Rachel B. Ramoni, DMD, ScD, is the chief research and development officer (CRADO) for the Department of Veterans Affairs (VA). Rachel assumed her role in January 2017. She is responsible for developing and executing the strategy for VA’s nationwide research enterprise, which encompasses more than 2,200 active projects at more than 100 sites. VA research is supported by a nearly $2 billion budget (fiscal year 2019), which includes both direct VA support and research funding from outside entities, such as the National Institutes of Health (NIH), other federal agencies, and nonprofit and private organizations.

Rachel has a longstanding commitment to patient-centered return on investment. This is reflected in her three strategic research priorities: (1) increasing veterans’ access to high-quality clinical trials, (2) increasing the substantial real-world impact of VA research, and (3) putting VA data to work for veterans. She has overseen the implementation of an array of initiatives to advance these priorities, including joint efforts with the National Cancer Institute (NCI), Department of Energy, Prostate Cancer Foundation, and numerous other federal and non-federal partners.

 

Dr. Rachel Ramoni.

 

Rachel previously served on the faculty at New York University College of Dentistry in the Department of Epidemiology and Health Promotion and at the Department of Biomedical Informatics at Harvard Medical School.

While at Harvard, Rachel established and led the Undiagnosed Diseases Network (UDN) Coordinating Center. The UDN, funded by the National Institutes of Health, brings together clinical and research experts from across the United States to solve challenging medical mysteries using advanced technologies. The Boston Globe called the network a “powerful new way to diagnose mystery illnesses.”

Prior to her work with the UDN, Rachel was executive director of the Substitutable Medical Applications, Reusable Technologies project, or SMART. It resulted in the SMART on FHIR (Fast Healthcare Interoperability Resources) technology, which enables electronic health record apps to be developed once and run across disparate systems. This technology is now broadly used by companies like Apple, Cerner, and Epic.

 

 

Rachel earned a Doctor of Medicine in Dentistry degree from the Harvard School of Dental Medicine, as well as a Master of Science and Doctor of Science in epidemiology from the Harvard School of Public Health. She also holds certificates in dental public health and oral epidemiology.

 

Veterans Affairs & Military Medicine Outlook: You came to VA in 2017. How did you go about identifying the Office of Research and Development’s (ORD) top research priorities: increasing veterans’ access to high-quality clinical trials, increasing the real-world impact of VA research, and putting data to work for veterans?

Rachel Ramoni, DMD, ScD: I came up with a first draft of these priorities in 2018, about a year after I joined VA. In the previous year, I got to know the organization well, both in the central office, where I work, and in the VA medical centers, where the research takes place. I shared the priorities with members on the Hill and also with leadership in VA. Perhaps it’s because they are so obviously rooted in things that we should be doing that they were quite directly embraced. It was in 2018 that these were first articulated.

 

Was there anything about your previous experience in research and health care that informed the process of determining these priorities?

Most of my career has been spent in the field of informatics. Prior to starting my job at VA, I worked on a project called the Undiagnosed Diseases Network, which is focused on diagnosing individuals with mysterious medical conditions. In terms of the first priority – increasing veterans’ access to high-quality clinical trials – in the world of undiagnosed diseases, oftentimes clinical trials offer people the only hope. And we now have a big focus on precision oncology, particularly on prostate cancer. There are no approved drugs to treat metastatic prostate cancer. These trials offer hope to people when standard clinical care has been exhausted as a possibility.

The second priority, which is to increase the substantial real-world impact of VA research, is also informed by other work that I have done, which has been aimed at getting research to the point where you can help people. This is well tied in with the history of VA. We are embedded in one of the largest health care systems in the country, so we have a special responsibility to make sure that our research is not only published but creates innovations and discoveries that benefit our veterans. That also draws from my work with the Undiagnosed Diseases Network, where it was always so exciting when a new discovery was made, but then the next question would be: “How does this help people?”

And the third priority, putting VA data to work for veterans, is quite directly drawn from my experiences at the Department of Biomedical Informatics at the Harvard Medical School. There, I saw firsthand the power of data to improve people’s lives. I want veterans to benefit from that.

 

Were there other reasons why you identified access to clinical trials as a priority?

VA has a long history of conducting multisite clinical trials. The Cooperative Studies Program has brought great innovations to the world, such as aspirin as a preventive measure for secondary heart attack, and the massive clinical trial that led to the first shingles vaccine being approved for use in the United States. And we’re now conducting trials, for example, on non-pharmacologic approaches for pain, as well as sleep in the context of PTSD.

At the same time, I’ve heard from pharma companies, which are the source of a lot of these treatments, that VA had a reputation for being difficult to work with. I thought: Well, that is not great news for the veterans who could benefit from these studies.

 

Difficult how?

For instance, the average time it took to start up an industry-sponsored VA trial was 285 days, when the average around the country for academical medical centers was around 150 days. We have committed to be a hundred days faster by the end of fiscal year 2021, to even the playing field and make sure people see VA as a place where they can bring their most innovative treatments to veterans.

