A Chance to Make a DifferenceWhen Bonnie Reuter of Franklin need a kidney transplant, she opted to participate in a clinical trial to potentially help herself and others.
Bonnie was diagnosed with renal failure about 10 years ago. By 2006, her condition had progressed to the stage that she needed a kidney transplant. The first decision Bonnie had to make was where to have the surgery. After investigating her options, she chose Froedtert & The Medical College of Wisconsin.
Here, Bonnie’s care team presented her with a second decision. Instead of receiving the standard anti-rejection medication, Bonnie was asked if she would like to take part in a clinical trial for an experimental drug. She was interested immediately, partly because she was concerned about the side effects of the standard medication, and partly because she knew it was a chance to help other transplant patients.
She researched the new drug, talked to physicians and then decided to volunteer for the study. “I was excited about the chance to take part,” she said. “You have to weigh the odds and you can’t go into it blindly, but I feel strongly that people need to be pioneers in this kind of thing.”
No SubstituteA clinical trial is a carefully designed test of a new drug, device or therapy, conducted with actual patients. According to Theodore Kotchen, MD, associate dean for clinical research at The Medical College of Wisconsin, clinical trials are critical for getting scientific discoveries out of the laboratory and into general patient care.
“Before a therapy can be accepted, it has to prove its value through a clinical trial,” he said. “There is no substitute. You can’t get from the lab to patients without a clinical trial.”
Researchers at Froedtert & The Medical College of Wisconsin are involved in hundreds of clinical trials every year. Most are large cooperative studies that take place at multiple institutions across the country.
“The strength of our program is its diversity,” said David Gutterman, MD, senior associate dean for research. “We cover a lot of areas, from cardiovascular disease and cancer to neurosciences, diabetes and many other conditions.”
While the science is impressive, the focus of the program is patient safety. “We get quite a few calls from pharmaceutical companies about studying new drugs,” said Sundaram Hariharan, MD, Medical College of Wisconsin nephrologist and interim director of Solid Organ Transplantation. “As a clinician and an investigator, I am very careful about this. I will only accept a drug trial if I feel it will be helpful to patients.”
Dr. Hariharan, who supervises Bonnie’s care, helped her understand the positives and the negatives of participating in the drug trial. Medical College of Wisconsin nephrologist Barbara Bresnahan, MD, is the principal investigator for the study at Froedtert & The Medical College.
“My care team explained all the potential good things about the experimental drug and also what they considered might be the possible side effects and problems,” Bonnie said.
While researchers believed the trial drug could prove to be more “kidney friendly,” Bonnie knew all the side effects might not be discovered until years down the road. She had to consider some practical issues as well. While standard anti-rejection medications can be taken in pill form, the experimental drug had to be infused intravenously. Participating in the study would also mean a good deal of additional follow-up testing. “Being in the trial meant spending about six to eight hours a month at the hospital, versus about one hour a month if you are on the standard medication,” she said.
Even more of a concern to Bonnie was the fact that study participants were required to undergo a kidney biopsy. “Transplant patients generally don’t have to have a biopsy,” she said. “I was concerned because it was a bit of a risk.”
Through the entire process, Bonnie felt at ease about making her decision. “No one pressures you,” she said. “You can ask all the questions you want, and they answer honestly.”
Absolute Rights“The freedom to make an informed choice is one of the cornerstones of clinical research,” said David Clark, PhD, assistant dean for clinical research at The Medical College of Wisconsin. “Patients have an absolute right to know if any part of their care involves experimental therapies. And they have an absolute right to be given a choice about whether or not to participate in a research study.”
According to Dr. Clark, clinical research in the United States is governed by strict federal rules that provide patients with several layers of protection. One layer is independent review. All clinical trials must first be approved by an institutional review board (IRB) composed of medical experts and members of the community who are not involved in the study.
At Froedtert & The Medical College, six separate IRBs review research proposals. Their main job is to fully assess the benefits and risks of an experimental therapy and ensure that the risk/ benefit ratio is favorable to patients.
The IRBs frequently require investigators to revise study proposals. “Researchers cannot do any part of a study until the IRB has reviewed the plan, had all questions answered and decided the study was safe for patients,” Dr. Clark said.
Significant PotentialBonnie’s transplant surgery took place in November 2006. The procedure went well, and she was ready to go home in just three days. Soon after, she began making monthly visits to Froedtert & The Medical College to receive the study drug.
Bonnie said her experience in the trial has been very good. She has not shown any sign of kidney rejection, and she no longer needs blood pressure medication. Her blood creatinine level (a marker for kidney dysfunction) has been very low, a good sign that Bonnie attributes to the experimental drug.
While many patients experience benefits from participation in a clinical trial, there is no assurance that a trial therapy will turn out to be better than standard care.
“With a trial therapy, there is significant potential for improved care; otherwise we would not be studying it,” said Tom Aufderheide, MD, Medical College of Wisconsin emergency physician. “However, an improved outcome is not guaranteed; every research project comes with potential risks. Patients in a clinical trial are followed extremely closely and the risks are monitored carefully.”
Unique ResourcesAt Froedtert & The Medical College, careful patient monitoring and clinical trial support are provided by the Adult Translational Research Unit (TRU).
The Adult TRU is an innovative outpatient clinic specially designed to facilitate clinical trials. It includes several specialized research labs with access to a full range of support services. “This unit is a comprehensive clinic staffed by certified research nurses,” Dr. Aufderheide said. “It can implement virtually any clinical research protocol.”
Nurse manager Katie Klink, RN, MSN, CNL, said working in the TRU is an exciting opportunity for a nurse. “We implement research protocols that make a big difference in terms of better outcomes for patient populations.”
The Adult TRU is an important component of a large research alliance called the Clinical and Translational Science Institute (CTSI) of Southeastern Wisconsin. The CTSI is a unique partnership of the region’s key players in healthcare innovation. In addition to Froedtert & The Medical College, it includes Children’s Hospital of Wisconsin, the VA Medical Center, the Blood Research Institute, Marquette University, the University of Wisconsin — Milwaukee and the Milwaukee School of Engineering.
Through funding and other forms of support, the CTSI encourages investigators from different disciplines to come together to work on health issues. “This institute is unique,” said Reza Shaker, MD, director of the CTSI and senior associate dean for Clinical and Translational Research. “It allows researchers who have been operating independently to connect more efficiently to develop better treatments. Ultimately, that will lead to better health for our citizens.”
The Courage Of GenerosityToday, more than three years after her transplant, Bonnie Reuter said she feels wonderful. She still works every day and has plenty of energy left to cheer on her daughter, Kim, a member of the Alverno College volleyball team.
Volleyball means a lot to Bonnie and her family. She and her husband, Joseph, met on the court, and for years they coached their daughter as a player. Kim is now working toward her nursing degree. “That’s partly due to the medical problems I encountered,” Bonnie said. “She wants to make a difference.”
Bonnie hopes her decision to take part in a clinical trial will make a big difference for others. “From my point of view, we have to learn about new things,” she said. “We need volunteers to come forward and be willing to take part.”
Clinical research coordinator Pat Lyman, RD, CRC, said this attitude makes it a privilege to work with patients in clinical trials. “They are wonderful folks to work with and a courageous group, because they are really journeying into something that is not fully known.”
Lyman is struck by the generosity of Bonnie and people like her. “When you are involved in clinical trials, you learn there is a kind of person who just gives back in life.”
Source: Froedtert Today
Date: January 2010