When Felicia Menefee, RN, NP, ACNS, recruited patients for the landmark African-American Heart Failure Trial (A-HeFT), little did she know that the study would yield such positive results for them—or future patients.
Since African Americans with advanced left ventricular heart failure do worse than Caucasians in all phases of this condition, scientists wanted to see if adding a potent nitrate-vasodilator-duo to their standard therapy would make a positive difference in their symptoms, hospitalizations, and daily activities. What was the target of this National Institutes of Health study? A fixed-dose combination of isosorbide dinitrate (ISDN) plus hydralazine (HYD).
When researchers discovered that patients on the drugs indeed functioned better clinically than previously (some even energized enough to exercise), they halted the blind study prematurely. In doing so, they also handed the US Food and Drug Administration (FDA) enough data to demonstrate that survival and quality of life indeed increased, while hospitalizations decreased, on the medications. The FDA approved ISDN/HYD in June 2005 for heart failure therapy in blacks.
A-HeFT is just one of a myriad of NIH- and industry-sponsored drug and device trials Menefee has participated in during her 17 years as a nurse practitioner with Kansas City-based St. Luke’s Cardiovascular Consultants. Staffed by 48 cardiologists, many of whom are tied to academia, the practice provides ample opportunity for her to participate in clinical studies.
“Research is extremely important in advancing medicine,” she says. “Without it, health care stagnates. But with drug and other studies we can improve care. Sometimes a trial’s results are negative; sometimes they’re positive. But we won’t know unless we do it.”
Primed for Drug Studies
Perhaps you have the same curiosity as Menefee in advancing new pharmaceuticals or expanding indications for existing ones. What role can you play to help develop the next cutting-edge prescription or the newest use for an over-the-counter standard?
Truth is that unless you’ve piggy backed your nursing experience onto another degree—perhaps pharmacy, biochemistry, or medicine—your contribution likely won’t be in a drug company (or academic center) laboratory. Pharmaceutical scientists involved in the discovery or refinement of new medications typically bring masters and PhDs in the hard sciences to a company’s research and development function.
But that doesn’t mean your experience isn’t valuable. Clinical knowledge, critical thinking skills, and caregiver intuition can be a perfect match for other positions directly impacting medications. In fact, by parlaying and building on your background, you can ensure that what scientists produce in the laboratory is both safe and efficacious in real people. Whether you’re coordinating clinical drug trials in a patient setting, fielding adverse events for a pharmaceutical company, or playing another role, you can find a rewarding frontline niche.
As Sherry Banez-Muth, RN, manager of coordinating services, Center for Clinical Studies, Washington University School of Medicine, St. Louis, observes: “It’s definitely satisfying when you see people taking a new treatment that may be life-changing. It’s a good feeling to say, ‘Wow, I contributed to this.’”
Coordinating for Results
The good news for nurses and nurse practitioners is that you don’t have to stray far from a patient setting to be part of the drug development process. Once scientists have tested their hypothesis to determine that a preparation developed in the lab may indeed help with a specific indication, the scene shifts to the FDA for a human study protocol approval. When the regulatory agency is on board, sponsors can enlist multiple clinical trial sites—health systems and large medical practices—for the Phase I to IV (and post-marketing) human studies.
Much of the work at those locales rests with nursing professionals, point people in the day-to-day operations of a drug trial. As clinical research or study coordinators, they juggle multiple tasks in making the protocol work. They not only train supporting cast members to find, screen, enroll, monitor, and collect data on participants, but they’re often on board from the onset, helping principal investigators prove that a health provider has what it takes—in experienced staff, adequate space, and access to the right patient demographics—to move a protocol forward.
As a director of clinical research for the Dallas-based Baylor Health Care System, Jennifer Thomas, RN, BSN, MS, CCRC, works side-by-side with investigators, first reviewing potential drug or device trials to ensure that they’re a good fit both financially and clinically for the institution. Thomas had her nursing skills tucked neatly under her belt when she earned a clinical research administration masters to even the negotiating playing field with sponsors over start-up costs and other numbers. “It helped me look at the bigger picture,” she says. “I’m better able to account for everything we need to do to go into a trial.”
Although Thomas no longer conducts individual studies, her imprint is widespread since she provides education and other resources to 40 professionals who manage from 70 to 100 investigational drug, device, and prevention studies, covering a multitude of conditions from diabetes to transplant research. She makes sure others are knowledgeable about a particular study and ready to conduct it according to regulations and good clinical practice.
