Behind the scenes of clinical research: from trial to triumph.

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The oncology field has seen its share of clinical advancements. Patients now may be able to receive therapies that are associated with less toxicity and are surviving their diseases for longer periods.

Such advances in cancer therapies have come from the work of clinical research teams around the world-healthcare professionals devoted to looking for the next best step in improving today's standard of care. Patients who participate in clinical trials are looking for treatment options that may offer them a chance for a better outcome in a highly monitored, safe environment, and they rely on their nurses to educate and protect them as they receive investigational therapies.

Clinical research nurse. Clinical trials nurse. Clinical research coordinator. Clinical research associate. The titles reflect a variety of roles for nurses who support the conduct of studies of new drugs, devices, or other interventions in the care of patients.

Oncology nurses who choose to work in the clinical trial specialty commit not only to providing compassionate, effective, and ethical cancer care but also to precisely following myriad regulatory and federal guidelines related to study conduct and human subject protections.

Nursing's Role in Clinical Trials

"The title and responsibilities of nurses working in clinical research can vary widely depending on the size of the institution and type of studies performed; however, the core competencies are the same," says ONS member and former Clinical Trial Nurses Special Interest Group (SIG) Coordinator Heidi Ehrenberger, PhD, RN, AOCN[R], a nurse consultant and adjunct faculty for the University of Michigan in Ann Arbor.

She led the SIG in developing the Clinical Trials Nursing Questionnaire[C] (Ehrenberger & Lillington, 2004), a tool to delineate the clinical trials nursing role. According to Ehrenberger, the essential domains and competencies for clinical research nursing practice include protocol assessment, planning for study initiation, subject recruitment, participation in the informed consent process, provision of education to learn about the investigational product, implementation of the study and continual evaluation for adverse events, data management and professional nursing activities such as supporting the discussion of ethical issues relating to the trial and the training of new research staff.

No matter the title, says Ehrenberger, "the first assumption one should make is that the individual is a licensed registered nurse. The ONS (2006) Position Statement on Cancer Research and Cancer Clinical Trials states, 'Coordination of clinical trials is accomplished best by RNs who have been educated and certified in oncology nursing.' This is important because nurses still use clinical research positions and titles (e.g., clinical research coordinator, data manager) that may not acknowledge or identify their profession. Second, we anticipate a background in oncology nursing practice and oncology nursing certification.

Third, we seek integration of the clinical research nursing role which requires additional knowledge of a highly regulated environment."

Ehrenberger adds, "Implementation of the clinical trial nurse role still varies tremendously from institution to institution and then from specialty to specialty. This is due, in part, to lack of standardization."

In discussing the confusion that often arises between the clinical research nurse role and the nurse researcher or scientist role, where the nurse serves as a trial's author and principal investigator, Ehrenberger notes, "The roles are best viewed along a continuum. Historically, there has been a dichotomy between research nurse and nurse researcher. This type of duality has significantly impacted the career opportunities of research nurses, schools of nursing and their curriculums, graduate programs, and funding priorities. What's fabulous today is that we are increasingly observing collaborations among the roles."

Ehrenberger also says that creating a seamless career trajectory is ideal; it's a win-win for the nursing profession.

Getting Involved in Clinical Research

So, how does a nurse move into a role in clinical research nursing? An emerging avenue is through participation in a graduate nursing program, such as the MSN in Clinical Trials Research program in the College of Nursing at Drexel University in Philadelphia, PA.

ONS member and current Clinical Trial Nurses SIG Coordinator Patricia McLaughlin, RN, MSN, AOCN[R], CCRP, a clinical assistant professor of nursing in the School of Nursing and Health Professions at Drexel University, leads the online program and notes that its 80 graduates have moved into a variety of roles in the clinical arena as well as in the pharmaceutical industry.

"The goal of the program is to allow the graduates to understand the whole gamut of what clinical research is about, not just to memorize the rules of Good Clinical Practice (the international ethical and scientific quality standards for human research)," says McLaughlin.

Students structure their learning experiences by choosing rotations in areas where they need to increase their knowledge, such as biostatistics, safety or regulatory affairs, or finance.

"Clinical research nurses are so valuable, but the role is often downplayed," says McLaughlin. "I hope that graduates of this program will move into leadership roles and increase visibility of the specialty."

In her work as SIG coordinator, McLaughlin wants to address what she believes is one of the biggest challenges for clinical research nurses-"that the role is undervalued compared to other clinical roles. We're still so often referred to as data managers, and this indicates a lack of knowledge of the broad expertise that experienced oncology nurses bring to this kind of practice."

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Essential Information for the Clinical Trials
Research Nurse: Clinical Trial Phases

Clinical trials involving the study of drugs and other
treatments are typically discussed in terms of four phases,
from those involving just a few participants (phase I) to those
involving hundreds or thousands of patients (phase IV). The
questions answered by each study phase differ as well.

