Editor’s note: This is the first in a four-part series on clinical trials written by nurses at the National Cancer Institute at the National Institutes of Health.
You’re a staff nurse on an orthopedic surgical unit in a large community hospital. Today, you’re assigned to Madeline Smith, a 78-year-old woman admitted to your unit after surgical repair of a left femur fracture. Diagnosed 3 years ago with stage II breast cancer, she developed acute pain in her left upper leg last week. Evaluation revealed a pathologic fracture secondary to metastatic breast cancer. A computed tomography (CT) scan of the abdomen showed multiple liver lesions, presumably metastatic disease. Mrs. Smith says her doctor plans to put her in a "study" and she is scheduled to receive "an experimental drug’" today. She confides that although she believes her doctor is "doing what he thinks is best for me", she’s uncertain about this new treatment, but doesn’t want to upset her doctor.
As Mrs. Smith’s nurse, what’s your next move? Where will you find information regarding the "study"and the "experimental drug"? How will you respond to her concerns? Are you prepared to care for a patient on a clinical trial?
Meeting the challenge
More than 14,000 clinical trials are underway across the country, so chances are you’ll encounter a patient participating in or considering a clinical trial—if you haven’t already. Nurses play a vital role in clinical trials, from ensuring patient safety and advocacy to educating patients about clinical trial participation. However, unless they’ve chosen clinical research/clinical trials as a career path, there’s little instruction available to prepare nurses for this challenge. It’s vital that nurses in practice, education, and management ensure that nurses understand clinical trials.
This four-part series will help prepare you to care for patients like Mrs. Smith. It will give you a foundation for understanding clinical trials, provide valuable information about clinical trial resources for nurses, and spotlight potential career opportunities in the area of clinical trials. This first article focuses on what clinical trials are and how they’ve evolved and gives basic tips on caring for patients who participate in these trials.
What are clinical trials?
The "study" Mrs. Smith referred to is a clinical trial, a type of clinical research used to determine whether new drugs or treatments are safe and effective. Clinical research is research conducted on human beings (or on material of human origin, such as tissues, specimens, and cognitive phenomena [research related to thoughts and behaviors, for example, cognitive decline]), with the goal of generating useful knowledge about human health and illness. Clinical research participants may be patients or healthy volunteers. For examples of clinical research, see Types of clinical research.
Types of clinical research
- Studies of mechanisms of human disease
- Studies of therapies or interventions for disease
- Studies to develop new technology related to disease
Epidemiologic and behavioral studies
- Studies that examine disease distribution
- Studies that examine factors that affect health
- Studies on how people make health-related decisions
Outcomes and health services research
- Studies that seek to identify the most effective and efficient interventions, treatments, and services
- Comparative effectiveness research
Clinical trials are one type of clinical research that seeks to answer a scientific or medical question about the safety or potential benefit of an intervention, such as a medication, device, teaching concept, training method, or behavior change. In addition to treatment trials, clinical trials are conducted to improve our ability to prevent disease, screen for or diagnose disease, and manage signs and symptoms related to disease or treatment. (See Types of clinical trials.)
Types of clinical trials
- Test experimental treatments
- Test new (investigational) drugs or combinations of drugs
- Test new devices
- Test new approaches to surgery or radiation therapy
- Seek better ways to prevent disease in people who’ve never had the disease
- Prevent a disease from returning
- Use various approaches, which may include medicines, vaccines, vitamins, minerals, or lifestyle changes
- Seek better tests or procedures for diagnosing a particular disease or condition
Test the best way to detect certain diseases or health conditions
- Include supportive care trials
- Explore ways to improve comfort and quality of life for individuals with chronic diseases
Results of clinical trials are a vital piece of the foundation on which we build evidence-based practice. Clinical trials are the only way new devices, diagnostics, drugs, and biologics are approved, and they provide the pathway for changing practice. Nursing practice has moved from tradition and intuition to evidence, much of which results from clinical research and clinical trials—the gold standard for evidence.
Clinical trials: evolution and expansion
The practice of comparing one intervention to another and observing the results began hundreds of years ago. The evolution of science, technology, practice, and innovation through the centuries forms the foundation for today’s clinical trials. Though many pathways for funding and conducting research exist, the National Institutes of Health (NIH) serves as an excellent starting place for understanding the evolution and expansion of clinical trials and clinical research in the United States. (See About the NIH.)
About the NIH
The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the nation’s medical research agency and the largest funder of grant-funded clinical research in the United States. NIH traces its roots to 1887, when from a one-room laboratory the earliest clinical trials focused on the infectious diseases of cholera and yellow fever. During World War I, NIH studies traced the cause of anthrax outbreaks among the troops to contaminated shaving brushes. From these early discoveries, NIH has grown to include 27 different components called Institutes and Centers, each with its own specific research agenda.
Historically, NIH-supported clinical research and clinical trials were performed only in academic medical centers, specialized research settings, or dedicated clinical research units. However, both the number of trials available and the number of locations offering clinical trials have expanded exponentially in the last two decades. Today, NIH sponsors more than 5,500 clinical trials and 80% of NIH’s research activities are conducted by scientists working in every state and many countries around the world. In 2006, more than 2 million people participated in government or industry-funded clinical trials.
The cancer clinical trial program of the National Cancer Institute (NCI) serves as one example of the expanding presence of clinical trials beyond academic and specialized settings. In the mid-1950s, NCI funded the Clinical Trials Cooperative Group Program. Fifteen groups organized by geography, disease type, or therapeutic modality provided cancer specialists located at academic medical centers, with clinical trials to test new anti-cancer agents developed by NCI. A decade later, the scope of research broadened to incorporate multidisciplinary studies involving surgeons and radiation oncologists.
