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William Hartman, MD, PhD, hasn’t only been on the front lines of the global pandemic – he’s been at the forefront of U.S. clinical trials to treat and vaccinate against COVID-19. In this ASA Community Member Spotlight, he takes us behind the scenes of the truly team effort that has produced positive results in patients running the social gamut, from underserved communities to the former President of the United States. Here’s why he says an anesthesiologist is the ideal person to lead clinical trials during a pandemic.

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Please tell us about your work on COVID-19 research and therapeutics. How did you get involved with this effort?

A year ago, when COVID-19 was starting to cause havoc in several U.S. cities, we didn't have a single therapeutic option available to help those who were sick and dying. I’d heard that my colleague, anesthesiologist Dr. Michael Joyner from Mayo Clinic in Rochester, was leading an effort in the U.S. to utilize convalescent plasma to treat hospitalized patients. I spoke with Dr. Joyner on the phone and through emails and he strongly encouraged me to start a convalescent plasma program at University of Wisconsin-Madison. He planted the seed, and we were able to grow it.

At Madison, we wrote the workflows and protocols for getting plasma from donors to patients twice - first by utilizing the FDA eIND process and then via the Mayo EAP, which eased the administrative burden and allowed us to get plasma to patients much faster. In cooperation with local and national media and the American Red Cross, we were able to identify donors, test them for COVID, get them a donation appointment, collect and test the plasma, and have the plasma ready to transfuse in our patients just 15 days after the concept was first proposed.

UW-Madison and its Office of Clinical Trials did an incredible job developing the plan and getting it working in such a short period of time. The people of Madison, WI, were incredible as well; for the first several weeks of the pandemic more than a third of the national supply of convalescent plasma came from Madison, and the city continues to supply large quantities of plasma nationwide.

From there, we soon looked for outpatient treatments for COVID and partnered with Regeneron to test their new monoclonal antibody cocktail in inpatients, outpatients, and as a prophylaxis medicine for household contacts. As people began to understand the power of this medicine and how and when to use it, this trial did very well. Recruitment reached new heights after President Trump was treated with it and declared Regeneron a "cure."

We then looked to see if we could handle a vaccine trial, as the vaccines were going to become the key to get out of the pandemic. Our Office of Clinical Trials again stepped up to the plate and we were able to host a high-volume, extremely involved vaccine trial in partnership with Astra Zeneca. In a year’s time, we had participated in two clinical therapeutic trials that produced emergency use authorization (EUAs) and a vaccine trial that could apply for an EUA in the next month. We have worked every day since March 2020 to ensure we were bringing the most effective treatment protocols to UW-Madison and to gather and evaluate the data needed to ensure these treatments could be used to help save lives. 

I’d like to add that in my opinion, Dr. Joyner at Mayo Clinic should be nominated for a Nobel Prize in medicine or perhaps even the Peace Prize for the way he was able to start, in grassroots fashion, a movement that reached every state and many countries, asking individuals to come together for the common cause to help save lives. He asked and people listened - easily the most organized and impressive feat I have ever experienced in medicine.

There are plenty of virologists and infectious disease experts dedicating themselves to COVID research. Why do you think an anesthesiologist is particularly suited to running clinical trials during a global pandemic?

An anesthesiologist is the ideal person to lead clinical trials during a pandemic. We spend our lives working in chaos to produce happy endings. Who better to lead trials in pandemic times? We’re able to develop and execute plans, adapt to difficult challenges, and do it all with the calmness that defines our profession. Large trials such as the ones I have led also require the ability to bring experts from many disciplines together to discuss plans and pitfalls of what could lie ahead. An anesthesiologist does this daily.

What’s the role of mentorship in medical research? What impact has mentorship had on your own research?

We train for years to be good, competent, skillful physicians. We spend a lot of time honing our clinical craft, but not as much time learning how to manage people or do research. These are also very important to our specialty, and I am grateful to have had wonderful mentors in these areas.