 

What are some of the things VA needs to do to make that happen?

I think one of the things that makes us such an important partner is also what has made us more challenging to work with – which is just the scale of VA. There are 170 medical centers, and they often develop some of their own ways of doing things. A lot of what we’ve been working on is rolling out more standardized approaches. For example, we are putting into place a VA-wide system for IRB [Institutional Review Board] review, to review studies for human subjects’ protection. This system will ensure standardized forms and processes across all VA medical centers, so that if you want to start up a study at 10 different sites, you don’t have to fill out 10 different sets of forms. This reflects my emphasis on creating a research enterprise that looks at the VA as a whole, rather than having 170 separate medical centers.

 

Dr. Bruce Montgomery, an oncologist at the VA Puget Sound Health Care System in Seattle, Washington, meets with Navy veteran Allen Petchnick, whose metastatic prostate cancer has been effectively treated to date with targeted therapy. The advanced level of medical care Petchnick received was made possible by a partnership between the VA and the Prostate Cancer Foundation.

 

VA’s budget proposal also mentions partnerships, such as the new NAVIGATE partnership with the National Cancer Institute, to get more veterans into trials that aren’t necessarily funded by VA. Are there similar projects in the works?

We have two strategies for increasing veterans’ access to high-quality trials. One is to make the process of starting a trial more efficient. The other is to strengthen the support and infrastructure you need to nourish these clinical trials. One of the partnerships we made was with the National Cancer Institute, which awarded funding to 12 sites across the VA to help support staff and to enroll more veterans into NCI sponsored clinical trials. At the same time, the Prostate Cancer Foundation made a commitment to VA of $50 million to do the same thing for our prostate cancer trials. That project is called POPCaP – the Precision Oncology Program for Cancer of the Prostate.

 

In this 2015 photo, World War II Marine veteran Stanley Frable, who took part in the COURAGE trial, meets with Dr. Steven Sedlis, then the chief of the cardiology section at the Manhattan VA Medical Center. The VA is working to implement findings from the COURAGE trial.

 

At this time, there are 10 POPCaP sites around the country. POPCaP’s initial focus is metastatic prostate cancer, cancer that’s spread to other parts of the body. It’s first of all ensuring that these men get genetic testing – it’s been found that a significant proportion of men with metastatic prostate cancer have genetic variations that predispose them to the cancer and also make them more likely to respond to certain treatments.

We’re making sure these men get the sequencing they need so they can get access to the promising treatments through clinical trials.

 

For the second priority you’ve identified – increasing the substantial real-world impact of VA research – how well do you think VA research translates into practice, compared to the work of other institutions?

I think VA is actually at an advantage in terms of getting research findings into practice, because we are a large research program embedded in a health care system. Often, the research ideas we get come from clinicians who practice in the VA. And a lot of those clinical leaders are being brought in early in the planning phase of the study to make sure that when it’s done, it’s ready to transition over to the clinic.

For example, this is something we’re working on now to implement findings of two studies: the VA COURAGE trial, and another funded by NIH called the ISCHEMIA trial. Those studies both found that in certain circumstances, with chest pain, it’s no worse to have intensive medical management, rather than get a stent, which can be associated with complications. We’ve started working with our national program director in cardiology, Dr. Richard Schofield, and talking about what this means for VA patients – how we can make sure this research goes on to benefit people – and at the same time isn’t inappropriately understood to mean that stenting is never the answer, because of course there are many circumstances in which that’s the best possible treatment.

I used to be an academic at Harvard. There, I didn’t have the advantage of being able to call up the head of cardiology at one of the largest medical health care systems in the country to say, “Gosh we have this finding, so how should we change our care on this basis?” It’s incredibly powerful to be able to bridge research and clinical care just by picking up the phone.

 

How do you envision the VA increasing this kind of impact?

A few ways. Number one, working more closely with the clinical teams at VA. We’re getting to know our clinical colleagues ever better.

The second is that we have a very active Technology Transfer Program in terms of generating intellectual property and ultimately leading to products. So, we – the Office of Research and Development – are focusing some of our funding now on developing some of the inventions made in VA. For instance, Tech Transfer has been working with the Human Engineering Resource Laboratories up in Pittsburgh to prototype some VA inventions, and working on getting more licensing agreements for these products – because you may have developed an important innovation, but unless somebody is going to produce it at scale, it’s not going to benefit people.

There is a new law called the Evidence-Based Policy Act that requires every agency to have a plan to use evidence in informing its budget and its policies. People on my team are working closely with the Office of Finance to bring their evidence to the budget decision-making process at VA. Just having a seat at that table is another way we’re using research and evidence to have an impact on how VA does its business.

 

The VA’s third strategic research priority is to put data to work for veterans. The VA probably collects more data than any other health care system. Where is it in terms of putting that data to work?

