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U.S. Needs Better Clinical Trials, Vaccination Campaigns

Lessons learned for the next pandemic include clinical trials that examine vulnerable groups like pregnant women and minorities and a better information campaign about the efficacy and safety of vaccinations.

Small vials of a COVID-19 vaccine.
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As the nation continues battling the pandemic, health care officials should heed some of the lessons learned thus far, namely that clinical trials should include groups most affected by the pandemic and that accurate information about vaccines needs to win over disinformation.

Those were the key messages during a press briefing by the Infectious Diseases Society of America this week.

“During the last year and a half, we saw that the scientific and health care communities came together rapidly and supplied much-needed evidence on COVID treatments in a timely manner,” said Adarsh Bhimraj, head of the Neurologic Infectious Diseases Section at the Cleveland Clinic.

“But there were shortcomings in the treatment trials that limited the usefulness of the guidelines that could be provided to the public,” he added.

A paper, co-authored by Bhimraj, outlines those shortcomings and provides the guidelines for health care professionals and public officials to follow to facilitate a better response to the next pandemic.

One of the key areas relates to shortcomings in trials, where individuals most at risk to COVID-19 infections were underutilized. Bhimraj emphasized that future trials must be more inclusive of people who are disproportionately impacted.

That includes pregnant women and children.

“We know that enrollment in clinical trials should reflect the population that’s most affected by the disease,” said Rajesh Gandhi, professor of medicine at Harvard Medical School. “We also know that historically certain populations have been underrepresented in clinical trials, often racial and ethnic minorities and the poor.”

He said just a tiny number of people with compromised immune systems — and thus vulnerable to the disease — were included in the trials. Moreover, pregnant women and children have had scant representation.

“Many of our treatment trials have had little or no enrollment of pregnant women, and even though children are less likely to get severely ill, it’s incredibly important to know how to treat children," Gandhi said. "Do the antibodies we use for adults work as well for children?”

Going forward, systems and infrastructure need to be developed to reach those populations and get the necessary participation from them in clinical trials.

The nation also needs to come to grips with how to disseminate information to the public about the safety and efficacy of vaccines.

Gandhi said the rush to get the vaccines available has led to reservations about their safety. Even so, the techniques used to develop the vaccines are proven, and COVID vaccines work similarly to the vaccines that people have been getting for decades.

The vaccine itself doesn’t stay in the body long but instead triggers the immune system to fight off the disease.

“I do think [disinformation] is one of the biggest challenges,” Gandhi said. “Unless people get reliable information, they’re making decisions based on the wrong information essentially. That’s where trusted messengers, people they’ve known prior to COVID can really make a difference and that’s sometimes their health care provider or someone in the community.”
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