- - Tuesday, October 29, 2019

Less than 2 percent of clinical trials involve veterans’ hospitals. Here’s how to fix that.

New life-saving therapies are first made available through clinical trials. But there’s a problem: Our nation’s nine million veterans are the first in harm’s way but last in line for cures. Many clinical trials at U.S. Department of Veterans Affairs (VA) hospitals never even get off the ground, denying veterans access to innovative and potentially life-altering research. And it’s time for the agency to act.

Let’s look at the challenge first. For many patients with post-traumatic stress disorder or traumatic brain injury, investigational therapies can be the best hope, while for patients with cancer they are often the last hope. So, what happens when a study does not open in a VA facility? A veteran is denied a real shot at a cure.

For those veterans for whom a clinical trial is the only remaining option, this lack of access can sometimes mean the difference between life and death. Without better treatments for the invisible wounds that continue to impact so many of our veterans, we cannot effectively combat the suicide epidemic.

Why isn’t the research being conducted? It comes down to time and commitment. VA protocol review and approval processes are complicated. Clinical trials at VA hospitals take on average about 120 days longer to activate than non-VA sites.

Because of these lengthy delays — which can cost companies millions of dollars per day — many of our country’s leading pharmaceutical companies do not even attempt to bring clinical research to the VA and have not done so for decades. When sponsors are unable or unwilling to conduct studies at VA sites, it means that veterans lack access to the frontier of medicine for many diseases.

The result is alarming: Over the last three years, less than 2 percent of clinical trials sponsored by pharmaceutical companies included VA hospitals, according to one industry estimate.

We believe that with targeted reforms, the VA can decrease the average site start-up time by 100 days, which would put it on par with other world-class research institutions. With each reform, more VA facilities will be able to attract clinical trials, making cutting edge treatments available to a wider cross-section of veterans across America.

First, VA must provide a singular point of contact to facilitate and streamline multi-site clinical trial start-ups across VA hospitals. Pharmaceutical companies routinely complain that the clinical trial startup process in VA is fraught with unpredictability, they don’t know how to navigate the VA, and they receive contradictory answers as they bounce from one VA hospital to another. A single office properly staffed and resourced at the national level would cut through the red tape.

Second, VA should allow the use of commercial institutional review boards, or IRBs, in sponsored clinical research. IRBs play a critical role ensuring human research is conducted ethically and appropriately without causing harm to research participants. VA institutional review boards have a proud history of high-quality reviews that put the veteran’s well-being first. However, the extended time frame for these reviews exceeds typical industry expectations and have led pharmaceutical firms to avoid VA sites. Expanding internal capacity and using commercial IRBs will significantly improve timeliness.

Third, VA should provide clinician investigators with protected time to conduct clinical trials. Currently, VA clinicians who are awarded research grants from VA, the National Institutes of Health, or the Department of Defense are granted some portion of time during their 40-hour work week to devote to their research. Yet, no time is granted for interested clinicians to work on industry-sponsored clinical trials despite the enormous benefits these trials bring to patients, investigators and VA hospitals. Clinician investigators are forced to work nights and weekends on these studies, which serves as a disincentive that severely limits the potential pool of investigators and contributes to the low rate of sponsored clinical studies offered at VA hospitals. Granting protected time for sponsored clinical trials according to the same formula used for federal research awards is a small step that would have major positive ramifications to enhance veteran access to clinical trials at VA hospitals.

While the VA has already made encouraging strides, more needs to be done. Specifically, the VA secretary should endorse “100 days faster” for clinical trial start-up and resource it as an agency-wide initiative. He should designate a senior leader champion to clear all hurdles that stand in the way of achieving 100 days faster by 2021.

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, delays are devastating. It is critical that veterans be given the same level of access to these cutting-edge therapies as their counterparts outside the VA.

• Rick Starrs is CEO of the National Association of Veterans’ Research and Education Foundations (NAVREF). Roger Murry is executive director of the Coalition to Heal Invisible Wounds.

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