During the COVID-19 pandemic, Argo Pond provided research strategic advising and clinical trial oversight to research teams across the US. We are excited to present a series of interviews with some of these researchers, who effectively conducted clinical trials during a remarkable moment in history. In this blog, we speak with Drs. Emma Meagher and Ian Frank of the University of Pennsylvania.
Dr. Emma Meagher
Professor, Medicine and Pharmacology
Vice Dean & Chief Clinical Research Officer
Senior Associate Vice Provost for Human Subjects
Dr. Ian Frank
Professor, Medicine and Infectious Diseases
Director, Clinical Cores, Penn Center for AIDS Research
Perelman School of Medicine
University of Pennsylvania
The Leaders and their Roles Prior to the Pandemic
Emma Meagher, a cardiologist and clinical researcher by training, is the Vice Dean for Clinical Research and the Perelman School of Medicine and the Senior Associate Vice Provost for Human Subjects Research at the University of Pennsylvania. She considers herself foremost an educator, and at Penn she leads the institution’s clinical research mission and a translational research training program that has enjoyed over 20 years’ NIH funding. In her Vice Dean and Vice Provost roles, she devotes her time to implementing Penn’s clinical research strategy by making clinical research easier and more impactful for Penn’s many life scientists while managing the risks that accompany studying diseases and their treatments in people.
Ian Frank is an infectious disease physician who leads the Perelman School of Medicine’s HIV Clinical Trial Unit, where he supports HIV research across the university. He also heads the Clinical Core at the Penn Center for AIDS Research which integrates the health system’s extensive HIV treatment and prevention program with virologists, immunologists, and other researchers. Ian provides leadership nationally and internationally for clinical trials in patients with HIV, in particular efforts to develop an HIV vaccine. As Ian also directs the infectious disease clinical service, he found himself at the clinical and research epicenter of the pandemic over the past year.
When They Understood the Magnitude of the Coming Pandemic
On January 28th, 2020, Emma was visiting several of the University of California schools when COVID-19 started quickly changing from a few cases in Washington state to early outbreaks in several cities. She suddenly became worried that air travel might shut down. Ultimately, she was able to travel, but prior to leaving the west coast she participated in “what if” conversations at UCSD as they considered what they were facing. That conversation prepared her for a similar conversation that followed at Penn upon her return. Sitting in her home the evening after the first planning meeting is when it really struck her what might be about to happen. ‘The feeling that there was always another shoe to drop was so unnerving in the earliest days.’
Ian’s first impressions about the pandemic drew from his previous experience with the SARS-CoV-1 epidemic in 2002-2003 the SARS-CoV-1 epidemic. That coronavirus outbreak, which also emerged in China, mostly extinguished itself within a few months. Although the illness was severe, its infectivity was significantly less. Ian’s view began to change as he watched the first wave of SARS-CoV-2 strike New York. ‘It was clear it was going to be a huge problem. Looking at the map, you could see the infections spreading out of New York. You knew we were going to be part of the wave. We were all waiting for it.’
Their Biggest Challenges During the Pandemic
For Ian and Emma and the large group of investigators they support, the biggest initial challenge was worry. “Early on we were scared – we didn’t know how dangerous this was. We worried about our health and our families’. Some researchers wouldn’t go home at all- others stayed in one room in their home away from everyone else.” Additionally, the new contact precautions and procedures slowed everything down. Consenting a patient to participate in a clinical trial could require a researcher spend more than an hour in a contagious patient’s room; simple blood draws and other tests suddenly involved multiple people and required special planning to minimize team exposure.
Just as clinical care had to be reconfigured almost overnight, research teams had to be re-oriented and quickly expanded. To accommodate Penn’s pivotal role in vaccine development, Ian’s HIV vaccine staff had to be doubled in just a few weeks. All the recruiting, hiring, and orientation which usually required weeks had to be compressed into days. The entire team was never in the same room at the same time.
A challenge neither expected was the number of therapeutic trials being suggested by the Penn faculty. Emma remembers that every day 3-4 new clinical trial proposals would cross her desk. She and Ian established a clinical trial oversight committee to evaluate and approve or decline new trial ideas as they came forward. This was an especially time-consuming and exhausting new role. “One of the most difficult aspects of that job was having to tell scientists no, you can’t do that work. We do not work in a culture where ‘no’ is a very easily accepted answer. A lot of people had good ideas that couldn’t be pursued.”
For Ian, “it has been an enormously exciting opportunity, to be part of a really important new infection. Most days, we’re more excited than scared.” One of the things Ian found most exciting has been the speed of innovation over the past year. This includes not only the accelerated advances in biotechnology and especially vaccine technology, but other innovations that will improve the care of his patients. Telemedicine has transformed how he cares for patients with HIV and other long-term patients, especially those in rural areas. “I have a lot of patients that come to see me from southern Delaware or central Pennsylvania. Now, rather than have them drive for two hours I can interact with them through telemedicine. We’re never going to do visits the same again.”
But for both physicians, the emotional cost has been substantial. Like many people, Ian was unable to see his kids – and a new grandson – for months. “I honestly don’t know,” reflected Emma, “how we got through it. I learned so much about what you could pull out of the bag if you had no choice. But when I think back on it, I feel a level of sadness about so many things that were missed – it can be too hard to think about.”
The Role of Research Institutions During Public Health Emergencies
A central question that arose during Argo Pond’s work with Penn during the pandemic is what is the role for such a large research university and health system should be in advancing new therapies for the infection? Ideas for new therapies were almost unlimited among the Penn faculty, but the number of patients available for research participation – and the infrastructure needed to enroll and care for them – was finite. Would the school’s scientific and clinical resources best be deployed by contributing to large multicenter trials? Or by pushing the envelope by studying therapies that were probably too early to make an impact on the current pandemic but might play a major role in the future? Emma notes, “There’s not a real answer. I think we’ll always struggle to make decisions about prioritization. A large university’s mandate is so broad, and in that moment, every pillar needs attention. Academia’s long arc produced the technology that became antibody therapy and vaccines for COVID-19. Yet in the chaos of times like this past year, we will be challenged like all large institutions in how to most effectively deploy limited resources.”
Ian is grateful for the research teamwork that profoundly changed the world this past year. “What we’ve really seen is the importance and power of multicenter trial networks. The national HIV and infectious disease collaborative networks were quickly repurposed to evaluate the antibody and vaccine therapies that are saving millions of lives.”
A change Emma would like to see? The importance of research teams, and team science, in defending against the pandemic has been center stage. Yet academia historically most strongly acknowledges individual achievement. “If there’s one thing that we can improve right now, it’s how we as a university think about our recognition and reward structure. Most clinical research is a team effort – now is the time to really celebrate this expertise and enable the careers and promotion opportunities for clinical scientists at Penn.’