Clinical trials aim to advance medical research, help Utah patients
"You have to weigh the benefits and the risks, and indeed there are risks, but there are also definite benefits, particularly for chronic disease sufferers who are still seeking the treatment that is right for them," he said.
The drug development and approval process spans approximately 15 years, including three phases of clinical trials to test the safety and effectiveness of new medications and procedures. The average cost of developing a new biotechnology drug (new generation of drugs) is $1.2 billion, Trewhitt said. Between 45 percent and 75 percent of the cost is borne by implementation of the trials, which he said could be a boon to the local economy, depending on the number of studies done here.
The influx of money, however welcome it is at a budget-driven university, doesn't change the way trials are conducted.
"There is no amount of money that would make me hurt people to help any company, Pharma, or anybody," Spigarelli said. "Research, as long as it is ethical and needed, aims to make the future better."
He said the U. doesn't aim to make money on its successful trials, but has a goal to help people and improve overall clinical care.
More and more trials are recruiting children, as fairly new legislation made it OK to involve them with parental consent. Spigarelli said it is making a difference because many of the drugs available today, while they are commonly prescribed to children, have yet to be tested in young people.
Pregnant women are another understudied population that researchers are working on.
Ongoing research is helping to update drug labels, as well as redefine dosage instructions, making new and old medications safer for children and adults alike.
"A university's fundamental jobs are to teach people, expand knowledge and create a more educated work force for tomorrow," he said. "Doing clinical research fulfills all of those goals."
Research, Spigarelli said, "distinguishes the truth from myth and lets us move on to what can really help. The benefit to the public is the health care we have today."
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