified, and the Steering Committee commissioned five work groups, with designated leads and managers to focus on the following:
What can you do to help?
Here are a few ways that you can contribute to this initiative:
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.
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 to provide Veterans with more access to industry sponsored clinical trials on innovative therapies within the VA health care system. Activities are focused on establishing a dedicated system for initiating and conducting these clinical trials efficiently within VA. 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 which later engaged several stakeholders with shared interests.
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.
What will the initiative do?
A Steering Committee has been established to help with organizing and providing direction for activities. This group is also responsible for engaging stakeholders in the process. Initial activities are focused on reviewing key considerations, regulations, and directives that apply to research and development in federal agencies (i.e. the VA) and considering bridge processes to facilitate industry partnerships. Additionally, based upon input from the various stakeholder groups, five key priorities for improving trial initiation activities were identified, and the Steering Committee commissioned five work groups, with designated leads and managers to focus on the following:
- 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.
What can you do to help?
Here are a few ways that you can contribute to this initiative:
- Sign up for our monthly updates. Receiving and helping to communicate updates to others will promote efficiencies and harmonization across the system. Participate. We are looking for individuals and organizations who can contribute any of the following resources to the effort:
- Time. Can you spare some time to devote to this initiative? No matter how much or how little time you have, we need individuals who can support this effort by participating in workgroups, taking surveys, providing feedback on proposed workflows and solutions and more.
- Expertise. We need individuals representing various aspects of study start up to lend their knowledge. To be successful, we will need to rely on input from those who know and are willing to work with other experts to find solutions.
- Solutions. Often, best practices and other strategies for problems may already exist but are not known. We are eager to explore all options as we develop new and innovative ways for doing business.
- Money. Our April 12th Summit was made possible due to the financial support of generous sponsors. As we look to the future, there will be other events and opportunities with similar needs.
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.
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