That means becoming familiar with all aspects of the protocol, a regulatory document that can range from a mere 20 pages to a 500-page tome. It covers every possible nuance, from the hypothesis and research behind the drug to the goals, criteria, and requirements for participation. Whether the information is gleaned from principal investigator meetings, in-service tutorials, or other sources, mastering the fundamentals and logistics of a protocol is critical in running it correctly and consistently with other centers so results are valid.
“If there are too many variations, the sponsor can’t tell what’s causing a problem,” says Lynn Fukushima, RN, MSN, FNP, MBA, CCRC, nurse coordinator for the Keck Medical Center of the University of Southern California. “Is it the proposed medication itself or something else? We have to be very meticulous in our record-keeping so there’s no doubt.”
Fukushima wears many research hats in navigating drug studies related to cystic fibrosis and other pulmonary or lung diseases. For starters, she also helps her physician-colleagues determine if a clinical drug trial is appropriate by submitting information to the institutional review board for an up-or-down decision. Because her job includes budgetary tasks, she earned a health care administration MBA to better grasp the financial implications of a study.
In terms of each protocol, Fukushima sometimes works alone, organizing all aspects of a study, while other times, she’s coordinating with staffers. Whatever the case, her patient involvement changes with each trial stage. Phases I and II, for instance, can be intense since researchers are looking closely at efficacy and safety. She may see subjects weekly, daily, or even several times a day for blood draws and other procedures. During phases III, IV, and post-marketing, the individual interaction diminishes since sponsors are no longer tracking efficacy, but safety in an expanded universe of patients.
Whatever the stage, the paper chase with a clinical drug trial demands the kind of attention to detail and familiarity with medical jargon and charts that usually fit nursing professionals to a T. The skills you’ve likely established in training and honed in practice can provide an important cornerstone for managing the administrative and patient-contact components of any given study. But it’s also the ability to stay up-to-speed, think outside the box, and respond with on-the-spot analysis or critical thinking that’s important. Each protocol is replete with guidelines, but you still need to accommodate new information and unexpected turns-of-events.
In managing a support service unit for principal investigators throughout Washington University School of Medicine, St. Louis, Banez-Muth is used to the structured training and continuing education necessary to get a trial up, running, and producing valid results.
Of the 35 to 40 active NIH- and industry-sponsored studies she and her seven coordinators target at any given time, the phase II to IV drug trials represent a spectrum of urological and gastrointestinal targets. Whether Banez-Muth is personally managing a trial for a principal investigator or overseeing the work of others, she not only has to be organized but nimble on her feet. “As black-and-white as you would like things to run, it’s never that way. There’s always one patient who falls outside the box,” she says. “When that happens you want to make sure that you’re doing what you can to keep this person safe during the protocol.”
From Tuskegee to Transparency
Indeed, beyond data integrity, the primary task of nursing professionals involved in a clinical drug trial is to protect the subjects they seek, find, vet, enroll, and follow. From the moment coordinators scan medical records, tap health care providers, or reach into the community to find subjects, their focus has to be on complete honesty and concern about someone’s health and well-being.
That wasn’t always the case, given this country’s sometimes chilling research history, especially in regards to minorities. The infamous Tuskegee syphilis experiment, for instance, may have started in 1932 to chart the progression of an untreated sexually transmitted disease in black sharecroppers. Yet, by the time it ended in 1972, it had put hundreds of them at medical risk because US public health scientists and their local physician-partners withheld what had become standard-of-care treatment: penicillin. Even decades after whistleblowers shut it down, Tuskegee has left an indelible mark, particularly among African Americans.
Thankfully, clinical trials today are light years from Tuskegee, not just in terms of bioethical standards but also in practical safeguards. Study coordinators can point to a drug process so rigorous and regulated by the sponsor, the FDA, institutional review boards, and other agencies that safety rules at every turn. Patients are monitored so closely with high-tech imaging and other services that care often exceeds what they receive nominally from their personal physicians. “The wonderful thing about research is that you get excellent follow-up care,” says Menefee. “It can be a very special opportunity for participants.”
But nurses must be both transparent and on their toes in engaging candidates with a medical history that matches a given protocol. Informed consent is the primary tool they hold in their quiver to ensure that every enrollee understands every relevant specific—possible risks, benefits, and commitments—of a given study. But in outlining the parameters, they also target their rights. Distilling the caveats is important for every clinical trial, especially those that demand much of a participant, perhaps even an invasive procedure, with no guarantee of positive results.
