Despite the urgent need for more research into the coronavirus, the New York Times reported on August 14 that there have been numerous testing delays, staffing shortages and space constraints tying up the process.
Despite the urgent need for more research into the coronavirus, the New York Times reported on August 14 that there have been numerous testing delays, staffing shortages and space constraints tying up the process.
Testing, in particular, has been a major hurdle for many biopharmaceutical companies. In outpatient trials being run by Eli Lilly and Regeneron, for instance, rules pertaining to testing have become obstacles. According to the guidance provided for one Regeneron trial, a patient must be treated with antibodies within seven days of the onset of symptoms. In Eli Lilly’s ongoing coronavirus trial, a drug must be given to a subject within three days of taking a positive test. It’s these types of stipulations that have proven problematic for many companies, and researchers, in particular.
The process of gathering data has also proved troublesome for those who are on the hunt for a vaccine. CNN reported on August 16 that the development of a vaccine could be delayed as a result of researchers failing to recruit sufficient numbers of minorities for clinical trials. According to Dr. Jim Kublin, executive director of operations for the COVID-19 Prevention Network, only 10% of the 350,000 people who have registered online for a coronavirus clinical trial are Black or Latino.
The Moderna trial that has been making headlines for entering Phase III in the U.S. received a “C” grade for recruiting minorities from Dr. Francis Collins, director of the National Institutes of Health. Collins told CNN that from the first week he saw the numbers, they were not “as encouraging” as he would have liked.
That being said, other countries around the globe have taken the initiative to recruit more minorities for clinical trials. Reuters reported on August 16 that Britain had begun urging the elderly, along with volunteers from the Black and Asian minority groups, to sign up for a COVID-19 vaccine trial registry. More than 100,000 people have volunteered thus far to take part in vaccine trials, but Britain’s business ministry says that more subjects are necessary to ensure that the future product is fully effective.
In England, a study showed that minority ethnic groups were two to three times more likely to have COVID-19, compared to Caucasians. Additionally, disproportionate numbers of people from minority groups have also died from the disease across the country.
Back in the U.S., data from the Centers for Disease Control and Prevention suggests that Blacks, Hispanics and American Indians are almost three times more likely as whites to contract the novel coronavirus. In addition, they are almost five times as likely to be hospitalized for the disease.
The U.S. Food and Drug Administration (FDA) issued guidance as of late that “strongly encourages” the inclusion of more diverse populations as clinical trials roll on, according to Kaiser Health News. That being said, the FDA does not require biopharmaceutical companies and researchers to meet these goals. Furthermore, it does not have a policy in place that requires it to refuse trial data from groups who do not comply.
Stephaun Wallace, director of external relations for CoVPN, told Kaiser Health News that there are many practical problems that stand in the way of minorities participating in clinical trials. Clinic hours and limited transportation are just some of the issues, and many people simply don’t want to feel like a “guinea pig” being experimented on for a trial.
According to ClinicalTrials.gov, as of August 10, there were 2,935 studies being conducted to further investigate COVID-19.
