“Clinical studies evaluate the safety and effectiveness of investigational treatments, devices and vaccines to help prevent and treat diseases,” explained Kasie Ingram, the marketing and recruiting coordinator for Coastal Carolina Research Center, a locally-owned medical research facility in North Charleston. “Before a drug is placed on the market, it first has to go through a set number of clinical trials to gather enough data to be approved by the Food and Drug Administration as safe and effective.”
Clinical studies have been around for a long time. The first recorded one dates back to Babylon in 562 B.C. It seems King Nebuchadnezzar ordered his courtiers to consume only meat and wine to achieve the best physical health. Captive Hebrew men protested, requesting a vegetarian diet with water instead. The trial lasted only 10 days, and the vegetarians were clearly the winners.
Fast forward to 1757, and we have James Lind conducting a scurvy trial that included some basic control elements. In 1946, streptomycin became the subject of the first randomized control trial complete with detailed design, organization and data collection. Since then, clinical studies have continued to become more ethical, sophisticated and, of course, regulated. In the last 20 years, the number of clinical studies has skyrocketed. Today, more than 400,000 individual trials are being conducted around the world.
Clinical studies are separated into several phases that must be completed before any new drug, device or treatment can be submitted to the FDA for licensing and approval. Exceptions occasionally are made – with some COVID-19 vaccines and treatments, for example. In these cases, limited approval may be given for emergency usage only, with full approval granted at a later date.
A significant number of volunteers is mandatory for clinical trials. To encourage enrollment, research companies offer monetary payments based on the particular phase of the study and specific requirements for its participants. Ingram is proud to report that Coastal Carolina Research Center has employed more than 25,000 Lowcountry volunteers for various studies. Typical payments are between $200 and $3,500.
Is money alone reason enough to become a clinical study volunteer? It was for Nancy Schaefer when she completed her first trial study in 2014. However, eight studies later, she’s more concerned about the opportunity to make a difference by helping others. She is not alone. Contributing to the advancement of science and taking an active role in society is personally rewarding for many volunteers, while others sign on because their own health or medical issues may benefit in the process.
Schaefer has one other important reason for continuing to enroll in clinical studies: the staff at Coastal Carolina Research Center.
“They are all so nice to me – the doctors, the nurses and the staff. I have been there so many times that I know them all, and we are almost like family,” she stated.
In fact, Schaefer is so well-known and valued by the research center that they call her when a new study comes up for which she might be a good fit. If her daughter-in-law, a pharmacist, approves the safety and requirements of the study, Schaefer is ready to sign the paperwork and get started.
Coastal Carolina Research Center competes with other similar research organizations for cutting-edge studies.
“We were the first in the country to screen/vaccinate a patient for the Epstein Barr virus with the mono prevention vaccine,” said Ingram. “Currently, we are doing a clinical study involving two mRNA vaccines created by Moderna that are being evaluated for their safety and effectiveness against the cytomegalovirus and Epstein Barr virus. Both diseases are closely related to viruses that cause chickenpox, mononucleosis and other medical conditions.”
The Center also does research trials for more general health issues such as smoking, weight loss, OCD, diabetes, depression and migraines. Funding comes from pharmaceutical or biotech companies.
Coastal Carolina Research Center is always looking for new volunteers. To learn more about participating in one of the many clinical studies listed on its website, visit coastalcarolinaresearch.com or contact the center at [email protected] or 843-856-3784.
By Janet E Perrigo