Interest in medical drug trials increases among area patients

Outside the medical community, not many people realize Springfield is a hot-bed of medical research. Hundreds of area patients are involved each year in medical trials conducted by St. John's Health System, Cox Health Systems, and Cancer Research for the Ozarks.

"We keep doing more and more studies each year," said Mark Hecker, coordinator of Cox's pharmacotherapy research division. Lately much of the focus has been on hypertension, diabetes, neurology and infectious diseases, he said.

"The studies we do are multi-centered trials, so we're one of many sites doing the study. Our data is pooled together with the other sites' (data)," Hecker said.

St. John's Medical Research Group al-so participates in multi-center trials, said Director Stan Greene. "We're undergoing a pretty substantial expansion right now," he said. "The number of protocols is increasing, and interest is growing."

Considered a multi-specialty research facility because it does both chronic and acute care research, St. John's research division differs from most sites in the nation because of its self-contained staff dedicated solely to research, said Greene.

Research has a number of benefits, Greene said. Physicians are able to ac-cess drugs earlier than they could otherwise, and many physicians enjoy the academic component of participating in re-search.

Local patients also benefit from earlier access to investigational medications, Hecker added.

"The study visits and procedures, as well as the medication, are provided at no cost to the pa-tients," he said.

Both Cox pharmacotherapy and St. John's participate in phase two, three and four trials.

"Ninety percent of our studies are phase three studies," said Hecker. Testing for new drugs begins with tests on animals, he said.

This is followed by as many as four phases of studies involving human subjects.

In the first phase, the drugs are tested on healthy volunteers, Hecker said. "Phase two is the first phase involving patients with an illness." The third phase, which occurs prior to approval from the Food and Drug Administration, is de-signed to determine the safety and efficacy of the medication, he said, adding that sometimes there are multiple phase two and three studies for one drug.

Phase two testing involves fairly small numbers of patients, Greene said, while phase three trials involve large pools of patients. Phase two and three trials typically enroll pa-tients who have a particular disease or condition, but not a lot of other medical complications. "These are fairly healthy patients with a disease state," he said. "That's one of the challenges of interpreting data from clinical trials and applying it to the general population."

Phase four testing, which occurs after FDA approval, is done in more of a "real world" rather than a clinical environment, Hecker said, because the variables aren't as controlled.

The phase four trials are used to investigate a variety of issues, Greene said. "You're studying some other aspect safety surveillance, testing a new dosage form. Most often in the phase four studies we see, the company is simply trying to gather data for new indications."

When a new protocol is initiated by a sponsor, Greene said, an internal review is conducted to determine if it is medically appropriate. "First and foremost is the issue of medical appropriateness," he said. "We don't do anything that's outside the realm of acceptable medicine." Medical research is heavily regulated by the federal government, he added. "It's something we take very seriously."

In the United States, all medical re-search involving human subjects must be submitted to an institutional review board, said Marilyn Bauer, chair of St. John's Health System's IRB. "Our purpose is to protect human subjects and make sure they're fully informed about what they're getting into," she said. "Any research done at St. John's system must go through our IRB." Each research project has to be reviewed by the committee to make sure it is safe, and that participants will be given full knowledge of any possible side effects.

"They make sure there's no undue risk and that everything's done ethically," Hecker said. "They also make sure that people know the risks and procedures in-volved, know their rights, and know who to contact if they have questions."

The review process involves examining every form of advertising that will be used, the informed consent forms pa-tients will sign, and all the published research work on that drug, he said.

Once a trial is approved, the board's job is not over. Patients' conditions are followed, some for a specified time period, and others until death.

"Right now we have about 150 open clinical trials for oncology, " Bauer said.

The IRBs from Cox and St. John's also review cancer studies carried out by of Cancer Research for the Ozarks, a joint program of Cox and St. John's health systems.

"We're a community clinical oncology program, or CCOP," said Lisa Hadley, administrative director. CRO, one of about 60 CCOPs across the country, is partially funded by the National Cancer Institute.

There are 15 different research bases in the United States, five of which provide protocols to CRO, Hadley said. All of CRO's findings are sent to one of these research bases, where the results are compiled with others from around the country.

Cancer Research for the Ozarks has 115 open protocols and almost 500 pa-tients receiving treatment, Hadley said. In all, more than 2,000 patients have been involved in testing. "We're following close to 1,200 patients in the Ozarks," she said, adding that once treatment is finished, patients are monitored for side effects and recurrence.

Cancer Research for the Ozarks, which generally runs phase two or phase three trials and participates in both treatment protocols and prevention protocols, Had-ley said.

Treatment protocols have very strict eligibility criteria, she said, and some protocols call for patients who have been previously treated, while others require that no previous treatment has been done. Some are designed specifically for patients who have tried all options without success.

Testing sometimes is done with FDA-approved drugs, with the use of a new treatment instead of a standard mode of treatment, or by comparing two treatments, she said.

Two of the biggest prevention protocols are STAR, the study of Tamoxifen and Raloxifene, a breast cancer prevention protocol, and SELECT, a similar prostate cancer prevention trial involving Selenium and vitamin E, Hadley said.

Nurses and oncologists are able to foster awareness about treatment protocols among their patients, but recruiting for prevention protocols is more difficult, she said."We've started working with our two mammography centers for us to be able to reach post-menopausal women and give the information about STAR," she said. "We'll also be at a lot of health fairs this year."