Our COVID coverage is currently supported by a grant from the United Way of Northern California. Grant funding does not impact Shasta Scout’s editorial independence.

A small clinic on Eureka Way in Redding is one of hundreds of clinical research sites across the United States that provide evidence-based trials for vaccines, medications, and other medical interventions. Clinical trials provide the phased human research needed for pharmaceutical companies to eventually gain approval of individual products, including COVID vaccines, by the Federal Drug Administration, or FDA. 

Locally, Paradigm Research Clinic, Inc., an independent for-profit clinical trial facility, began running clinical trials of the COVID vaccines in August 2020, six months after COVID first appeared in California. Through contracts with Pfizer, Johnson & Johnson, and Moderna, Paradigm facilitated clinical trials that involved around 400 people, says Sarah Sandberg, the research facility’s certified clinical research coordinator and site manager.

Sandberg, a Redding area local who’s worked at the clinic for the last six years, says it’s gratifying that over 90 percent of the clinic’s research participants decide to continue volunteering with Paradigm on an ongoing basis after participating in one clinical trial. She says that’s because many find the work fulfilling as a way to advance science and better the community, but also because the clinic provides financial compensation for the people who choose to participate in the human phase of medical testing.

Long-time Shasta County local Jim Cowee, who is in his eighties, agrees. Cowee, a retired banker, who describes himself as “deeply conservative,” approached Shasta Scout independently about his participation with clinical research trials at Paradigm. He says he connected with the company about ten years ago, through a friend who was already participating in trials. The money was good, he says, one hundred dollars to enter the program and more with continued participation, up to about eight hundred dollars for an entire trial. 

“I liked the idea of doing research and getting paid for it,” Cowee says, estimating he’s personally participated in about five different clinical trials averaging eighteen months each during his time working with Paradigm. “You feel good about contributing to something,” Cowee explained, “and you feel even better for contributing and getting paid for it.”

Money is an important part of incentivizing local volunteers who apply and qualify to take part in clinical trials. The amount they are paid reflects the time they’re asked to invest in the project, Sandberg said, which varies from trial to trial but includes diary entries, safety calls, clinic visits, and lab work. A typical visit or activity would range in payment amount, Cowee said, from five dollars for filling out a short weekly survey to fifty or a hundred dollars for a clinic visit which might include a lab draw. 

Volunteers undergo intense pre-screening to ensure that they’ll qualify for the carefully monitored clinical trials before they’re brought in for clinic visits. Sandberg said the clinic has a large database of possible volunteers, but is always recruiting more, particularly those from diverse age groups and ethnic backgrounds. Many of the Shasta County research participants are senior citizens.

“I like to say that clinical research advances science one clinical trial at a time,” Sandberg said, explaining that some clinical research participants who help Paradigm are also hoping that the medical interventions they may receive as part of the trials could improve treatment for their own medical conditions. For example, in the case of COVID vaccines, research participants were able to access the vaccines months before they received emergency authorization for public use by the FDA in December of 2021. 

That was the case for Cowee, who was vaccinated with both shots of the Pfizer vaccine in September of 2020. At the time, as a feature of the research, neither he nor Paradigm staff knew if he’d received the vaccine or a placebo, and he didn’t find out which he’d received until after the FDA authorized the vaccine for use in his age group. 

He says now his only concern with his participation in the trials was the delay of about a month between when the vaccine was approved for use and when he found out that he had indeed already received it. As someone in a high-risk category due to both age and medical conditions, Cowee wanted to make sure he was protected as soon as possible, one of the reasons he had participated in the trial. Both he and Sandberg said that Pfizer, not Paradigm, made the decision on when to release participant results.

The Pfizer authorization was possible only because of human clinical trials like the ones Paradigm ran locally. The first Emergency Use Authorization for a COVID vaccine was released in December 2020. That authorization was based on safety and effectiveness data from randomized, controlled, blinded ongoing clinical trials of thousands of individuals, including those in Shasta County. 

The clinical trials were part of Operation Warp Speed, launched by the Trump administration to rapidly develop, produce, and distribute COVID vaccines in efforts to protect lives and health during the rapid and unprecedented spread of the COVID virus. So far, COVID is responsible for the deaths of at least one million Americans, including more than 600 in Shasta County.

About 66 percent of Americans are fully vaccinated, although only 54 percent of Shasta County residents have received both doses of any of the vaccines. COVID vaccines are most effective at reducing the risk of serious illness, hospitalization, and death from COVID, but are also significantly effective in reducing an individual’s risk of contracting the virus. 

