Experimental Health

Volunteers in clinical trials not only help researchers but also allow medicine to advance.
Friday, April 16, 2004 | 12:00 a.m. CDT; updated 5:44 p.m. CDT, Monday, July 21, 2008

A white-coated stranger pricks your finger. A cold stethoscope and the tight cuff of a sphygmomanometer monitor your blood pressure. They poke, they prod and you wait. It’s not for money or for fame. Perhaps it’s for your health, but it’s certainly for the future.

No, you’re not getting your annual checkup, but you are participating in one of the community’s most prevalent forms of research — the clinical trial.

Between University of Missouri Health Care and the Missouri Cancer Associates, hundreds of Columbians are turning their minds and bodies over to scientists and physicians. The trials range from the testing of unregulated asthma drugs and experimental cancer treatments to evaluating widows’ health in their natural environment.

Giving your body to science isn’t the gamble it may appear to be. The clinical trial — a research method that uses human volunteers to answer a specific scientific question — is a heavily regulated and strictly monitored process that is behind most advances in health care.

Every year, new clinical trials analyze treatments or test drugs to find out whether they can safely treat human ailments and diseases more quickly and effectively.

Some trials involve sick patients looking for alternatives to traditional treatment, while others prefer healthy volunteers hoping to contribute information for future sufferers. Either way, this meticulous process is being applied to more than 200 studies across Columbia.

Getting started

Clinical projects test treatments, prevention tactics, diagnostics and even quality of life. But even the most well-written grant or trial proposal needs money to move forward.

Pharmaceutical companies, the National Institutes of Health, voluntary groups and physicians typically sponsor clinical trials. US Oncology, for example, a network of health care providers specializing in cancer treatment and research, sponsors a majority of the 65 trials currently underway at Missouri Cancer Associates.

“Foundations will address whatever concern their foundation has,” said Susan Koenig, director of clinical research for the MU School of Medicine. She said the Juvenile Diabetes Research Foundation is currently sponsoring MU physicians to investigate potentially hereditary diabetic traits.

Once funding is in place, a researcher must gain approval for the study from an Institutional Review Board. All procedures outlining the recruitment of volunteers, any scientific activity done under the supervision of the researchers, all data collection and any potential risks for volunteers must be reviewed and approved by an IRB before experimentation or advertisement can begin.

Different IRBs review different projects. The institutions within MU Health Care, for instance, are regulated by their own Health Sciences IRB. But no matter the area of experimentation or type of sponsorship, the creed is the same for every IRB: to protect the safety and rights of the patients involved in the trial.

According to the Health Sciences IRB Web site, its goal is to “advance research in the community that is fair and ethical according to applicable regulations.”

Maurice Manring, MU Health Care spokesman, said that in addition to the Health Sciences IRB, a number of other agencies also protect the welfare of patients, including the Food and Drug Administration and departments of health at the state or national level.

Attracting research subjects

The type of study determines how much advertising a physician or scientist must initiate to get the necessary volunteers. In all cases, the sponsor covers advertising costs. Some trials rely on referrals from physicians whose patients are likely candidates for certain studies. These trials use little or no public advertisement.

Lisa Schlatter, who coordinates trials at the Breast Cancer Prevention and Early Detection Laboratory, said that its office receives most volunteers from breast-screening centers whose physicians are familiar with its trials.

Manring said MU promotes its trials through the community and in university-sponsored forums. He said the newspaper is the system’s most successful recruiting tactic.

Advertisements change depending on the study, but they are never flashy.

“You’ve seen them; they are plain and simple,” Manring said.

All ads are strictly monitored. “The IRB reviews all of our advertisements to make sure they are neutral and informative,” Koenig said.

The various sizes, types and subjects of the clinical trials in Columbia keep them from being amassed under a single definition.

What they share is an attempt to analyze a variable’s effect on the body in hopes of improving future health care.

Eileen Porter, associate professor in the MU School of Nursing, conducts descriptive research that measures the quality of life of elderly women living alone.

By understanding how elderly women function from day to day, Porter said she hopes to make future nurses more attuned to their needs.

Her new study, about the experience of reaching help quickly, involves home interviews of women over 85 who live alone and need assistance getting out of their homes. From her research, she wants to develop ideas for clinical trials of interventions to help older women reach help quickly and effectively.

Other trials rely on physical evidence to support the research. The Breast Cancer Prevention and Early Detection Laboratory runs trials with both invasive and noninvasive breast procedures as part of its protocol. A protocol is the study’s plan for answering the research question and maximizing patient safety.

Schlatter said one of the lab trials gives cancer-free women a questionnaire focusing on reproductive history, takes a blood sample and samples breast fluid through a noninvasive breast pump.

But before any of that information can be gathered, volunteers at this clinic and others must read and sign an informed-consent form.

This form ensures that the potential volunteer understands the details of the trials and its processes, including any potential risks and benefits.

The forms vary in length depending on the study. Schlatter said that for the cancer-free volunteer study, it was about eight pages.

Many trials encourage potential volunteers to bring a trusted friend or family member to the meeting where they are given the informed-consent form. Lisa Atkins, an oncology-certified nurse and the clinical research coordinator for Missouri Cancer Associates, said she never lets a patient sign the informed consent the first time she meets them.

“I’ve had people change their mind even when they said they would do it at first,” Atkins said.

After the informed consent is signed, testing can begin.

Why risk it?

Informed consents state clearly that testing of unregulated drugs and new treatments can cause unforeseen, as well as documented, side effects and unidentified risks.

But for many sick people, the idea of hope is worth the risk.

“The notion of the clinical trial is more attractive with painful, high mortality-rate illnesses,” Manring said.

Manring said that despite knowing potential risks, people will proceed with clinical trials if there is a perceived advantage over traditional treatment.

Atkins, of Missouri Cancer Associates, said she believes many people are attracted by access to medicine that is not yet approved by the FDA.

She sums up their attitude as, “I don’t have anything to lose anyway.”

But for the healthy, or for those whose treatment works, trial participation is an investment in the future.

Schlatter said the women participating in the lab’s current trials, which utilize diagnosed, at-risk and breast cancer-free women, choose to participate primarily for the possibility of improving breast cancer detection in the future.

“The biggest benefit isn’t to themselves,” Schlatter said, “but for women down the road.”

Does it pay?

Some clinical trials give participants money, but it is considered a reimbursement or stipend — not a coercive tactic.

One of the breast cancer lab’s current studies asked the IRB to allow a stipend for volunteers. It would be a one-time reimbursement of $25 for transportation costs and time off of work.

“(The researcher) never wants the money to be a woman’s reason for taking part in research,” Schlatter said.

Porter said she pays her volunteers in appreciation for their time.

She said some women were happy to get the money, others were nonchalant, and a few did not accept the money after participating.

Both Manring and Atkins said they were not aware of any cases in which their respective organizations paid the volunteers.

But the payoff can come in helping those currently suffering and those who might in the future.

Drugs successfully tested in clinical trials, for example, can become regulated by the FDA and be sold to the public.

After trials at Missouri Cancer Associates, Bevacizumab was approved by the FDA in February for the treatment of advanced colorectal cancer.

“In the past five years I have seen more drugs being approved by the FDA than ever before — and more quickly,” said Atkins, who has been working with clinical trial patients for 17 years.

She said clinical trials involving breast cancer treatments, for instance, have expanded the possibilities to eight options from the original two.

“Without clinical trials,” she said, “you wouldn’t advance in any way.”

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