In fact, making promises that someone will receive an active ingredient or that it will work with no side effects, is a trial taboo. The only guarantees nursing professionals should be sharing with their enrollees are that they’ll be good patient advocates, pursuing everything possible to ensure a safe experience. That includes collecting vital signs and good data with each office visit, addressing any side effects or adverse events, and keeping everyone, including a patient’s personal physician, apprised of important changes. As one coordinator notes: “You’re asking people to participate in a clinical trial from which they may or may not derive any benefit. So establishing trust and rapport is important.”
Whatever the specifics, vetting presents a great opportunity for minority nursing professionals to convince fellow patients of color that their participation in a study is critical. Given your own sensitivity to the cultural mores and concerns of a community, you can be a key link in dispelling any myths about drug research while bringing volunteers into the fold.
In engaging her enrollees, Thomas, for instance, makes sure they know that they’ll never be asked to sign on to a Baylor study without someone reviewing every paragraph of the consent form with them. More importantly, if it’s not a good fit, they can leave at any time. “I understand the sensitivity among African Americans enrolling in research studies,” she says. “Hopefully I can educate them so they have a good understanding and they’re willing to say, ‘OK, I will participate in this.’”
Similarly, when Judith A. Rivera, MSN, recruits subjects for both NIH- and pharma-sponsored memory trials, her goal is to find an ethnically diverse pool of people when the study merits it. As a Latino nurse practitioner and principal study coordinator for the University of California-San Diego’s Comprehensive Alzheimer’s Program, Rivera is well aware that dementia is a serious health issue among minority, as well as majority, Americans. Unfortunately, in some ethnic communities memory loss is often dismissed as simple aging rather than a potentially serious disease.
But by targeting culturally and racially diverse subjects for a slew of drug and other studies related to memory, researchers at her institution are giving vital information to pharmaceutical companies about all of the people, not just Caucasians, who might need their products. More importantly, they’re also raising awareness among enrollees about the potential pharmaceuticals—albeit under study—that might help them remain active and functioning. “We want them to be as independent as possible for as long as possible.”
Monitoring for Safe Outcomes
Making sure that a participant isn’t compromised during a drug trial is an important part of realizing any positive results. From phase I to post-marketing, nursing professionals are not only helping patients navigate the terrain of a protocol, but they’re also gathering information about a drug’s safety and effectiveness.
Detecting and forwarding potential problems to a sponsor is a natural for nursing coordinators since their training and frequent interactions often give them a pulse on what people are experiencing. “Some nurses have a sixth sense about how a patient is doing,” Fukushima says. “If they see a frown on a face or hear unusually short answers, they may be a little more aggressive in investigating the cause.”
But overseeing a clinical trial isn’t the only way to determine if a drug is working well or not so well in a patient. In fact, many nurses are finding satisfying ways to use their critical thinking and detail skills in other research-related venues. From pharmaceutical companies to clinical research organizations (CROs) and other patient service firms, prospects abound for managing and monitoring trials as well as educating and tracking subjects. Besides sales and marketing functions to promote approved products further down the line, the activity usually centers on making sure medications aren’t hurting users.
As a clinical safety specialist for GlaxoSmithKline’s (GSK) Global Clinical Safety and Pharmacovigilance Division, Shannon Hart Anderson, BSN, RN, JD, also manages adverse event reports—unexpected and potentially harmful reactions—for a bevy of pharmaceuticals bearing the GSK imprimatur. From over-the-counter remedies to prescriptive medications, her potential targets include therapies for a wide spectrum of benign and serious diseases. “We’re like the safety police,” she says, “We have to make sure that our products aren’t harming the public.”
From her berth in GSK’s US headquarters located in Research Triangle Park, North Carolina, Anderson processes initial complaints from consumers, health professionals, sales reps, and even the FDA. She then collects follow-up information, which is entered into a safety database that serves as grist for further investigation as well as the regulatory agency reports she also must prepare. To capture the most accurate information possible, Anderson routinely relies on the logical reasoning, problem-solving, and even communication and advocacy skills she’s honed as both a nurse and an attorney.