Phase I          What is the best dosage and route of drug
                 administration? What are the physiological reactions
                 of the body to the drug?
Phase II         Is the drug or treatment effective against the cancer
                 being studied? What are the side effects?

Phase III        How does the drug or treatment compare to others
                 already available?

Phase IV         Is the drug or treatment safe and effective in
                 many people over time?

National Cancer Institute. (2006). Dictionary of cancer terms.
Retrieved July 2, 2007, from
http://www.cancer.gov/templates/db_alpha.aspx?expand=P

McLaughlin believes that with 881 current members, "such a big SIG should be able to focus our efforts and promote what we do." In fact, many members of the Clinical Trial Nurses SIG are promoting clinical trial nursing by working together on the second edition of the Manual for Clinical Trials Nursing, due out in 2008.

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The rewards of a career in clinical research include the stimulation of working with novel, promising anticancer agents, firsthand knowledge of new mechanisms of action and adverse events, and the opportunity to discover management strategies. Many clinical research nurses cite as a highlight of their careers the satisfaction of seeing an agent they worked with eventually being approved by the U.S. Food and Drug Administration and made commercially available.

From trials to tribulations, clinical trial nurses seek triumph for patients and the nursing profession.

Ehrenberger, H.E., & Lillington, L. (2004). Development of a measure to delineate the clinical trials nursing role [Online exclusive]. Oncology Nursing Forum, 31, E64-E68. Retrieved July 2, 2007, from http://www.ons .org/publications/journals/ONF/Volume31/ Issue3/pdf/517.pdf

ONS. (2006). Cancer research and cancer clinical trials [Position statement]. Retrieved May 1, 2007, from http://www.ons.org/publications/ positions/CancerResearch.shtml

National Cancer Institute Clinical Trial Cooperative Groups

The National Cancer Institute Cooperative Group Program was established in 1955. More than 1,700 institutions and thousands of physician and investigators in the United States, Canada, and Europe enroll patients in studies designed by the groups to study important issues of prevention, early detection, treatment, quality of life, and rehabilitation.

Following are the 12 clinical trial cooperative groups and the acronyms by which they are commonly known.

* American College of Radiology Imaging Network (ACRIN)

* American College of Surgeons Oncology Group (ACOSOG)

* Cancer and Leukemia Group B (CALGB)

* Children's Oncology Group (COG)

* National Cancer Institute of Canada, Clinical Trials Group (NCIC CTG)

* Eastern Cooperative Oncology Group (ECOG)

* European Organisation for Research and Treatment of Cancer (EORTC)

* Gynecologic Oncology Group (GOG)

* North Central Cancer Treatment Group (NCCTG)

* National Surgical Adjuvant Breast and Bowel Project (NSABP)

* Radiation Therapy Oncology Group (RTOG)

* Southwest Oncology Group (SWOG)

To find ongoing clinical trials, visit www.cancer.gov/clinicaltrials.

National Cancer Institute. (2006). NCI's Clinical Trial Cooperative Group Program. Retrieved June 27, 2007, from http://www.cancer.gov/cancertopics/factsheet/NCI/ clinical-trials-cooperative-group

Cancer Clinical Trials Cover Many Issues

Clinical trials research never lacks topics to study. Clinical trials in oncology address the entire cancer continuum, including

* Prevention: Can we prevent cancer through lifestyle and other modifications?

* Screening and early detection: How can we find cancer at its earliest stage?

* Diagnostics: What new tests or procedures may aid in our early detection of cancer?

* Genetics: Can we treat cancer with gene therapy?

* Treatment: What drugs, biological therapies, and other treatments are safe and effective for treating and curing cancer?

* Quality of life: How can we improve the lives of people surviving cancer?

National Cancer Institute. (2006). Clinical trials: Questions and answers. Retrieved July 2, 2007, from http://www.cancer.gov/ cancertopics/factsheet/Information/clini cal-trials

Kristen L. Fessele, RN, MSN, APN-C, AOCN[R], Contributing Editor

ONS Position Statement Highlights Importance of Cancer Research and Cancer Clinical Trials

"Cancer Research and Cancer Clinical Trials" outlines ONS's position on financial support for research regarding the prevention, treatment, and management of cancer. It also calls for the development of strategies to increase public awareness of clinical trials. According to the statement, oncology RNs are in the best position to coordinate clinical trials for patients with cancer and to design and implement trials to study patients' quality of life. For more information about ONS's position on clinical trials, visit www.ons.org/publications/positions/CancerResearch.shtml.

To obtain copies of this or any ONS position, contact ONS Customer Service toll free at 866-257-4ONS or e-mail [e-mail]. Positions also may be downloaded from the Publications area of the ONS Web site (www.ons.org).

Contributing Editor Kristen L. Fessele, RN, MSN, APN-C, AOCN[R], is the associate director for Human Research Services and an advanced practice nurse in the Breast Service at The Cancer Institute of New Jersey in New Brunswick.