Involve. Supporting you. Supporting your patients with cancer
You can promote excellence in oncology clinical trial nursing and quality care in cancer clinical trials by:
- Supporting the care of patients and families involved in clinical trials
- Promoting the highest professional standards of oncology clinical trial nursing
- Studying, researching, and exchanging information related to clinical trials
- Encouraging other oncology nurses to specialize in the practice of oncology clinical trial nursing
- Supporting the individual and collective professional advancement of oncology clinical trial nurses
- Sustaining an organizational structure and operation that is responsive to the changing needs of Clinical Trial Nurses SIG members and the populations they represent.
Understanding Clinical Trials
Clinical trials try to answer scientific questions and to find better ways to prevent, diagnose, or treat cancer. There are 4 primary types of clinical trials:
- Treatment trials – Test new treatments, such as investigational cancer drugs, new approaches to surgery or radiation therapy, new combinations of treatments, or new methods such as gene therapy.
- Prevention trials – Test new approaches, such as investigational medicines, vitamins, minerals, or other supplements that may lower the risk of a certain type of cancer.
- Screening trials – Test the best way to find cancer, especially in its early stages.
- Quality-of-life trials (also called supportive care trials) – Explore ways to improve comfort and quality of life for cancer patients.
Most clinical research involving the testing of an investigational drug progresses in an orderly series of steps, called phases.
- Phase I trials – These first studies in humans evaluate how an investigational drug should be given (by mouth, injected into the blood, or injected into the muscle), how often it should be administered, and at what dose it can be given safely.
- Phase II trials – A phase II trial continues to test the safety of the drug and begins to evaluate how well the investigational drug works.
- Phase III trials – These studies test an investigational drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. A participant usually will be randomized to the standard treatment group or to the investigational treatment group.
- Phase IV trials – Phase IV trials occur after a treatment has been approved and is being marketed. The purpose of phase IV trials is to evaluate the side effects, risks, and benefits of a drug over a longer period of time and in a larger number of people than in phase III clinical trials. Thousands of people are involved in a phase IV trial.
What Clinical Trial Outcomes Mean to Patients
For people living with cancer, statistics provide a sense of what to expect based on previous experiences with other patients. The Kaplan-Meier curve is what's known as a survival curve. It is a graph that shows the results of analyses of survival rates for people with cancer. The Y-axis (vertical) shows the proportion of people surviving, while the X-axis (horizontal) shows the time since the initiation of treatment or observation.
A survival curve always starts with 100% survival at the beginning and then provides the proportion, or percentage, of people surviving at any given time after the beginning of observation. If different people begin being treated or observed at different times, the curve always represents the individual person's experience from the start of observation. For example, if two people start on a medication 6 months apart but both live 1 year after beginning treatment, they are both counted as surviving 1 year on the Kaplan-Meier curve. The point of statistical analyses like those shown on a Kaplan-Meier curve is to estimate survival based on time and events, and it can help manage patients' expectations as they work to manage their disease. The following is an example of what a Kaplan-Meier Survival Curve looks like:
Learn about the Value of Clinical Trials in oncology.