Sandberg said the COVID vaccines were not the first time Paradigm had conducted clinical trials as part of a warp speed response to a pandemic. In 2016, the clinic conducted human research of ebola vaccines at a similar pace, Sandberg said. In both cases, the clinic employed standard processes to ensure that all human participants met the age, gender, ethnic diversity, and medical history requirements for participation in the research.

Because patients who will receive vaccines or other medical interventions represent a variety of demographics, it’s important that clinical trials do too, she said. That’s one reason why clinical trials occur in smaller groups across a variety of locations in the United States. Here in Redding, Sandberg said, volunteers for clinical research are usually older and white, although the center is always seeking to diversify its volunteer population through new recruiting.

The clinic was founded in 2009 by a local neurosurgeon, Dr. Jamish Saleh. In recent years, two more branches, including one in southern California and one in Colorado, have opened. Paradigm eventually hopes to open fifteen research clinics across the nation, particularly in areas with more ethnic diversity, where diverse individuals can be more easily recruited into trials.

All totalled, Paradigm’s clinical trials for the COVID vaccines included more than 400 participants in a series of trials that included testing of booster vaccines. And although the clinic is no longer enrolling in COVID vaccine trials, they continue to collect data from the patients in their vaccine booster trials to monitor for the presence of viral antibodies as a means of assessing how long the vaccines’ effectiveness lasts. 

That research will help guide FDA recommendations on how often Americans should receive COVID boosters to help keep the pandemic at bay, driving future recommendations from the Centers for Disease Control and Prevention (CDC), and helping to protect populations, particularly the most vulnerable, from the most severe effects of COVID, including death. 

For participants in COVID vaccine research, learning if they had received the vaccine or a placebo became particularly important as the vaccines became available to those around them after emergency authorization came through from the FDA. Most clinical research trials at Paradigm are “observer-blinded,” meaning neither the patient or the research staff know whether they have received the intervention or a placebo.

The clinic is allowed to unblind patients only after the research is complete. For those who had received one of the COVID vaccines, Sandberg said, the reaction to learning their vaccinated status was excitement, followed by concern about how long they might be protected by the vaccines, a question, Sandberg says, they still can’t answer for certain. 

The clinical research trial process includes careful measures to ensure that all adverse reactions are tracked, Sandberg said, and that any reactions are shared with the network of clinical research centers, the FDA, and the vaccine manufacturers. That’s because rapid reporting of adverse reactions can quickly halt research if it appears to be posing a threat to the health of participants. 

Out of the 400 patients Paradigm worked with, Sandberg said, the clinic did not have any serious adverse reactions related to the COVID vaccines. Physical reactions that may be connected to one of the vaccines are always reported to the sponsor, the pharmaceutical company, within 24 hours. This is mandated by FDA and Institutional Research Board (IRB) requirements for clinical research on human subjects, whether or not the physician in charge of the program believes the reaction to be caused by the vaccination.

In the case of adverse reactions, a safety report is sent to all sites testing the vaccine and adjustments may be made in how the vaccine is tested or who is allowed to be included in the trials if there appear to be connections between a patient’s gender, age, or medical history that may correlate with an adverse reaction. 

Notably, clinical trials are funded, or sponsored, by the pharmaceutical companies whose medical intervention is being tested, in what is essentially a fee-for-service model. Sandberg says payment coming from vaccine manufacturers does not represent any kind of conflict of interest for Paradigm because the clinic gets payment regardless of what the data shows. 

The clinic is currently testing vaccines for Respiratory Syncytial Virus (RSV) and Cytomegalovirus (CMV), and will be testing a pneumonia vaccine and a new Pfizer flu vaccine beginning in August, Sandberg said. Beyond vaccines, the center is testing treatments for chronic cough and Chronic Obstructive Pulmonary Disease (COPD) and is looking into trials of treatments for Parkinson’s disease and migraines. Patients have to pass rigorous pre-screening criteria that vary by the clinical trial. They must also sign agreements that ensure their medical costs will be covered should they suffer any adverse reactions from their treatment.

The clinic is currently running nine ongoing trials with around 600 patients.

Disclosure: Jim Cowee is a board member of Shasta Scout.

Annelise Pierce is Shasta Scout’s Editor and Community Reporter covering government accountability, civic engagement, and local religious and political movements. You can contact her at [email protected]