Step by Step
New discoveries and treatment concepts must clear many hurdles before they become part of patient care. Pre-clinical evaluation is extensive, and clinical testing itself is a methodical process that moves forward in distinct phases.
“In a phase I drug trial, for example, we are trying to determine a number of things, including what dose is tolerated by patients and what its side effects might be,” Dr. Thomas said. Phase I trial groups are small and can include patients with different kinds of cancer.
“In a phase II trial, we treat people with a specific kind of cancer to see how active the drug might be,” Dr. Thomas said. “Here, we want to see if the treatment leads to an improved outcome, like shrinking the tumor.” Phase II trials can involve as few as 30 and as many as 200 patients. Early phase drug trials are usually only available at an academic medical center.
The next step for therapies with a record of safety and effectiveness in early trials is validation in a larger, phase III study. “In phase III, the new therapy is compared to the existing standard of care to see which one is better,” Dr. Thomas said. “These trials often involve thousands of patients, are conducted on a national level and take several years to complete.”
Not all clinical trials focus on new drugs. Trials now under way at the Clinical Cancer Center are examining ways to combine standard drugs, deliver radiation therapy and plan the best treatments. “Some are large national trials spearheaded by cooperative research groups. Others are large investigations sponsored by industry,” Dr. Thomas said. “And some clinical trials are unique to our institution – clinical studies developed by our own faculty.”
For example, a team of medical, surgical and radiation oncologists at the Clinical Cancer Center has developed a phase II clinical trial for patients with pancreatic cancer. The researchers are using genetic analysis to identify the unique molecular characterization of each patient’s tumor. They then use this “genetic fingerprint” to determine which drug therapy patients should receive before surgery.
“This is one of the first instances of using personalized medicine for treating this deadliest of all cancers,” Dr. Thomas said. “It’s an example of doctors from different disciplines working together and using the latest in molecular oncology to try to improve outcomes for patients.”
Gearing Up for Rapid Growth
Research activity at the Clinical Cancer Center has increased in recent years, and it will expand even more in the months ahead. Several moves are now under way to accommodate the growth.
One initiative is the development of a Cancer Translational Research Unit (TRU), a special nursing unit in the Day Hospital devoted to caring for patients in phase I and II trials. (The Day Hospital provides a comfortable outpatient environment for patients needing chemotherapy, blood products or other infused treatments or advanced services that might otherwise require hospitalization. It’s open seven days per week, 365 days per year for patient convenience and quality of care.) “The TRU will be staffed by specially trained research nurses,” Dr. Thomas said. “Nursing is key to a successful early phase trials program. These nurses will provide a high level of monitoring and be very involved as members of the clinical research team.”
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Specialized Oncology Nurses Make a Difference
At Froedtert & The Medical College of Wisconsin, patients count on receiving highly specialized care from an entire team of oncology experts.
Oncology certified nurses are important members of this team, and the hospital was recently honored with the national Oncology Nursing Certification Corporation Employer Recognition Award. The award recognizes Froedtert Hospital’s sustained support of specialty certification in oncology nursing.
“Nursing certification is a key part of Froedtert’s professional practice,” said Julie Griffie, RN, MSN, ACNS-BC, AOCN. Griffie is a clinical nurse specialist and manager of the nursing practice at the Clinical Cancer Center.
“To meet our cancer patients’ complex needs, we encourage nurses in our inpatient oncology areas and the Clinical Cancer Center to become oncology certified, and we support their efforts,” Griffie said. “Having oncology certified nurses on board assures patients that their nurses have the knowledge to provide effective care for the complicated problems associated with a cancer diagnosis.”
Special Report 2012
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