I can’t say enough about the leadership and mentorship I received this year from Dr. Michael Joyner and his collaborator, Dr. Arturo Casadevall of Johns Hopkins. Mike was always a phone call or text message away, no matter the time of day. He provided advice and support constantly. He was the definition of “humanitarian.” His influence on me was profound, and I worked diligently both to match his work ethic and to imitate his desire to help those around him, not just through the plasma program but also by teaching other hospitals how to set up their programs and utilize the EAP.

Through the years I have also met other fantastic mentors who taught me how to interact with people. Folks like my residency program director Steve Rose and my former chairman Mark Warner have tremendous people skills and taught me how to interact with people with honesty and compassion, skills that served me well as we put together groups of experts to work together during a pandemic. Finally, my supervisor at Kaiser Permanente-Colorado, Dr. Michael Sawyer, showed me how to put together an agenda, run a meeting, and give people a chance to voice their opinions and provide input. He taught me that everyone in the meeting is there for a reason and everyone has something to offer so make the most of everyone’s talents.

All of these “soft” skills proved very important when setting up trials during a pandemic. I am grateful to each of these people for the mentorship and certainly hope that I can pass these skills onto the next generation. In fact, I believe I am obligated to pass these skills on to the younger faculty members. 

Convalescent plasma was one of the first widely available treatments to receive emergency use authorization by the FDA. How important is it that COVID treatments and vaccines be distributed equitably? What’s at stake?

When Convalescent Plasma received its EUA, the administrative burden of the EAP was removed and plasma could be transfused outside of a clinical trial. This made plasma available to everyone everywhere and bridged an important health inequity gap. It didn’t matter if you were rich or poor, at a high-powered academic institute or an inner-city community hospital. Everyone had equal access to a very important resource that was showing evidence of saving lives.

COVID has been particularly harmful to certain communities of color. One in 630 Black people in this country has died from COVID. Figuring out ways to equitably distribute treatments and vaccines was incredibly important. Treating and protecting all people in every community must be prioritized. This virus has harmed many families and many communities. Narrowing existing gaps in health equity will not only help us rise from this pandemic; it will make us a stronger and more unified country.

What are you working on now? Are there any avenues of research that you find particularly exciting?

We are working daily to collect and enter all of our data from our COVID vaccine trial participants. With enrollment completed, we are working day and night to get all of the information turned in so that we can get answers as to the safety and the efficacy of the vaccine which, if results are good, could enter the vaccine pool with an EUA application in April.

While we finish this phase of that trial, we are getting ready to see if plasma collected from vaccinated individuals can be used therapeutically in patients sick with COVID-19. We are also looking at bringing a pediatric COVID vaccine trial to Wisconsin, a necessary and important trial that will be needed for us to put the pandemic in the rearview mirror.

The most exciting part of all of this has been watching people come together to fight this virus. At UW-Madison, my colleagues have covered many of my shifts in the OR so that I can manage these trials. I couldn’t do any of this without their support. And I can’t say enough about the Office of Clinical Trials. I have said many times that they are the best in the business. In an unprecedented time, they bring an unprecedented effort every day to coordinate these life-saving trials. They know what is on the line, and they deliver time and again. I am so very lucky to work alongside these amazing people.

Is there anything you’d like to add that we haven’t yet touched on?

A little bit about me: I am lucky to have worked at some amazing institutions (Mayo Clinic, Kaiser Permanente-Colorado, and University of Wisconsin-Madison) and alongside wonderful people who are leaders and trailblazers in our field. But none of this would have been possible without the support I get at home from my best friend and wife, Ann, and our five children. I never have to go looking for encouragement or reasons for hope, they surround me when I walk into my home. I live my best life every day.

William Hartman, MD, PhD, is Assistant Professor in the Department of Anesthesiology at the University of Wisconsin School of Medicine and Public Health. Read more about his clinical research here.