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Patient and Veterans advocates, industry leaders, and non-profits call on Congress to support “100 days faster” clinical trial startup at the U.S. Department of Veterans Affairs

5/21/2019

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Patient and Veterans advocates, industry leaders, and non-profits call on Congress to support “100 days faster” clinical trial startup at the U.S. Department of Veterans Affairs
May 16, 2019 - PRESS RELEASE
Contact: Roger Murry, Executive Director, Coalition to Heal Invisible Wounds

WASHINGTON, D.C. – A coalition of  organizations that support research at the U.S. Department of Veterans Affairs (VA) this week called on Congress to  support reforms at the VA to become “100 days faster” in clinical trial startup to ensure enhanced and timely access for our nations Veterans. “Clinical trial startup at VA sites averages more than 100 days longer than at non-VA sites,” according to the letter sent to Congress. “For Veterans suffering from post-traumatic stress disorder, traumatic brain injury, hearing loss, alcohol and other substance disorders, cancer,  and other conditions for which a clinical trial may be the next or only treatment option, these delays can restrict their access to these opportunities.”
The Coalition to Heal Invisible Wounds and National Association of Veterans’ Research and Education Foundations (NAVREF) organized the letter. Joining the letter were organizations that serve Veterans, including the Navy SEAL Foundation, Military Veteran Project, and NAMI Montana. Patient support groups signing included the Prostate Cancer Foundation, Veterans Against Alzheimer’s, and the LUNGevity Foundation, the nation's leading lung cancer-focused nonprofit. Representatives of the research community supporting the letter included PPD, Cohen Veterans Bioscience, Advantagene, and the Association of Clinical Research Organizations.
The letter continued: “As a first step towards ‘100 days faster,’ which we suggest the VA adopt as a reform mantra, we ask that the VA take all steps necessary to permit the use of commercial IRB [institutional review boards] accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). This policy revision would allow for a more predictable and timely IRB process.”
The letter seeks to engage congressional support for an ongoing effort co-led by the VA Office of Research and Development and NAVREF to improve access of Veterans to clinical trials. By setting an objective, measurable goal of 100 days faster, the VA can drive reforms throughout the clinical trial process, whether within the purview of ORD or not. Targeted reforms, beginning with allowing trial sponsors to use commercial institutional review boards, can bring VA’s practices in line with those of the leading clinical research institutions.
“Clinicians need better tools to treat and diagnose TBI and PTSD” said Roger Murry, Executive Director, Coalition to Heal Invisible Wounds, an advocacy coalition based in Washington, DC. “Smarter clinical trial startup procedures will broaden and speed up the development of new tools. With targeted support from Congress, and the concrete goal of 100 days faster, we believe VA can close the gap and change how the private sector views the VA as a potential clinical trials partner.”
“NAVREF appreciates ORD’s strong support of the ACT for Veterans initiative to enhance access to clinical trials for Veterans at VA medical centers, said Rick Starrs, the Chief Executive Officer for NAVREF. We want to see the entire Veterans Health Administration get behind the initiative to achieve the goal of 100 days faster for clinical trial start-up. Veterans deserve the opportunity to participate in these studies.”
More info can be found at healinvisiblewounds.org 

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stakeholder_letter_to_congress_va_clinical_trial_reform_may_2019.pdf
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