Q&A: Stanford clinical researcher on COVID-19 vaccines, clinical trials

Jan. 27, 2021, 8:16 p.m.

Sumana Shashidhar is a clinical research manager at the Stanford Center for Clinical Research (SCCR). She and her team are conducting Phase 3 clinical trials for the Johnson & Johnson COVID-19 vaccine at Stanford.

The Stanford Daily (TSD): What influenced you to pursue biomedical clinical research?

Sumana Shashidhar (SS):  I grew up in India, and when I was really young, I read a book called “Microbe Hunters.” The idea of how the scientists before us did investigations and came up with vaccines to fight really deadly diseases at the time was something that really inspired me to go into biology. My foray was actually into microbiology, and over time, I just continued to follow the biological fields. I think it was a combination of the right time and luck that I stumbled into the biotech industry in 2001 or 2002, when there were a lot of startups and there was a lot of interest in the idea of personalized medicine. I’ve always wanted a job with purpose, so I decided to transition to Stanford.

For the last 16 years, I’ve worked in blood and marrow transplant with immunocompromised participants. But you realize that for a lot of people it’s just not enough to have standard treatments. We have to continually improve them. There are therapies that have still yet to be discovered — as in the case of COVID-19 a few months back, when there was absolutely no frontline treatment.

TSD: How has COVID-19 impacted your and your team’s research?

SS: In March, my team and I were shell-shocked. When February rolled around and we were starting to realize there is this disease that nobody seemed to know how people get — and there was just so much misinformation. We saw the numbers in New York go from bad to worse in terms of cases and fatalities. Since most of the studies we did were observational at the time, my team came to a standstill for a couple of months. We had to figure out two things: One, we had to comply with the “shelter in place” order; two, we had to determine if our trial fell into the essential category. And the answer was no. But just as quickly, we pivoted because we now had drug companies that realized that drugs such as remdesivir, which was actually developed for Ebola, could potentially be used to ameliorate the effects of COVID-19, and we immediately kicked our efforts into high gear.

These last few months have been the hardest of our lives. We’ve worked incredibly long days — 12 hours a day and seven days a week, depending on the needs of the participants. We have onboarded studies as quickly as possible, just so that we are able to get these life-saving drugs to our participants in a timely manner. It’s critical for us to run different trials that look into other modalities of therapy, to see how we can add another arsenal to combat COVID-19.

And then of course came the vaccine study, which meant pivoting in a slightly different direction and trying to find people who may or may not have had COVID-19, trying to find people in the healthcare field to do this study with the same rigor that we would do with any other study at any other time — but knowing that there is the shadow of COVID-19 hanging over all of us, and the urgency that we need to find something to treat it.

TSD: How are you and your team conducting the COVID-19 vaccine clinical trials?

SS: There are a few COVID-19 vaccine trials at Stanford. The Johnson & Johnson study, which is based on a recombinant vaccine, is currently underway, and the other is the Novovax study.

With the Johnson & Johnson study — the study I am involved in — the goal was to find as many people as we could to carry out this Phase 3, double-blind, placebo-controlled, randomized trial. Thankfully in the Bay Area, we have incredibly altruistic participants, who know that they had a 50% chance of getting the actual vaccine or getting the placebo. We had a tremendous response from the community enrolling in the trial to see if they could help with the discovery of an effective vaccine.

A lot of the outreach on our part was based on making sure that we were enrolling people whose communities have been the hardest hit and enrolling people who are essential workers, including health care workers. And now that we are almost done with enrollment for the trial, our goal is going to be to follow these people for two years and look at the long-term effects of this vaccine.

TSD: What does your typical day at the SCCR look like?

SS: At SCCR, we run a number of trials. We run observational trials and interventional trials. So a typical day would be coming in and managing my team of clinical research coordinators who are getting ready to see participants in our various research studies in the clinic. These are studies that have to do with drugs, vaccines and other biologics — or there are observational studies where we’re looking at people serially and longitudinally over many years to see what their baseline was when they came to us and how it has evolved over a period of time.

A typical day would also be interacting and reaching out to participants, especially underrepresented minorities and those who are in underserved communities, and talking to them about why it would be good for them to take part in a clinical research study. I also interact with participants who are already in studies and the sponsors who run these clinical research studies. Companies come to us and they say, “we have this therapy,” or, “we have this study we would like to carry out.” And one truth is that a lot of my work is also administrative: You have to go through the whole process of budgets and contracts to make sure that all the regulatory competencies are addressed.

TSD: What are some of the concerns you have that communities of color are less likely to get vaccinated? How can these concerns be addressed?

SS: I think for communities of color it’s almost a social perspective. In our study, we’ve encouraged a lot of people of color to take part in these trials. And the reason they have taken part in the trial is not necessarily because they’ll be getting the vaccine, but it is to encourage people in their communities to shy away from the all too real and legitimate fear of, you know, being guinea pigs in an experiment, if you will.

I don’t necessarily think that communities of color, compared to other communities, are any more or any less predisposed to getting vaccinated — I think it has to do with access. It’s almost a social conundrum. How do they get the vaccine? If you are someone who may not have health care, what do you do to get a vaccine that you may or may not be able to afford? What I would encourage everybody to do is to talk to community advocacy and outreach groups for assistance and information.

If you are looking to get herd immunity by vaccinating 70% of the population, that 70% includes everybody, including people who may or may not have health care. I can understand why some people might have hesitation. I myself grew up in India — it’s a country that is rife with a lot of infections, so I think I grew up very comfortable with the idea of receiving life-saving vaccines. Things might be a little bit different here where being vaccinated or choosing to be vaccinated is luxury. And I would just encourage people to talk to their doctors, healthcare providers, family, spiritual leaders, mentors and their communities, and then make an informed decision.

This transcription has been condensed and lightly edited for clarity.

This article has been updated to clarify that people should talk to doctors and healthcare providers as well as community members to make an informed decision about the vaccine. It has also been updated to clarify that Shashidhar encouraged people to talk to community advocacy and outreach groups for assistance and information.

This article has been corrected to reflect that Shashidhar referenced the Novovax study, not the Pneumovax study. The Daily regrets this error.

Contact Ihita Ghosh at ihita.ghosh29 ‘at’ gmail.com.

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