Clinic runs trials for new medications
What parent hasn’t stumbled to the medicine cabinet in the middle of the night to grab some cough syrup for a sick child? Even bleary-eyed, sleep-deprived parents have confidence that the medicine will help their child sleep and get well sooner because clinical research backs up that drug’s efficacy and safety.
That research is taking place right here in Georgetown. Since 2000, San Gabriel Clinical Research has worked to ensure the safety of trial medications and vaccines. Certified research coordinator and nurse Sandra VonGerichten, and administrative specialist Kathy Greer work alongside about ten physicians to collect volunteers’ physical data and samples. These are sent to laboratories that determine whether trial drugs work.
Without volunteers, however, research trials wouldn’t be possible. “Volunteers get satisfaction from helping advance medicine,” says Dr. Greg Willis, co-owner and principal investigator for research.
People of all ages and from all walks of life participate in trials that can last from two weeks up to seven years, he says.
“It’s very rewarding,” says eighty-five-year-old Allen Rogers, who began participating more than three years ago, after his doctor suggested a trial might treat a health condition. “They’re very efficient and have my best interests at heart.”
The clinic has five ongoing trials, though it can manage up to fifteen. Participants are compensated for time and travel costs, amounting to between forty and seventy dollars a visit. These last from thirty minutes to a couple of hours and usually involve a blood sample.
The overall process of developing and testing a drug, however, isn’t simple or quick. Medications are developed over five stages, explains Sandra. Preclinical studies involve test tube- or animal-based experiments. During the first phase, a drug is introduced to the human population. The clinic specializes in phases two through four, during which volunteers’ physical data and samples are collected at the clinic and sent to laboratories that determine whether trial drugs are producing the desired effects. Then, if the drug is determined successful and safe, it is approved by the U.S. Food and Drug Administration and released to pharmacies for sale. This process can take up to ten years, says Dr. Willis, because of FDA rules that ensure safety.
Successful trials at the clinic have developed treatments for cholesterol, hypertension, and migraines.
“I’m still alive,” Allen says. “I think that’s the real test. I feel the clinic has been looking after me.”
San Gabriel Clinical Research
SGC Research website