The COVID vaccines brought to mind something many Americans don’t normally consider: the importance of clinical trials. More and more, clinical trials are being rightly recognized as crucial components to bettering human health. The medicines and treatments we depend on go through rigorous trials to ensure safety and efficacy. However, the pandemic has fundamentally changed how clinical trials are conducted, with exciting results.
“Now more than ever, people need to hear about clinical trials,” says Dr. Christina Brennan, MD, MBA, and vice president of clinical research at Northwell Health's Feinstein Institutes for Medical Research. “Without clinical trials, we wouldn’t have effective COVID vaccines. And without volunteers for those trials, we wouldn’t have the EUA (emergency use authorization) that allows us use of the vaccines.”
It’s understandable that we’d focus on the outcome of those trials given that we’re still in the midst of a pandemic. But the volunteers—42,000 in the case of Pfizer, 30,000 in the case of Moderna—are just as important. According to Dr. Brennan, not only were these volunteers willing to pay it forward for the greater good, but their willingness to participate led to the FDA granting the vaccines EUA, thus allowing us to safeguard millions of people against the worse outcomes of COVID-19.
By conducting the trial virtually, the Feinstein Institutes removed a huge barrier to entry. Trials of the future, which Dr. Brennan notes will most likely use a hybrid model of both virtual interactions and in-person study, will be able to maintain this more equitable approach.
The second game-changing effect of a virtual trial is that it exponentially boosts recruitment.
“People don’t want to keep coming back and forth to a hospital, even when there isn’t a pandemic,” says Dr. Brennan. “A decentralized trial boosts recruitment and gives us a far more diverse demographic of participants that more accurately reflects the population Northwell serves.”
More diverse, more equitable, and now with the available tech to make them possible, virtual trials are catching the attention of pharmaceutical companies nationwide. Northwell’s model, which emerged from the very depths of the worst pandemic in over 100 years, looks to be the new gold standard, and is one of many lessons learned chronicled in Michael Dowling’s recent book, Leading Through a Pandemic, which offers a full accounting and retrospective of the challenges Northwell faced and how to face the challenges of future pandemics.
Still, Americans have an inchoate distrust of clinical trials. It’s the final barrier that researchers like Brennan are hoping that a renewed awareness of the importance of clinical trials will overcome.
“Trusting clinical trials begins with trusting your doctor,” says Dr. Brennan. “Your doctor should be presenting you with all your options, including the possibility of participating in a clinical trial where applicable.”
Participation in clinical trials has benefits, notes Dr. Brennan. Often, participants in clinical trials receive extra care, a bit of “TLC” over and above the already high standard of care Northwell provides. Plus, participants get the satisfaction of paying it forward to future generations.
“Participants in today’s clinical trials are tomorrow’s medical heroes,” says Dr. Brennan. She recalls that we just celebrated the 100-year anniversary of the drug insulin. “Insulin started as a clinical trial made up of volunteers. Without those volunteers, we wouldn’t have the life-saving drugs we have today. We have them to thank.”
Giving volunteers the ability to participate from home was a group effort. Along with new Bluetooth technology that tracks a participant’s vitals, as well as an extension of Northwell’s existing home lab test kit program, plus partnerships with sponsors that helped provide necessary items like iPads, researchers interacted with trial participants through the mail. This at-home, virtual model had two game-changing effects for the future of clinical trials.
“Part of the issue with the way clinical trials were conducted in the past was that, because you had to go to a hospital, clinic, or research facility, it excluded certain demographics,” says Dr. Brennan. “People who lack access to reliable transportation or who are working two jobs to make ends meet often don't have the time or resources to participate in these trials.”
The future of clinical trials is bright, especially as its participants become more representative of the population as a whole. Dr. Brennan and the researchers at Feinstein Institutes are doing their part. Will you do yours?
To learn more about clinical trials offered by Northwell Health through the Feinstein Institutes for Medical Research, please visit this site.