But the most important roadmap may be the positions she’s held previously with CROs, outside firms hired by a pharmaceutical company to provide a wide range of support services. That may include managing the day-to-day operations of a drug study or even serving as an outside monitor, making sure that each site follows a protocol correctly and meets FDA standards. In honing the pharmacovigilance skills she now uses at GSK, Anderson mastered the nuances of adverse event reporting and the importance of being detail-oriented as a drug safety scientist. “We need to know the ins and outs of what happens,” she says, “so that we can look for trends that may prompt us to change our label or even our product.”
Likewise, as a diabetes-musculoskeletal medical professional for Indianapolis-based Eli Lilly and Company, Marla Neal, RN, BSN, MHCA, educates health professionals about drugs and devices that may help their patients. When physicians and other practitioners pose questions of the sales force, she’s tapped to provide the definitive answer. Neal accesses every possible database and medical professional to respond to each request. She also updates sales members about current clinical trials while helping them understand how each Lilly product impacts a disease process.
But it’s her other priorities—capturing accurate information about unexpected side effects and product complaints—that really tap her nursing skills. “Oftentimes patients don’t even realize that they’re having an adverse event,” she says. “So I’m very diligent about asking the direct questions and picking through the subtle conversation for clues. It’s critical for making sure that our drugs are really improving the lives of our customers.”
Adds Shannon Bradley, RN, a telehealth nurse educator and team lead for The Lash Group, a Charlotte, North Carolina-based patient services support company: “When you’re speaking to someone on the phone, you need to ask the right questions because people don’t always come forth with information on their own. You have to help them identify what’s important.”
Bradley is the nursing voice on the other end of the line when patients, pharmacists, and other health care professionals make contact with her company’s Dallas office, usually by dialing the “800” reporting number on a medication’s packaging. Using her clinical intuition, honed as a hospital neonatal intensive care unit and trauma nurse, she collects and reports adverse events linked to medications manufactured by one of her firm’s pharmaceutical company clients. It’s a varied list, from digestive and fertility drugs to oncology and neurology medications.
But her primary role is often to educate and support patients in staying the course with their medication. For no matter how many drugs move from clinical trial to market, they aren’t effective if they’re not taken according to directions. “We want them to understand,” she says, “the significant impact medication compliance has on their therapy outcome.”
Reaping Rewards: Better Health and Other Benefits
Besides bedside nursing, there may not be a better way to use your skills and intuition than in drug development. You might not be the academic researcher or laboratory scientist behind a preparation, but you can help bring a drug the final distance via other roles. Truth is, by participating in the process once it involves ordinary people, you’re witnessing cutting-edge medications making dramatic differences in the quality of real lives. A grandmother who couldn’t comb her hair or walk without a cane before an arthritis drug trial, for instance, performs both tasks eight months into it. A grandfather who couldn’t play with his grandchildren now travels across country to romp with them.
As to Menefee, the landmark A-HeFT trial left her with many good feelings about being a co-investigator in the drug improvement process. Even though she didn’t place many African Americans in the trial, the protocol has worked so well since that now whenever a black heart failure patient in her practice meets the medical criteria, she prescribes ISDN/HYD to optimize their other meds. She hasn’t been disappointed yet.
The medication duo not only gives her more options in extending quality of life, but also serves as proof that research works. Every trial success, as well as every study failure, just reinforces her belief in the benefits of being part of the process. “Before a drug is even approved, I already know something about it,” she says. “So when it’s brought to market, I don’t need a sales rep to tell me how great it is. I know because I’ve already been involved with it. I’ve seen it work!” MN
Running the Gauntlet
The lengthy and complicated process of moving a drug to market is broken down into various phases. After a pre-clinical development stage during which animal and other laboratory tests have proven that a product is initially safe, the emphasis shifts to human or clinical trials. Although most drugs never reach that stage, the ones that do undergo a rigorous process in winning FDA-approval.
• Phase I: A drug is tested on 20 to 80 healthy volunteers not only to see if it’s initially safe but also to determine the most frequent side effects.
• Phase II: If the drug hasn’t produced unacceptable levels of toxicity during the first phase, it’s tested in a few dozen to 300 subjects with the condition or disease to obtain preliminary data on how well it’s working.
• Phase III: If a drug demonstrates a good level of effectiveness, it’s tested in an expanded pool of subjects, from several hundred to about 3,000, to see how it works with different dosages, populations, and in combination with other drugs.
• Phase IV and other post-marketing studies: Conducted after the FDA has approved a given drug, these trials are used to gather additional information about safety, efficacy, and even other uses.
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