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At a time when some Americans are concerned about the safety of a COVID-19 vaccine, tens of thousands have already volunteered to help create it.
As of Monday, more than 138,600 people had signed up to participate in the tests.
“That is why we are optimistic that we will be able to register the trials in an expeditious manner. I think we can do what we have to do, “said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.
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The milestone was reached just a week after the National Institutes of Health launched a network of clinical trials for vaccines and other prevention tools to combat the pandemic.
More is still needed, but the initial increase will go a long way toward meeting the requirement of at least 30,000 volunteers each for the four companies planning to launch Phase 3 clinical trials of their potential vaccines in early fall.
Together, the Moderna, Pfizer BioNTech, AstraZeneca and Inovio trials will require at least 120,000 volunteers.
“I would say it’s very encouraging at this stage,” said Barry Bloom, an immunologist and vaccine expert who is a professor of public health at the Harvard Chan School of Public Health.
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Hundreds of clinical trials for drugs, medical devices, and vaccines are being conducted across the United States at any time, but most are relatively small. Putting together four big tests at the same time, and there are even more planned to go online later in the fall and winter, is a daunting task.
It requires not only volunteers, but also a strong complement of clinics, hospitals and medical centers across the country with staff and doctors experienced in conducting clinical trials.
To make that happen, the NIH launched the COVID-19 Prevention Trials Network, merging four existing clinical trial networks. It launched on July 8 with a website where volunteers can sign up.
The network builds on decades of work creating clinical trial networks that date back to the AIDS epidemic in the late 1980s, Fauci said.
“It would literally take years to build a network that I have built in the last 30 years. So why do it? We are going to use what we have, ”he said.
The people chosen to participate will be racially, ethnically and geographically diverse. In its guide to companies testing possible vaccines, the Food and Drug Administration says it wants vaccine candidates to be tested in populations most affected by COVID-19, including ethnic and racial minorities, pregnant women, the elderly. and people with underlying medical conditions that COVID-19 may worsen.
While the effort comes together quickly, the process follows the same strict protocols that are required of all vaccine developers.
“The guidelines for these trials are really clear. They will be scientifically rigorous and there are no shortcuts, “said Bloom.
Phase 3 clinical trials occur only after months of other tests that start first in cells and then go to animals. Only if everything goes well with animal testing does the process pass to humans.
In phase 1 trials, the goal is to determine any immediate adverse effects. This is done through testing on a small number of healthy people, usually less than 100. For example, for the Phase 1 trial of the Modern vaccine candidate, 45 people participated.
Phase 2 trials extend safety tests and analyze dosage: how high can a dose be administered before there are adverse effects? Usually, several dose levels are tested. Furthermore, these trials seek to see if the vaccine causes an immune response in the subject. They may end up including hundreds of people and expand to include older themes.
Phase 3 trials begin when it is clear that the vaccine does not cause immediate adverse effects and appears to elicit an immune response. The goal is to see if the vaccine really protects subjects against COVID-19 or, if they succeed, makes the disease less severe.
These will be great tests.
“Each vaccine needs to be tested on about 30,000 volunteers,” said Dr. Francis Collins, director of the NIH, in June. “We don’t think we have enough analysis power to be able to document how the vaccine works unless it gets to about that number.”
Half of the participants will receive the candidate vaccine, the other half will receive a placebo.
“A lot of people drop out right there. They say, ‘No, I don’t want it if I don’t get the vaccine,’ “said Dr. Robert Hiatt, professor of epidemiology at the University of California-San Francisco, who has conducted multiple large clinical trials.
Part of the job of clinical trial workers is to overcome such doubts. People in the control group, those who don’t really get the vaccine, are vital to understanding if the real vaccine works, Hiatt said.
“Without them you cannot proceed,” he said.
The researchers ensure that participants understand what they are registering for. First there is an initial admission interview, which can be done over the phone or online. The elect must go through a comprehensive consent process.
The informed consent agreement can last 50 to 100 pages, said Dr. Mohamud Daya, professor of emergency medicine at the Oregon Health and Science University in Portland, Oregon, who runs a large network of clinical trials studying drugs. for emergency conditions like brain injuries. , strokes and heart attacks.
“The average consent form takes between 30 and 60 minutes,” Daya said. “You need to spend time with people, give them time to explain things to them, and ask questions.”
Participants can be asked not only for their medical records, but also for the names, addresses and phone number of the volunteer’s friends, family and neighbors, as well as information about their social media accounts. The information gathered on friends and family helps researchers find participants if they lose sight of them, to ask them if they still want to participate, Hiatt said.
Trials of the COVID-19 vaccine will not last for months, but years, as researchers look at long-term side effects, so keeping in touch is crucial.
“There are all kinds of people who drop out. They lose interest. They move, they get a new cell phone, ”said Hiatt.
While it is unethical to pay volunteers large sums of money to participate in clinical trials, volunteers can expect to receive compensation for their time and effort. It is unknown what other tests will offer, but the Modern Phase 1 test, which launched in March, offered participants $ 100 for each in-person visit they completed. Those who attended the 11 planned visits over a 14-month period could receive a total of $ 1,100.
The actual cost is the medical staff that recruits, interviews, and tracks all participants. It usually costs several hundred dollars per participant in staff time alone. For a clinical trial with 30,000 people, it’s more than $ 6 million. Each person who abandons means that another must be added.
Conducting a large clinical trial is complex and finding the right mix of volunteers is often challenging and can take months, but Hiatt believes that the COVID-19 trials will be different.
“The altruistic aspect of this is attractive,” he said. “People want to be part of the cure.”
This article originally appeared on USA TODAY: We will need large numbers of Americans to test COVID-19 vaccines; 138,600 have been registered ‘very encouraging’
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