However, at the moment, there are significantly more vaccines than there are FDA-approved treatments for COVID (there’s currently just one, Remdesivir). Northwell’s Feinstein Institutes is working towards filling that gap and is reimagining how clinical trials can be conducted in the process. Its clinical trial for the drug famotidine, a common antacid, first made waves when it was announced in April of last year, with Northwell CEO Michael Dowling saying he had “a reasonable confidence” that famotidine would make a difference in the treatment of COVID patients.
Over a year later, we know a lot more about how the trials were conducted. And while we don’t yet have published results, professionals like Dr. Brennan remain hopeful on famotidine’s potential use for COVID treatment. The famotidine trial came about out of necessity and then the logistical conditions of a pandemic caused researchers to make revolutionary changes to traditional clinical trials.
“Because Northwell was at the epicenter of the first surge in March of 2020, and then again in the second surge, we knew we wanted to focus our research on therapeutic trials rather than preventative ones,” says Dr. Brennan. Famotidine, known more commonly by its brand name, Pepcid, offered researchers looking to find treatments quickly an elegant solution. “We don’t yet have a Tamiflu for COVID, which is why we were focusing our efforts on repurposing readily available drugs.”
For the first trial, each volunteer was already admitted to the hospital for COVID-19 and received their clinical dose of famotidine via an IV there. There were immediate challenges to this approach.
“With the way the COVID surges waxed and waned, it was difficult to get people to participate,” recalls Dr. Brennan.
In the end, famotidine trial 1.0 enrolled 233 people. Dr. Brennan and the other researchers were encouraged, but knew they needed to expand the next phase to more people. But how could they do so in the middle of a pandemic? The last thing researchers wanted was to ask COVID-positive patients to come to their lab while they were recovering from COVID.
“Trial 2.0 transitioned to outpatient,” says Dr. Brennan. “Instead of an IV, we used a pill. Instead of in-person observation, we used a questionnaire. This allowed people to participate in the trial from the comfort of their own homes.” This decentralized virtual trial became the first of its kind.
Clinical Trials
How the Pandemic Changed the Way Clinical Trials Are Conducted and Why It Matters
"Now more than ever, people need to hear about clinical trials...Without clinical trials we wouldn’t have effective COVID vaccines."
"Participants in today’s clinical trials are tomorrow’s medical heroes...Insulin started as a clinical trial made up of volunteers. Without those volunteers, we wouldn’t have the life-saving drugs we have today. We have them to thank."
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“This is not just about guns, this is a serious public health issue, and we have to start looking at it that way.”
Dr. Christina Brennan
The COVID vaccines brought to mind something many Americans don’t normally consider: the importance of clinical trials. More and more, clinical trials are being rightly recognized as crucial components to bettering human health. The medicines and treatments we depend on go through rigorous trials to ensure safety and efficacy. However, the pandemic has fundamentally changed how clinical trials are conducted, with exciting results.
“Now more than ever, people need to hear about clinical trials,” says Dr. Christina Brennan, MD, MBA, and vice president of clinical research at Northwell Health's Feinstein Institutes for Medical Research. “Without clinical trials, we wouldn’t have effective COVID vaccines. And without volunteers for those trials, we wouldn’t have the EUA (emergency use authorization) that allows us use of the vaccines.”
It’s understandable that we’d focus on the outcome of those trials given that we’re still in the midst of a pandemic. But the volunteers—42,000 in the case of Pfizer, 30,000 in the case of Moderna—are just as important. According to Dr. Brennan, not only were these volunteers willing to pay it forward for the greater good, but their willingness to participate led to the FDA granting the vaccines EUA, thus allowing us to safeguard millions of people against the worse outcomes of COVID-19.
By conducting the trial virtually, the Feinstein Institutes removed a huge barrier to entry. Trials of the future, which Dr. Brennan notes will most likely use a hybrid model of both virtual interactions and in-person study, will be able to maintain this more equitable approach.
The second game-changing effect of a virtual trial is that it exponentially boosts recruitment.
“People don’t want to keep coming back and forth to a hospital, even when there isn’t a pandemic,” says Dr. Brennan. “A decentralized trial boosts recruitment and gives us a far more diverse demographic of participants that more accurately reflects the population Northwell serves.”
