Arkansas’ medical school has been able to play matchmaker to more than 1,100 patients for potential clinical trials in the four years since it received a multimillion-dollar federal grant designed to speed up drug development, officials said this week.
Its matchmaking tool: ResearchMatch.org, a national database of research volunteers.
The goal: Ease the difficulty of finding the right patients for medical trials and studies - especially in rural places like Arkansas.
“On average, it takes a successful drug 10 years from the point of discovery to widespread clinical use,” said Dr.Curtis Lowery, founder of the Translational Research Institute at the University of Arkansas for Medical Sciences in Little Rock, adding that 80 percent of drugs fail during clinical trials.
Recruiting the right kind of patients as study subjects - and enough of them - is one of the reasons it takes so long.
“I grew up in rural Alabama,” said Lowery, also director of UAMS’ Center for Distance Health and chairman of its obstetrics-gynecology department. “If you’re in a rural area, right now you have virtually no chance of participating in these trials.”
Finding people can even be difficult in large, metropolitan areas for the trials.
“If it’s a rare disease, for instance, they can get patients - but it might take them 10 years to do it,” Lowery said.
More common diseases can also be challenging in the urban areas.
“Cancer trials usually require big, large, patient recruitment, and often across multiple medical schools across the country,” he said. “Some of the women’s breast cancer treatment trials have struggled to recruit patients.”
The five-year, $19.9 million grant funded in part by the National Institutes of Health will end March 31, 2014.
UAMS announced on Monday that it had reached the 1,000 mark for the registry. Nationally, there are about 35,000 volunteers. Thenumber of Arkansans in the ResearchMatch registry had grown to 1,111 by Thursday, Robinson said.
Medical studies, particularly clinical trials, are crucial in testing whether a new drug, vaccine, therapy, medical device or blood product will work safely and effectively in humans before it is made widely available.
For the patient, clinical trials are not without risk, Lowery noted. There’s the possibility of side effects, and no guarantee the patient won’t be taking a placebo rather than the study drug without knowing it.
The appeal to a patient could range from helping contribute to a growing body of science to finding a successful treatment or cure for their disease.
A second reason clinical trials and studies can take so long, Lowery said, is that following necessary federal regulations to ensure the human test subjects’ best interests are protected can itself take a long time. The work of local Institutional Review Boards must happen before a trial’s first patient is even recruited.
Among UAMS’ partners on the initiative is the National Center for Toxicological Research in Pine Bluff, Lowery said.
“We’re working to train regulatory scientists down there,” he said.
Lowery noted that the always-diff icult task ofrecruiting study participants was further hindered by the federal patient privacy law, the Health Insurance Portability and Accountability Act of 1996.
“I can’t cold-call people with disease characteristics - it’s a HIPAA violation,” Lowery said. That’s because he can’t use a patient database file to screen for such specifics.
Andrew James, a researcher at the Brain Imaging Center in UAMS’ Psychiatric Research Institute who works with the registry, said there is a workaround. He can use search parameters to instruct a computer e-mail program to e-mail the relevant people in the database.
“At no point do we get to mine their information, or see their addresses or phone numbers,” James said, and then the volunteers can respond only if they’re interested in a particular study.
He still uses conventional advertising such as newspaper and bus ads, but said the registry is interactive and “enduring,” since the database can be reused and updated .-
Northwest Arkansas, Pages 7 on 05/31/2013