Finding a cure for Alzheimer’s, diabetes or the flu may not be a feasible goal for the average person, but taking a step in that direction is doable. At least that’s the way Bridget Davidson sees it.
Every time she participates in a lab study, this resident of San Diego, California, feels she’s helping scientists narrow down drugs and treatments for those afflicted with disease.
“They need to find a cure for diseases and need to find healthy people to try the meds out on. I’m a healthy female, so why not try it,” said Davidson.
People already faced with a disease often participate in clinical trials, too.
Altruistic reasons are often cited as a motivation for participating in cancer clinical trials, said researcher Lora Black.
“We often hear, ‘This may not benefit me but it may benefit the next generation,’” said Black, director of operations for oncology clinical research at Sanford Health in Sioux Falls, South Dakota, whose subjects have already been diagnosed with cancer. Keep in mind that “every medicine we use today had to go through a clinical trial,” she added.
Most adults with cancer, however, are hesitant to join clinical trials.
A recent study done by the Fred Hutchinson Cancer Research Center and the University of Washington found that nearly 1 in 4 publicly sponsored cancer clinical trials fail to enroll enough participants to draw valid conclusions about treatments or techniques.
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Low participation rates are true across the board, which is why the Institutes of Medicine issued a recent directive to “improve selection, support, and completion of publicly funded cancer clinical trials,” according to the Journal of the National Cancer Institute.
What exactly is a clinical trial?
“A clinical trial is a scientific research study in which patients help doctors find ways to improve standard treatments and a patients’ quality of life,” Black told LifeZette. “Carefully conducted research studies are the fastest and safest way to find new treatments and improve the health of all patients. Simply stated: Today’s gold standard of care was yesterday’s research study.”
Davidson, 50, has taken part in more than a dozen studies, including research for pain relievers, diabetes and cancer. However, the study she participated in recently for Alzheimer’s had a personal component.
“My aunt died of Alzheimer’s a few weeks ago,” she told LifeZette.
The idea of being a guinea pig isn’t new to Davidson. She was a medic in the Army and learned how to do procedures on fellow recruits. “We practiced on each other.”
Volunteering for drug testing fits in with her history of aiding others in life-altering ways.
“About 20 years ago, I was a surrogate mother. I think doing the clinical study is the same kind of thing. It is just the next step. I feel like I’m helping somebody.”
But what about the potential side effects?
In a startling report noted last month in the New York Times, six people were hospitalized and one declared brain-dead after a phase 1 drug trial in France.
Deaths or serious adverse reactions during phase 1 clinical trials are rare. Last year, the British Medical Journal found serious adverse events in only 0.31 percent of participants and no deaths when testing non-cancer phase 1 drugs, according to the article.
Still, isn’t she concerned? Sure. But Davidson carefully reads the sections detailing the side effects before signing the consent form and ultimately trusts the drug companies, comforting herself saying “it goes through a lot of phases before it gets to phase 1 in clinical trials.”
“It is a little bit of a risk, but I like that part of it,” added Davidson. “It’s as safe as it can be.”
Research subjects are protected in a variety of ways, explained Black. An ethics board looks at the risks and benefits of the drug and has to approve it before it’s given to a participant. Eleven key items have to be satisfied before the drug is administered.
“It’s like an outside person is looking over your shoulder,” Black told LifeZette. Additionally there is a data, safety and monitoring board. “They can shut down a study if it’s not safe.”
Each subject has to provide an informed consent, which details the risks and benefits. Federal regulations include the alternatives to treatment, the cost to the patient and what would happen if they were injured. Furthermore, a person can quit at any time.
As for the unfortunate outcome in France, Black, the researcher, explained that each country has its own set of rules and guidelines to follow.
On the positive end of the spectrum, there are some perks to being a lab rat, said Davidson, who participates in studies when she can work it around her full-time job.
“I really love the people you meet in studies.” They support and encourage each other, often sharing contacts for other clinical trials, she said. “I’ve made some long-term friends.”
It’s also been a good source of income.
At one time, Davidson earned up to $5,000 for 14 days. The more procedures and lab tests a participant goes through, the more money that is earned, she said.
“One time I had to be in bed for four nights and had IVs in both arms.” The clinic supplied meals, TV, Wi-Fi, books, movies, games and around-the-clock monitoring.
Maria Gray, 38, prefers dermatological studies and says she’s on the winning side when it comes to the research.
“I have forehead lines and they were doing a Botox study,” said Gray, of Miami Beach, Florida. “It was a year-long study. I went once every two weeks. I’d go to the clinic and have blood tests that would take about two hours. At the end of the study, I got paid $850 that included travel time plus research.”
The bonus was “they gave me the product also.” Based on how much the treatment would have cost in her doctor’s office, she was way ahead. “It came out that I earned almost $2,000.”
So far, Gray has participated in four trials and she’s hoping to do another study, this time on crow’s feet. Dermatology studies are lucrative, she said. “You’re getting an expensive product you don’t have to pay for.”
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Plus, “when you get Botox in the doctor’s office, it’s diluted. But in the study it’s pure product. It lasted so much longer than when I paid for it,” she told LifeZette.
Being a lab rat isn’t for everyone, acknowledged Davidson. A flexible schedule is essential. Also, “you have to be a certain kind of person,” someone who is open to the unknown and willing to put up with mild to moderate discomfort. Still, the fear factor can be off-putting.
Some studies require blood draws every 15 minutes, and that alone separates out a lot of participants. “Some people cringe at the thought of it,” Davidson said.
The money and free products notwithstanding, participating in clinical studies is for the greater good of mankind, said Black. “Without the volunteers, we can’t accelerate the science.”