More diverse, more equitable, and now with the available tech to make them possible, virtual trials are catching the attention of pharmaceutical companies nationwide. Northwell’s model, which emerged from the very depths of the worst pandemic in over 100 years, looks to be the new gold standard, and is one of many lessons learned chronicled in Michael Dowling’s recent book, Leading Through a Pandemic, which offers a full accounting and retrospective of the challenges Northwell faced and how to face the challenges of future pandemics.
Still, Americans have an inchoate distrust of clinical trials. It’s the final barrier that researchers like Brennan are hoping that a renewed awareness of the importance of clinical trials will overcome.
“Trusting clinical trials begins with trusting your doctor,” says Dr. Brennan. “Your doctor should be presenting you with all your options, including the possibility of participating in a clinical trial where applicable.”
Participation in clinical trials has benefits, notes Dr. Brennan. Often, participants in clinical trials receive extra care, a bit of “TLC” over and above the already high standard of care Northwell provides. Plus, participants get the satisfaction of paying it forward to future generations.
“Participants in today’s clinical trials are tomorrow’s medical heroes,” says Dr. Brennan. She recalls that we just celebrated the 100-year anniversary of the drug insulin. “Insulin started as a clinical trial made up of volunteers. Without those volunteers, we wouldn’t have the life-saving drugs we have today. We have them to thank.”
Giving volunteers the ability to participate from home was a group effort. Along with new Bluetooth technology that tracks a participant’s vitals, as well as an extension of Northwell’s existing home lab test kit program, plus partnerships with sponsors that helped provide necessary items like iPads, researchers interacted with trial participants through the mail. This at-home, virtual model had two game-changing effects for the future of clinical trials.
“Part of the issue with the way clinical trials were conducted in the past was that, because you had to go to a hospital, clinic, or research facility, it excluded certain demographics,” says Dr. Brennan. “People who lack access to reliable transportation or who are working two jobs to make ends meet often don't have the time or resources to participate in these trials.”
The future of clinical trials is bright, especially as its participants become more representative of the population as a whole. Dr. Brennan and the researchers at Feinstein Institutes are doing their part. Will you do yours?
To learn more about clinical trials offered by Northwell Health through the Feinstein Institutes for Medical Research, please visit this site.
However, at the moment, there are significantly more vaccines than there are FDA-approved treatments for COVID (there’s currently just one, Remdesivir). Northwell’s Feinstein Institutes is working towards filling that gap and is reimagining how clinical trials can be conducted in the process. Its clinical trial for the drug famotidine, a common antacid, first made waves when it was announced in April of last year, with Northwell CEO Michael Dowling saying he had “a reasonable confidence” that famotidine would make a difference in the treatment of COVID patients.
Over a year later, we know a lot more about how the trials were conducted. And while we don’t yet have published results, professionals like Dr. Brennan remain hopeful on famotidine’s potential use for COVID treatment. The famotidine trial came about out of necessity and then the logistical conditions of a pandemic caused researchers to make revolutionary changes to traditional clinical trials.
“Because Northwell was at the epicenter of the first surge in March of 2020, and then again in the second surge, we knew we wanted to focus our research on therapeutic trials rather than preventative ones,” says Dr. Brennan. Famotidine, known more commonly by its brand name, Pepcid, offered researchers looking to find treatments quickly an elegant solution. “We don’t yet have a Tamiflu for COVID, which is why we were focusing our efforts on repurposing readily available drugs.”
For the first trial, each volunteer was already admitted to the hospital for COVID-19 and received their clinical dose of famotidine via an IV there. There were immediate challenges to this approach.
“With the way the COVID surges waxed and waned, it was difficult to get people to participate,” recalls Dr. Brennan.
In the end, famotidine trial 1.0 enrolled 233 people. Dr. Brennan and the other researchers were encouraged, but knew they needed to expand the next phase to more people. But how could they do so in the middle of a pandemic? The last thing researchers wanted was to ask COVID-positive patients to come to their lab while they were recovering from COVID.
“Trial 2.0 transitioned to outpatient,” says Dr. Brennan. “Instead of an IV, we used a pill. Instead of in-person observation, we used a questionnaire. This allowed people to participate in the trial from the comfort of their own homes.” This decentralized virtual trial became the first of its kind.