Hoff's trial is one of nearly 12,000 being conducted in the United States. The subjects cover almost everything in the body from head to toe and involve prevention of illnesses as well as serious and chronic conditions.
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"My main motivation was to get well, but also if I can contribute something in a small way to help people in the future, that would be wonderful."
Clinical Trials Offer Hope to Patients Willing to Take the Risks.
September 6, 2006
By Judy Fortin
CNN
ATLANTA, Georgia (CNN) -- Taking part in a clinical trial is like being on a team, and Charlie Hoff almost didn't make the cut.
At 61, he suffers from congestive heart failure, and heart disease runs in his family. Hoff has had three heart attacks, open heart surgery and numerous other medical procedures. Doctors told him that he might need a heart transplant.
"I was, for all intents and purposes, disabled," said Hoff, a former TV journalist and CNN executive whose health forced him to re-think his professional future.
Climbing stairs left him short of breath. Playing golf or even tossing a ball outside with his two sons, ages 12 and 9, was out of the question.
He was running out of hope when he read a magazine article about a Phase One clinical trial in which a patient's own cells are used to rejuvenate heart tissue. Hoff scoured the Internet and discovered that St. Joseph's Hospital, 15 minutes from his suburban Atlanta home, was one of five research locations.
Less than four weeks after making initial contact with the doctors, he was on a hospital exam table being tested. The morning he met with the research team he felt like a human guinea pig.
"We did test after test after test, tests I had never done before," said Hoff, who by that time considered himself a veteran patient. On the last go-round, his doctor told him something wasn't right. An image on an echocardiogram couldn't be identified. If it was a blood clot or blockage, Hoff was out of the trial.
"Pardon the pun," he said, "but my heart sank." He was "scared out of his mind" when doctors had him swallow a probe to get a better look at his heart. When he awoke from the procedure he saw doctors literally giving him the thumbs up that everything was OK and he was accepted. "It was a great moment. I felt a great sense of relief."
Hoff's trial is one of nearly 12,000 being conducted in the United States. The subjects cover almost everything in the body from head to toe and involve prevention of illnesses as well as serious and chronic conditions. For instance, there are more than 5,000 trials related to cancer and more than 1,600 involving the heart.
A Phase One trial involves a small group of participants who test the drug or procedure's safety, possible side effects and proper application or dosage. Initial participants receive the actual treatment, whereas participants in Phase Two and Three trials might receive a placebo.
The risks are spelled out very clearly to the patients who volunteer for a trial. Every patient must sign a consent form. A patient is allowed to change his mind and leave a study at any time. The National Institutes of Health states "there may be unpleasant, serious or even life threatening side effects...the experimental treatment may not be effective for the participant."
Those were risks Hoff was willing to take. He said, "What did I have to lose?" Besides, he had lost his health insurance last fall and was faced with the prospect of paying for his medical care out of pocket. In a clinical trial, the costs of research and patient care are covered. In some cases, patients are compensated for travel expenses.
For Hoff, it wasn't just about the money, it was about getting better. "If I hadn't done anything, my prospects for recovery would worsen." He's become a self-proclaimed evangelist since the procedure, speaking to research doctors about his experience and giving them a patient's perspective.
He encourages other potential patients to do their homework, know what they are getting into and go for it. His illness is a "one-way road" and he wanted to move forward. He's optimistic the procedure has allowed him to do that.
Six months after the procedure, Hoff is smiling as he undergoes more testing. His doctors are still trying to determine how well the procedure worked. Hoff has noticed a difference. Not only does he feel better, he said, but he's able to do more. He still suffers from some shortness of breath, but he said he's getting closer to his goal of playing golf and taking a hike with his kids.
He's optimistic about his own outlook and hopes he has made a greater contribution: "My main motivation was to get well, but also if I can contribute something in a small way to help people in the future, that would be wonderful."
Judy Fortin is a medical correspondent for CNN.