Although nurses have long been involved in clinical studies in which new medications are being monitored, hiring nurses as study administrators or principal investigators is relatively new.

This is not even a category of nurses broken out by the Department of Health and Human Services' National Sample Survey of Registered Nurses. Some pharmaceutical companies, too, tend to downplay this new use of highly educated, clinically qualified nurses.

Still, according to Richard Kneece, president of the Massachusetts Technology Corp., about 5 percent to 10 percent of the nurses recruited by the company's HireBio and HireNursing Web sites are snapped up by pharmaceutical and biotechnology companies.

Lest anyone assume nurses are used only because qualified Ph.D. or MD researchers are in short supply, the 4-year-old Center for Clinical Trials and Medical Device Evaluation at the University of Rochester is fully staffed by registered nurses.

The head of the center, Michael Ackerman, DNS, RN, has been involved in industry-sponsored research for a decade and now is the principal investigator on eight trials-in addition to working the floor as a nurse practitioner in the cardiac ICU two days a week and teaching acute care nurse practitioners another 40 percent of his time.

"We think this is novel," Ackerman said, referring to the all-nurse-all-the-time approach to research. "Nurses are usually at the data collection or coordination level."

At the center, they design, execute and document studies-involving such things as antibiotic resistance, wound management, a feeding tube locator system and the next generation of patient monitoring systems.

What does a nurse bring to the party that a physician may not? "This is cutting-edge stuff, the latest and greatest," Ackerman said. "As nurses, we know the exact things needed by the end user. We may even take it to the ward and use it. We can tell what works and what doesn't."

Research niches

Lorraine Frazier, DSN, NP, RN, a postdoctoral fellow, is an associate professor at the University of Texas-Houston Health Science Center School of Nursing and director of TexGen (Texas Medical Center Genetics), a collaborative effort of many institutions at the Texas Medical Center.

One of the TexGen projects is collecting DNA from 50,000 cardiovascular and cancer patients each year with a view toward identifying genes that contribute to these diseases, analyzing treatment outcomes and tapping the potential of genetics to tailor therapies to individual patients.

In other words, Frazier has carved out a niche in pharmacogenetics.

"I went and got a doctorate," she said. "I learned how to structure clinical studies. I think for a living. I know how to distinguish a demonstration from an experiment. I write grant requests."

Eventually, Frazier said, patients will take medicines keyed to their own genotype. Research like hers will lay the groundwork for this revolutionary approach to refining the present, somewhat crude system of "one size fits all."

Frazier, too, says her acute care background has stood her in good stead. "I know how hospitals work," she said. "I can get things done." Still, she says, in some meetings, she is the only nurse.

Peggy McHugh, MSN, director of clinical trial operations at Immunex Corp. in Seattle, started out in cardiology in the hospital setting and, after earning a master's in nursing, was recruited by the company formerly known as Rhone-Poulenc Rorer Corp. (now Aventis), to help develop cardiology and congestive heart failure compounds.

"I wrote and designed protocols, selected the investigators, designed the support paperwork and negotiated budgets with outside vendors," McHugh said. After that came the hard work-reviewing the data and going into the field to hospitals and doctors' offices to make sure the tests the researchers were doing were in keeping with the study design.

After 6½ years, McHugh moved to Immunex to oversee a group of 12 clinical research associates working on several drugs, including Leukine (sargramostim), Novantrone (mitoxantrone) and Enbrel (etanercept). Two years ago, she assumed her present post as director.

Forty-one people report to her and her teams are working on 34 protocols. "Nurses are used to working with physicians," she said. "They can start out running."

A typical day doesn't exist, according to McHugh. "I have a tremendous amount to do with resource management, money and people." Immunex is preparing to merge with Amgen, where McHugh will become director of medical affairs, taking her to yet another level in drug development: post-marketing.

A former Navy nurse with a background in intensive care and the emergency department, Linda Moy, MSEd, a critical care RN and manager of the medical review department at Abbott Laboratories in Chicago, said Abbott views nurses as "added value." They have been on the frontlines of patient care, she said. "Those skills are hard to find."

Moy's job is to search the literature, especially treatment protocols issued by major specialty professional groups, and make sure the company's product message and safety profile are in line with the latest treatments. For example, she would determine the latest protocol for management of hypertension and make sure the company's products are compatible with the recommendations. "We work to educate providers," she said.

Meetings are Moy's natural environment. "This is a team concept," she said. "Having been in the clinical setting, I can evaluate things in a more practical way than people who have spent their careers in marketing or business."

But she misses the bedside and may pick up a couple of shifts in the near future-just to stay up to date and close to patients, she said.

With a home health care background, Cynthia Fryhling Corbett, Ph.D., RN, an assistant professor at the Intercollegiate College of Nursing/Washington State University in Spokane, is involved, along with the College of Pharmacy, in tracking older adults in assisted living facilities and evaluating their risk factors for osteoporosis. Her staff then sends letters to the subjects' primary physicians, suggesting various medications and bone density studies.

"We don't necessarily recommend any one company's medication [even though that company is funding the research]," she said. "This is an indirect benefit for the drug company-building more general health knowledge in the general public and medical community."

Corbett is about to begin a two-year fellowship from Pfizer in which she will examine various aspects of diabetes. For now, she has no typical day. "I work with grad students on the studies. We do literature searches, data collection. I talk with the people in the study. I work with community agencies. I try to get people interested," she said.

Do the pharmaceutical companies view nurses as equals to doctors in the research arena? "No," Corbett said without hesitation. "The companies are most interested in those who can prescribe their medications. That is a fact of life."

But she is adamant about what nurses bring that's unique. "I know the clinical side," she said. "I can see if a contract is looking at something important-or if it's ivory-tower."

Pluses and perks

Aside from the autonomy and stimulating intellectual environment of drug research, many nurses like the working conditions. "Better pay and less stress," summed up recruiter Kneece. "You can live a 9-to-5 lifetime in the research area and operate in a corporate environment."

Nonetheless, McHugh still travels 40 percent of the time. "It can get tiring," she said.

Kneece advises that to get into the field, nurses need not only a knowledge of anatomy, but a background in the life sciences.

"I would take advanced study in biology or biochemistry," he said. "You need to know how drugs are developed."

Contact Star Lawrence at jkellaw@aol.com.