When it comes to clinical trials, the Kansas-Missouri region “is one of the richest research areas in the U.S., if not the world,” according to a research official with the University of Kansas School of Medicine-Wichita.
“I come from the Houston area, which has a lot of clinical research, but I never saw advertising for clinical trials on TV at 6 o’clock in the mornings like I do here,” said Michele Mariscalco, who became associate dean of research at the University of Kansas School of Medicine-Wichita in late 2010 after being at Texas Children’s Hospital and Baylor College of Medicine.
She speculates that it’s the combination of a large health care industry and compassionate Midwesterners that makes the area prime ground for clinical research.
The Wichita Community Clinical Oncology Program, for example, has consistently had one of the highest clinical trial participation rates among the 63 community cancer programs funded by the National Cancer Institute nationwide, according to Keisha Humphries, a registered nurse who manages the local program. The Wichita cancer program, based at Via Christi Hospital on St. Francis, currently has 122 active trials in cancer drugs and prevention.
The goal of the National Cancer Institute’s Community Clinical Oncology Program is to make sure patients can be treated for cancer close to home while still having access to the latest research.
In Wichita alone, one can participate in trials for a wide array of diseases – from life-threatening conditions such as cancer to chronic conditions such as migraines. Trials can range from small studies that are testing a new drug to larger, later-stage trials that test a drug’s long-term benefits.
All of that testing is important, say medical and research experts.
Procedures such as stenting for weak or narrow arteries or understanding the long-term effects of estrogen, for example, were made possible because of clinical trials, said KU’s Mariscalco.
And understanding when and why a drug or treatment doesn’t work is just as important as knowing when it does, said Raymond Perez, director of the University of Kansas Clinical Research Center in Kansas City.
When Janie Krull, clinical research manager with Via Christi, visits with potential subjects, some tell her they want to participate to help their children or grandchildren with a treatment or cure for a hereditary disease.
“You not only help yourself, but you help everybody who comes after you,” Perez said.
Some patients participate because they’ve run out of treatment options, experts said.
Not every study is for a disease, according to the National Institutes of Health. Some studies might require healthy participants.
Whatever the reason, there are two things subjects should expect, said Mariscalco: that they understand what the trial is about and that they will get the best health care possible.
Trials have to stick to strict sets of protocol and usually involve batteries of tests to track how a subject does. That means patients’ conditions are constantly monitored, at no financial cost to the subjects, said experts. Some trials may reimburse subjects for time and travel expenses.
Some of the Wichita community cancer trials, for example, require that a subject’s tissue samples be sent to another research facility for a second opinion, Humphries said.
Some trials at Heartland Research Associates, a local independent research organization, include DNA testing, noted Cindy Thome, Heartland’s clinical research director. Genetic marker testing can sometimes help determine if a patient will respond to certain treatments, she said.
Subjects get more education about their conditions, more time with a doctor and more “one-on-one” care in a clinical trial, Thome said.
They may also have access to treatment that the FDA has not yet approved for widespread use.
“If they get a treatment and it’s effective, they have an opportunity to get it sooner,” Perez said.
Different types of trials
The FDA’s drug review process consists primarily of four clinical trial phases, experts said. It occasionally requires a fifth phase for more information on a drug’s long-term effects and safety.
Phase I trials usually involve a small subject pool, because it is the first step in new drug testing in humans. Researchers are trying to determine the effective dosage, the drug’s safety and how it works in the body. Testing is more frequent.
Larger groups can participate in phase II trials, which are conducted to see if a drug is effective and to further evaluate safety.
In phase III, another large group study, researchers are confirming the effectiveness of a drug, monitoring side effects and comparing it to other known forms of treatment.
Phase IV trials are studies done after a drug is on the market. They may involve gathering information on side effects on long-term use or testing the drug for another condition other than what it was developed for.
Based on medical staff expertise, some research facilities excel at different conditions.
Perez noted that KU’s Clinical Research Center in Kansas City has strong programs in cancer and Alzheimer’s disease. It has nearly 200 active trials related to cancer alone, he said, but does research into several other conditions, too.
Wichita-based Heartland Research Associates, for example, usually conducts phase II and III studies involving vaccines or treatments for such chronic conditions as an overactive bladder, high blood pressure, cholesterol and other issues. On average, it has 200 active studies each year, Thome said.
With its Comprehensive Epilepsy Center, Via Christi conducts several local and national studies on brain cooling during epilepsy surgery and new epilepsy drugs.
Via Christi researchers said they have about 60 trials in various stages, from actively enrolling to evaluating whether to participate.
How to join a trial
There are two main ways to find out about trials:• Ask your physician. Most doctors are aware of clinical trials, both locally and nationally. They can even contact research organizations on your behalf, said Via Christi’s director of research, Michael Good.
• Go online. Research organizations such as the University of Kansas School of Medicine-Wichita and Heartland Research Associates list current trials on their websites.
For a more comprehensive listing, experts suggest going to either www.clinicaltrials.gov, operated by the National Institutes of Health, or www.centerwatch.com, another clinical trial listing service.
While some sites do a good job of describing trials in general terms, some may use medical jargon.
Don’t let that daunt you, Perez said. “If you go to a website and you find the (medical) language confusing, talk to your doctor,” he said.
You will usually first talk to a coordinator about participating in a study, to help determine if you’re a suitable candidate.
“It’s like dating,” Mariscalco said.
If you’re eligible for a study and you agree to participate, always get a copy of the informed consent form that you will be asked to sign, she said.