As Variants Emerge, COVID Clinical Trials Need Volunteers

Since the start of the pandemic, medical research on COVID-19 tests, vaccines, and medications has relied on thousands of volunteers participating in clinical trials.

With the emergence of the Omicron variant, the need for volunteers is especially important, Susanna Naggie, MD, the vice dean for clinical research and associate professor of medicine in the Duke University School of Medicine, told Verywell.

The emergence of the new variant reinforces the need for clinical trial participants, according to the National Institute of Allergy and Infectious Diseases.

Pfizer recently announced that they'd tested three doses of the COVID-19 vaccine against the Omicron variant in a laboratory. Patient trials are likely to follow these initial tests. Gritstone Bio, a California biotechnology firm, is about to start clinical trials on an Omicron-specific vaccine in South Africa, which currently has the highest number of cases attributed to the variant.

Naggie is also a clinical trials researcher with a coordinated clinical trial initiative announced by the National Institutes of Health (NIH) last year. The initiative is a public-private partnership intended to prioritize and speed up the development of the most promising treatments and vaccines for COVID-19.

“Actively enrolling [participants in] studies will likely capture new variants and the impact of the variant on efficacy [of vaccines and treatments] can be assessed,” Naggie said. “There is a need [to do studies with] …authorized or approved drugs with these new variants…to insure it…translates to clinical outcomes.”

Why We Need More Clinical Trials

The NIH, as well as drug companies and academic medical centers, have been recruiting volunteers for COVID-19 clinical trials since the pandemic began.

“Over the course of this pandemic, significant progress has been made in treating COVID-19 and helping to save lives,” Francis Collins, MD, PhD, NIH director, told Verywell.

But the work isn't done yet.

“There are many more studies that need to be done,” Aaron Glatt, MD, chair of infectious diseases at Mount Sinai South Nassau Hospital in New York, told Verywell. “Still under consideration is the optimal booster, for example, and switching, as vaccination against COVID-19 continues, from one vaccine to another.”

So, while we already know quite a bit, there are still aspects about the vaccines and treatments we need to learn more about, Glatt said.

“With so many people unvaccinated, key studies include additional medications to treat the virus,” Glatt added.

Kenneth Mahaffey, MD, professor of medicine at the Stanford University School of Medicine, directs staff and faculty conducting dozens of COVID-19 clinical trials. Like Glatt, Mahaffey said a key reason for needing additional clinical trials is lingering vaccine hesitancy.

“We still unfortunately still have a lot of people getting sick from the virus and we need to have drugs that help either prevent disease or mitigate disease symptoms,” Mahaffey told Verywell. These types of treatments are needed for breakthrough infections as well.

So why should you volunteer for a trial? Glatt said there are personal benefits to joining—such as trying new treatments if you have lingering symptoms of COVID-19. And there are also, of course, the benefits to your family and society.

How to Find a Clinical Trial

ClinicalTrials.gov is a U.S. government website that maintains a list of many ongoing clinical trials. If you type COVID-19 in the search box and you’ll find over 7,000 trials in various stages of progress.

If you have or have had COVID-19 you may be asked to join a trial by your doctor or the hospital. Combat Covid organizes trials by specific situations such as adults exposed to COVID-19 who have not contracted the virus.

Clinical Trial Safeguards

Clinical trials can give you access to life-saving vaccines and treatments. For example, thousands of people got the now widely used COVID-19 vaccines months before anyone else was eligible.

Emily A. Largent, JD, PhD, RN, an assistant professor in the department of medical ethics and health policy at the University of Pennsylvania’s Perelman School of Medicine, told Verywell that ethicists hope the protections in place help foster trust.

Before they begin, clinical trials must be approved by an institutional review board (IRB). An IRB is made up of doctors, scientists, and people like you and is dedicated to making sure that study participants are not exposed to unnecessary risks.

Many clinical trials are also closely supervised by a data and safety monitoring board (DSMB). The DSMB is made up of experts on the trial’s targeted condition who periodically look at the results of the study as it is in progress. If the DSMB finds that the experimental treatment is not working or is harming participants, the board will recommend that the trial be stopped right away.

Every clinical researcher is required to monitor participants to make sure they’re safe. These safeguards are an essential part of the research.

These research protections are responses to historical abuses, Largent said, and as a result, we have developed ethical and regulatory guidelines to ensure that trials are conducted with integrity “with the wellbeing of participants front of mind for investigators.”

What to Consider Before Joining

However, new treatments can pose risks and side effects, so you should “ask if it is right for you,” Glatt said. If you have a personal physician, it's a good idea to review the trial information with them.

When you join a clinical trial, you’ll be asked to sign an informed consent form, which will include plenty of details about the specific trial. People who join clinical trials must give informed consent. This means that you'll be told exactly what is going to happen, what the risks are, and what your rights are. But you should also ask any questions you may have before signing up.

You should also ask about any incentives such as travel and childcare costs, as well as the time commitment that will be needed on your part. It’s rare to be paid to be a clinical trial participant, and the Federal Trade Commission (FDC) states that this may be a sign the trial could be fraudulent. Some trials could ask you to call in once a week, while others could ask you to come to a medical center for blood work, which might be far from your home.

“There’s no right answer as to whether you should join a trial,” Glatt said. “It has to be right for you.”

Largent urges people considering trials to consider time commitments and any possible burdens, such as taking time off from work, driving, staying overnight, and then thinking of the individual and societal reasons for participating.

At Stanford’s trial sites, according to Mahaffey, participants are included in the research process so they can understand:

• The science in simple terms
• Why the trial is being conducted
• How they can contribute
• How the individual study they’re involved with could impact the virus at the societal level

“I use a concept called the three 'Es,'” Mahaffey told Verywell. "Engage, educate, and empower. Engage in process, educate about the importance of research, and empower people to be participants in the process, not just research subjects.”  

Mahaffey said that becoming engaged increases the chance that trial participants will stay with the trial until its conclusion, and that’s important. The larger the trial, the stronger the results, so keeping participants enrolled is critical for the value of the data.  

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.