Ask an Expert: How the Front Lines are the Impact of COVID-19 on Clinical Trials

Ask an Expert: How the Front Lines are the Impact of COVID-19 on Clinical Trials

Around the globe, hospitals and medical staff are grappling with the massive challenge presented by the COVID-19 pandemic. Tackling COVID-19 is potentially the most important medical research issue of our generation, but it’s also creating a myriad of research challenges that we’ve never had to wrestle with as an industry. In addition, COVID-19 is bringing hundreds of important clinical trials to a halt, affecting critical research in every area of medicine.

Clinical research teams everywhere are dealing with how to respond to these difficulties and continue their life-saving research in a rapidly changing new normal. I had the honor last week of sitting down (virtually, of course) with Dr. Christina Brennan, MD, MBA, vice president of clinical research at Northwell Health’s Feinstein Institutes for Medical Research in Manhasset, New York. Dr. Brennan has more than 20 years of extensive clinical research experience, including more than 16 years in clinical management roles. Dr. Brennan is currently on the Board of Trustees of the Association of Clinical Research Professionals (ACRP) and is also the immediate past president of the New York Chapter of ACRP.

Dr. Brennan has been on the front lines of the COVID-19 pandemic in New York, helping one of the premier research institutions cope with the massive wave of novel coronavirus cases while also being one of the first sites in the United States to spin up COVID-19 clinical trials. Her experience provides critical insight into the challenges and choices facing hospitals as they manage this crisis and think about the world beyond it.

Right now: Come together to move quickly

Our conversation comes on the heels of the crest of the pandemic wave in New York. Thousands of patients poured into hospitals in a matter of weeks and hospitals had to respond at warp speed. The first priority was safety – of COVID patients, hospital staff, and non-COVID patients getting treatment at the facilities. The organization quickly had to decide what to do with their ongoing clinical trials.

“We knew that we wouldn’t really be able to conduct clinical trials in the way that they should be.” – Dr. Christina Brennan, MD, MBA

As a result, the senior leadership put a majority of trials on enrollment hold. But they decided to keep some trials open, such as life-saving oncology trials with ongoing treatments, to continue providing continuity of care.

To manage concerns from principal investigators (PIs), they worked with their local IRB and created a process for PIs that wanted to continue their trials.

“We put together a guidance document that basically said, if you still feel that your trial should remain open during this pandemic, please provide a rationale, and it must meet the following criteria.” – Dr. Christina Brennan, MD, MBA

Most trials were successfully put on hold and non-essential staff transitioned to working remotely.

Then, the hospital was approached to run their first COVID clinical trial. The team was able to cut through all the red tape, negotiate contacts, determine budgets, and get central IRB approval to spin up the trial in four days. This included bringing back some of the research staff that has been working remotely to support the labor-intensive, FDA-regulated trial.

At first, some staff had concerns about returning to the hospital in the midst of the pandemic.

“So I was getting concerned about how I was going to be able to really pull the trial off. But once one or two came in it created a little bit of momentum where people wanted to come into the hospital and they said, ‘This is what it’s about. This is what healthcare is about. This is what I signed up for.’ So then we really started to have a steady stream of folks who were in the hospital with us, on the front lines side by side with the physicians on the COVID unit.” – Dr. Christina Brennan, MD, MBA

It took a herculean effort on all sides to pull it off.

“Everyone came together and this included those on the sponsor side. There were no weekends anymore. Everybody was working around the clock. I’ve been doing this for 20 years. I’ve never enrolled 216 patients in one trial in 18 days. It was insane. You didn’t sleep.” – Dr. Christina Brennan, MD, MBA

Moving forward: Look at what changes you can keep

The team had to adapt in real-time to conduct research and provide medical care during the crisis. That gave them both the opportunity and the push to implement new processes and technology that hadn’t been used widely before.

“We were able to do things that we’ve been scratching our head about as an industry for so long. When we would say to ourselves, ‘What does research look like in five years? In 2030?’ Well, I think we were doing a lot of those things. Things we said that we would like to do in the future.” – Dr. Christina Brennan, MD, MBA

The team quickly shifted to telemedicine so doctors could continue meeting with patients. In labor and delivery the staff adopted video calling so partners could take part in ultrasounds from the parking lot while they weren’t allowed to accompany their pregnant partners to their appointments. Research staff implemented remote monitoring to continue important work on clinical trials.