What we’re excited about is the potential to bring in expertise, both within the VA but also outside the VA, in a way, obviously, that respects privacy of our veterans and all the rules and regulations about the use of these research and health care data. We’re in the process of setting up a VA Data Commons, where de-identified research and clinical data will be made available to qualified researchers. The thinking is that if you bring the best minds to the data, then they are going to make discoveries that will benefit veterans. And we’ve certainly found that to be true in our initial and ongoing studies in the Million Veteran Program. Some of the early research articles that have come out from that project have been recognized as among the most influential of the year.

 

How are your priorities informing ORD’s response to COVID-19?

Prior to the COVID-19 outbreak, ORD was pursuing three strategic priorities, and we have continued focusing on these goals: increasing veterans’ access to high-quality clinical trials, increasing the substantial real-world impact of VA research, and putting VA data to work for veterans. These priorities have allowed us to rapidly respond to COVID-19 demands.

The VA Office of Research and Development’s response to COVID-19 is being guided by its strategic principles: increasing veterans’ access to clinical trials, increasing the real-world impact of VA research, and putting VA data to work for veterans.
In line with our first priority, enhancing veteran access to clinical trials, ORD has committed its resources to work closely with industry partners to expedite clinical trials that seek to understand and treat COVID-19.

We are coordinating with federal agencies like the National Institute of Allergies and Infectious Diseases [NIAID] on national studies to understand COVID-19 and to develop new treatments. Part of this effort includes collecting specimens from veterans infected with COVID-19 to aid in vaccine and therapeutics development.

 

 

Another example of current research: The VA medical centers in Palo Alto, Denver, and New Orleans are participating in an NIAID-sponsored clinical trial of remdesivir, one of the more promising medications for COVID-19.

VA is also part of a clinical trial with Regeneron Pharmaceuticals, to study the use of a drug called Kevzara to treat COVID-19. We started up that clinical trial site in under a week, thanks to the work that we have done over the last two years to streamline our processes.

Our second priority, increasing the real-world impact of research, is especially meaningful in the context of a new disease like COVID-19. It’s both motivating and humbling to know that it is only through research that we, the human race, will defeat this virus. We are working closely with our clinical partners across the Veterans Health Administration [VHA] to ensure that the clinical care we provide is based upon the best evidence available.

Guided by our third strategic priority, putting VA data to work for veterans, ORD is analyzing VHA health care data to provide important real-world evidence about whether drugs that have been developed for other purposes are effective in treating COVID-19.

 

What other opportunities do you see within the VHA, or in ORD, to capitalize on the potential of big data to transform care and improve veterans’ lives?

There is so much potential. We’ve chartered the National Artificial Intelligence Institute, a collaboration between our office and the Secretary’s Center for Strategic Partnerships. One of the things that we are looking at, for instance, is the ability to process images. In oncology, the hope is that you can use image processing to tell you something about which treatment a person may or may not respond to, based on those image characteristics. And there are some early data from researchers, both inside and outside the VA, that indicate this is a promising line of research. There is a tremendous amount of data in those pictures that our eyes alone can’t detect; that’s a really promising area for research.

We also want to develop our ability to partner with industry or with private entities. And one way the National AI Institute did this was through a Tech Sprint they recently ran to encourage outside entities to create applications to effectively use open data.

 

Putting data to work requires technology, and technology costs money – and for government agencies, funding always seems to be an uncertainty. How does VA plan to leverage its expertise to stay on the cutting edge of analyzing and putting data to work?

We do this, in part, by working with other government agencies. For instance, we have a collaboration with the Department of Energy to help us analyze and draw knowledge from Million Veteran Program data. The VA Data Commons, which I previously mentioned, is another approach to ensure access to up-to-date, cloud-based infrastructure that can expand with our needs. Our IT office has been very supportive of our developing this cloud-based platform. So, these partnerships, and these new technologies, are helping us approach this work in the context of IT budgets that naturally have limits.

Sometimes, when we talk about Big Data, the conversation can seem kind of abstract. So, let’s remind readers: In what ways has VA’s big data enterprise, things such as the Million Veteran Program, improved health care and the quality of life for veterans?
I always say I’m a very patient woman – and it’s a good thing, because research unfolds over time. Because of the large number of individuals that we have in the Million Veteran Program, for example, we’re able to identify new genetic markers for conditions – say, for cardiovascular disease. And that’s the beginning of a process that we hope leads to either new treatments or to more precise diagnostics for people.

We cover the full spectrum of research, obviously, from basic science all the way through to health services research. Our commitment to veterans is that when we find that basic science discovery, we say: “Well, how the heck is this going to help me, knowing that this variation is associated with cardiovascular disease?” It’s our job to take those findings and walk them along the research and development pipeline, to transform those insights into treatments or products that benefit veterans.

 

This story originally appears in Veterans Affairs & Military Medicine OUTLOOK.