However, despite increased access to cutting-edge research at the NCI-designated Comprehensive Cancer Centers, only a fraction of the country’s cancer patients were treated at these specialty centers between the 1950s and early 80s. NCI’s Community Clinical Oncology Program (CCOP) network was created in 1983 as a national mechanism for community-based physicians to partner with academic investigators. The primary goal was to accelerate implementation of NCI clinical trials for cancer prevention, control, and treatment. This network connects 3,375 participating community physicians and 395 participating hospitals to NCI’s clinical-trial infrastructure, creating the opportunity for patients and physicians to participate in state-of-the-art clinical trials in their local community. The minority-based CCOP program, started in 1990, funded 16 U.S. locations as a companion mechanism to reach areas with large minority populations. It became the cornerstone for accrual to NCI’s cancer-treatment clinical trials as well as cancer prevention, cancer control research, and quality-of-life studies.
More recently, NCI funded the Community Cancer Center Program (NCCCP) to test the concept of a national network to expand cancer research and deliver the latest, most advanced cancer care to more Americans in their home communities. Today, there are 66 NCI-designated cancer centers, 63 CCOPs and minority-based CCOPs, 30 NCCCP sites, and 46,000 registered investigators.
Clinical trials today
The NCI experience is only one example of how clinical trials have moved from specialized to mainstream settings. In addition to the government, the pharmaceutical industry also is a major sponsor of clinical trials. These trials are conducted in various settings, including physician offices. Clinical trials vary in size from those involving a single center in one country to multicenter trials conducted in multiple countries.
Regardless of the size or setting of the clinical trial, all human subject research is governed by ethical codes, laws, regulations, and international guidelines. The clinical protocol outlines the plan for the clinical trial and details the study requirements. (Subsequent articles in this series will describe these aspects in detail.)
Nurses: Are you prepared?
Given the expansion of clinical trials from academic medical centers to community settings and the movement from specialized research environment to the mainstream, nurses must be aware, informed, and confident in their ability to perform the functions related to clinical trials. Whatever your practice setting, you’re increasingly likely to encounter patients who are considering or actively participating in a clinical trial, or who have already participated in one. As a clinical nurse, are you prepared to:
- Identify patients participating in a clinical trial?
- Answer the patient’s and family’s questions regarding clinical trial participation in general? Answer their questions about a specific study? Explain general concepts, such as randomization or blinding?
- Locate information you need to safely administer the drug (such as side effects and drug-drug interactions) if it’s not in the formulary or Physician’s Desk Reference?
- Accurately document investigational medications or procedures in the medical record?
- Perform special procedures that are timed and must be followed precisely to avoid a protocol deviation?
- Collect specific research data in addition to standard-of-care information (such as obtaining sitting, standing, and lying blood pressures)?
- Identify and report possible adverse events to the clinical research team within the appropriate time frame?
As a nurse manager or nurse educator, consider these issues:
- Does your organization have a standard process in place for identifying patients participating in a clinical trial?
- How will you locate the necessary study documents? The informed consent form?
- What resources are available to support staff in caring for patients on clinical trials?
- What are the safety and other implications for administering an investigational agent?
- What resources are available to help staff educate patients and families about clinical trials?
- What resources are available for staff to learn about clinical trials?
Obviously, clinical trials touch nursing at multiple roles within an organization. Until academic programs integrate didactic information about clinical trials and ensure clinical opportunities that expose students to clinical trial participation, employers must assume the responsibility to become familiar with nursing roles and responsibilities pertaining to clinical trials. Subsequent articles in this series will help meet this responsibility.
Increasing clinical trial participation: Nurses are part of the solution
Clinical trials are the lifeblood for developing new drugs and other products and interventions that may improve human health. Findings from clinical trials provide the foundation for evidence-based practice. Yet because of insufficient enrollment of trial participants, 40% of clinical trials close without answering the scientific question they posed. Fewer than 6% of eligible adults with severe, life-threatening illnesses participate in clinical trials. However, 75% of adults say they’d be willing to enroll if they knew clinical trials were available to them. Voluntary participation of healthy individuals and patients in clinical trials is the linchpin to improving health.
Educating nurses about clinical trials can raise public awareness about clinical trials as a potential option for patients. Nurses already are trusted by patients; by knowing the basics of clinical trials, they may hold the key to improving participation rates in clinical trials. Nurses have long been advocates for patients. With enhanced understanding of clinical trials, they can begin to advocate for clinical research.
Linda K. Parreco, Elizabeth Ness, Annette Galassi, and Ann O’Mara work at the National Cancer Institute, NIH, in Rockville, Maryland. Parreco and Galassi are public health advisors for the Office of Communication and Education; Ness is the director of staff development at the Center for Cancer Research; and O’Mara is the head of Palliative Care Research in the Division of Cancer Prevention.
American Association of Colleges of Nursing. The Essentials of Baccalaureate Education for Professional Nursing Practice. October 20, 2008. www.aacn.nche.edu/education-resources/BaccEssentials08.pdf. Accessed October 16, 2011.
American Nurses Association. Nursing Standards. http://www.nursingworld.org/MainMenuCategories/ThePracticeofProfessionalNursing/NursingStandards.aspx. Accessed October 18, 2011.
National Cancer Institute, Division of Cancer Prevention. Decades of Progress: 1983-2003 Community Clinical Oncology Program. http://dcp.cancer.gov/files/programs-resources/pubs/ccop20th/book.pdf. Accessed October 16, 2011.
National Institutes of Health. NIH History. www.nih.gov/about/history.htm. Accessed October 16, 2011.
The Center for Information & Study on Clinical Research Participation. Information about Participation and Clinical Trials by Ethnicity, Age and Gender: Volunteer Demographics.
www.ciscrp.org/professional/facts_pat.html#7. Accessed October 7, 2011.