Informed consent for COVID patients proved to be particularly tricky due to strict precautions to prevent the spread of the virus and the rapid advancement of the disease. The team discussed different ideas, including using iPads, but nothing solved the scale and scope of the logistical problems. Finally, the team was able to develop a system that allowed them to consent patients quickly, while maintaining safety and respecting the heart-wrenching situations many patients and they families were in during those key moments.

“We figured out a process, in conjunction with our infectious disease physicians, of being able to consent those who were alert and oriented with paper consent. Then after the patient consented, there was one investigator consenting in the room, and we had the door slightly ajar so someone could witness from outside the room. Because that’s one thing you really have to be careful of is to protect the staff from exposure outside the room. Then the consent form would come outside of the room and immediately placed in a biohazard bag, which would then be placed in a clean Ziploc bag. So, we figured it out. And we figured it out without excluding the patients who were intubated.” – Dr. Christina Brennan, MD, MBA

Dr. Brennan’s team has been able to use what they’ve learned to help other departments and sites implement effective informed consent processes more quickly.

“Now we’ve been teaching other departments who have started trials after us. Currently we have over 500 patients on trials.” – Dr. Christina Brennan, MD, MBA

With the initial wave of the pandemic receding, all of these process improvements provide an opportunity for hospitals to evaluate their old and new processes, and keep some of the changes. While things like telemedicine and remote monitoring may have been originally implemented to manage the reality of life during crisis, they could provide long term value to clinical trial operations.

Dr. Brennan also suggests hospitals consider creating a version of their standard operating procedures (SOPs) for crisis situations, to both document their lessons learned and be prepared for future pandemics without having to reinvent the wheel.

Looking to the future: Be prepared for the world not to go back to normal

As the industry looks at the long-term impact of COVID on clinical trials, Dr. Brennan warns that things are unlikely to return to business as usual.

“The environment is going to be very different here and across the nation. We’ve always talked about how recruiting was one of the biggest challenges, how only 11% of trials really reach recruitment without having to double timelines and do all these other drastic measures to get the trial done. With trials being voluntary, patients are not going to so easily want to enroll in something that is not really part of their standard care. We’re finding that already.” – Dr. Christina Brennan, MD, MBA

If researchers previously relied on patients coming in the door as their primary recruitment strategy, now is the time to start reevaluating those approaches to prepare for a much different environment moving forward.

With patients nervous about volunteering for trials, Dr. Brennan believes research teams will need to modify their processes to make their trials more patient-centric. This could involve using telemedicine and remote monitoring to decrease visits to medical facilities. This could also involve having staff visit patients at home for blood draws or having medicine delivered to the patient’s home.

Final thoughts for researchers on the front lines

The biggest challenge, Dr. Brennan says, was having to balance research with clinical care while bearing the emotional toll of not being able to help every patient during the crisis.

“I think when you’re in the middle of a crisis or a pandemic, it’s very easy to lose your focus on clinical trials and think of science over medicine. We found ourselves wearing our heart on our sleeves and so desperately wanting to help every patient. You can forget that you are doing these double-blind randomized trials, and you wanted the treatment to work for every patient. So to me, those are my hardest days — not knowing the treatment assignment for the patient, wanting to help every patient and knowing that we were doing the scientific rigor that was necessary. And we might not necessarily help the patient today, but we’re helping the patients of tomorrow. I had to keep bringing that back into focus for myself.” – Dr. Christina Brennan, MD, MBA

I cannot thank Dr. Brennan enough for sharing her experience and lessons learned with the rest of us during this exceptional time for our industry and our society. We’ll be releasing additional installments of this series in the coming weeks as experts share how their organizations and the entire clinical trials industry is responding to COVID-19. Join our newsletter to hear about them as soon as they’re published. If there is a question you’d like answered in our series or you’d like to be featured in a future installment, please email me. Stay well.