Hands On at the Threshold of Medical Science
Translating a brilliant idea into an effective FDA-approved treatment takes years of science, clinical trials and meticulous work. Along the way, many whose names may never appear on the published study make essential contributions to moving advances forward. This very much includes research nurses who perform the hands-on work in clinical trials.
In addition to administering trial drugs and monitoring the condition of participants, research nurses collect the samples and data that FDA and medical decisions will be based on for years to come.
When students enter nursing school, research nursing may not be the first area of specialization that comes to mind. However, like many new nursing specialties, this field is expanding the definition of what nurses can be.
"The studies we are working with are so innovative and cutting edge," UAB research nurse Jennifer Thornton, RN said. "It's exciting to give drugs that have never been given before, knowing they might not only help the patients in the trial, but that the work we are doing today could also help thousands in the future."
Jolene Lewis, MSN RN
A part of UAB's Center for Clinical and Translational Science, the Clinical Research Unit is funded by a Clinical Translation Science Award through the NIH. Nurse Manager Jolene Lewis, MSN RN, and her team of skilled research nurses work in one of UAB's busiest hubs of clinical research.
"More than 100 studies are currently underway and we are preparing to launch several new trials, including some that could be groundbreaking," Lewis said. "In the past, UAB's research nurses have contributed to clinical trials of new medications including the cancer drug Avastin. Some of our more recent studies have included viral vectors against brain tumors, experimental treatments for ovarian cancer, and the first medication trial against Rhett syndrome. We will soon begin our first study using an endotoxin to look at inflammatory response."
That study is one of a number being conducted by principle investigator Jarred Younger, PhD, director of the UAB .
"Our lab has several ongoing studies in fibromyalgia, Gulf War syndrome and arthritis," Younger said. "And in upcoming studies, we will look at autoimmunity in rheumatoid arthritis and MS, and the potential for using an antitussive agent against chronic fatigue and fibromyalgia.
"We investigators rely on research nurses to carry out the hands-on work of clinical trials. There is no way I or my team could do more than a fraction of what they do. As PhD researchers, we are not medically trained to identify a health emergency and deal with it. Recently, one of our nurses was doing a routine blood pressure check of a volunteer and detected hypertension so severe he was in imminent danger of a stroke. She may have saved his life.
"Research nurses need to be good with people. We need them to establish a rapport with participants. Our studies can last a year or more. To get volunteers to keep coming back, it helps if the people in direct contact with them are people they like. If they don't feel comfortable and they drop out, we lose all their data and all the funding we've invested in them.
"Research nurses also need to be very good at what they do. For one of our fibromyalgia studies, patients have to come in for a blood draw every day for almost a month. If the nurses weren't good with needles, it would be hard to keep patients coming back and their arms would look like an accident victim's. I've seen participants at the end of the study who didn't have a mark visible anywhere."
Karen Timmerman, RN-BC
Karen Timmerman, RN-BC became a research nurse eight years ago, building on her extensive experience in the ER, high acuity post surgical nursing, and rural health, where her low income patients often had little access to care beyond what she could bring them on her nursing rounds. She feels her experience in each of these areas has contributed to making her a better research nurse.
"Our work is very detailed," Timmerman said. "If the protocol calls for collecting blood specimens every 30 minutes, it means exactly 30 minutes - not 29 or 31 minutes. After infusion of an investigational drug, each specimen is used to specifically measure pharmacokinetics and pharmacodynamics.
"We also work with healthy volunteers to gather baseline data to compare with what is happening in specific diseases. One study uses nutrition to slow angiogenesis in ovarian cancer. Other trials are helping us learn more about Alzheimer's, diabetes, Huntington's, and a broad range of autoimmune disorders so we can better target new treatments. One of the most unusual studies I worked with involved going into operating rooms during C-sections. I gathered samples for a study to help determine the best ways to use antibiotics to prevent post surgical infections."
Fellow research nurse Thornton says one of the most interesting studies she has done was for glioblastomas. "Patients had four catheters surgically implanted and we administered the trial drug to all four locations simultaneously," she said. "We have recently been working with pain studies and a trial of an existing drug to determine whether it might also be helpful in major depressive disorder. These patients often have multiple mental disorders. We are gathering data on how they respond so researchers can determine whether it could help patients overcome a severe depressive episode and which patients would be good candidates for the therapy."
Doing such specialized and detailed work takes preparation. Before each study begins, Nurse Manager Lewis reviews the protocol and sets up in-service training for the nurses who will be working with participants.
"We meet with the nursing coordinator for the study and often the principle investigator to go over the specifics," Lewis said. "They tell us about the drug and how it is thought to work, any known potential side effects, and the exact requirements for the protocol. The researchers explain what they are trying to accomplish and the whys behind the science. Then we go through procedures step by step. Nurses ask any questions they have until we are sure everyone is on the same page.
"Good clinical research data begins with recruiting good research nurses. I look for people who are good at focusing on details and who understand why we need to be so precise. Experience as a nurse working with different types of patients also helps in identifying subtle changes in patients, so if a problem is developing the nurse is ready to take appropriate action. Good research nurses are also people who are curious. We are always learning new ways to do things. The science is incredible."
Timmerman finds one of the best things about research nursing is having more time to get to know patients since she works with many of them month after month. However, the other side of the equation can also be one of the most difficult aspects.
"I've seen these studies benefit so many," Timmerman said. "But some of our patients have a terminal illness with little hope. The study may help them live longer or have a better quality of life. But after getting to know them well, when they are gone, you miss them. The extra time it takes for them to participate is precious, but they often consider it an opportunity to do something significant to fight back--a legacy to help others in the future, perhaps their own children or grandchildren."
- Karen Timmerman, RN-BC
- Jolene Lewis, MSN RN
- Jarred Younger, PhD