What are Clinical Trials?
Cancer treatment clinical trials are research studies to find better ways to treat cancer. Clinical trials often compare the most accepted cancer treatment (standard treatment) with a new treatment that doctors hope will be better. During a trial, more and more information is gained about a new treatment, its risks and how well it may or may not work.
Who can Participate in Clinical Studies?
Each trial has a list of criteria for who can participate, including age, sex and type of disease and its progression. Some studies are restricted to people who haven't started treatment, while others focus on people who've tried other options first.
Anyone can participate in a clinical trial if they meet the criteria of that trial and wish to participate. Patients take part in clinical trials for many reasons. Usually, they hope for benefits for themselves. They may hope for a cure of disease, a longer time to live, and/or a way to feel better. Often, they want to contribute to a research effort that may help others. The patients in a clinical trial are among the first to receive new research treatments before they are widely available.
How do You Enroll in a Clinical Trial?
The National Institutes of Health posts listings of thousands of clinical trials online. In Whatcom County, the Medical Oncologists and the Radiation Oncologists participate with the following national cancer clinical trials:
- CTSU (Clinical Trials Support Unit)
- GOG (Gynecologic Oncology Group)
Through Fred Hutchinson Cancer Research Center, we are able to participate and register patients.
- SWOG (Southwest Oncology Group)
We are 1 of more than 100 community centers in the United States who can register patients to their adult cancer clinical trials.
- NSABP (National Surgical Adjuvant Project for Breast and Bowel Project)
It is through Fred Hutchinson Cancer Research Center that we can participate in these clinical trials.
- RTOG (Radiation Therapy Oncology Group)
We are 1 of 4 affiliate members of RTOG in the state of Washington who can register patients to their clinical trials.
How Much Will You Know About the Clinical Trial Treatment?
Study facilitators provide what's called an informed consent document, which contains all of the information you'll need to know about the study before deciding whether to participate. The information should include details about the experimental treatments, tests that may be given, the possible risks and benefits of the tests and experimental treatments as well as information about any standard treatments available for your condition.
Before starting a trial, you must sign an informed consent form. This form explains what will happen during the trial and the known risks and benefits of participating in it. The form must explain this information in words you can understand. Researchers aren't allowed to pressure you into signing up for a trial if you prefer not to get involved.
Signing the informed consent form means you agree to participate in the trial as explained by the researcher and described on the consent form. If you later decide to leave the study, you may do so at any time without any penalty.
If you have any questions about the trial, ask before you agree to participate. Questions you might want to ask include:
- Who sponsors the study? Who has reviewed it and approved it?
- What is the purpose of the study?
- Why do researchers believe the new treatment being tested may be effective?
- How are the study data and patient safety being checked?
- What will be expected of you?
- Is it possible that you might receive a placebo?
- What benefits or risks can you expect if you take part in this study?
- How long will the study last?
- What happens if your condition gets worse during the study?
- What if you don't want to take part in the study? What other treatment options do you have?
- Where will your treatment take place?
- What is my health insurance likely to cover?
- Will you need to pay for any part of the study, including doctor visits and routine tests?
- How will your participation in the study affect your daily life?
- What happens at the end of the study?
- Will you be told the results of the study? When?
- Who will know that you're participating in the study?
- Who can you contact if you have more questions?
How are Trials Conducted?
Clinical trials follow a scientific action plan (protocol). It outlines:
- Who may participate
- How many people will take part
- What the treatment plan entails
- The type and frequency of tests
- How the results will be measured
- The reasons why a study may be stopped
- The situations in which researchers may stop giving the treatment to participants
- The likely or known side effects of the treatment
- The possible benefits of the treatment
The clinical trials offered through PeaceHealth St. Joseph Medical Center are written by research groups and reviewed and supported by the National Cancer Institute. In addition, an institutional review board (IRB) reviews the protocol. The IRB includes people from the community as well as health care professionals. It reviews all protocols to be sure that participants are treated humanely and ethically. The IRB also discusses such issues as whether the likely benefit of the treatment is worth its risk. A data safety monitoring board also oversees the trial. This board is composed of people who aren't involved in the development or administering of the study. Every six months, they review the data all the clinical trial sites have submitted concerning participants' treatment and side effects. The data safety monitoring board can step in and stop the study at any time if members see the treatment has too many side effects or if the treatment isn't helping. A trial can also be halted by the data safety monitoring board if the treatment is proving to be better than the standard treatment. It may be working so well that it should be made available to people outside of the clinical trial.
What Types of Clinical Trials are Available?
When a treatment is tested in people, it always takes place in distinct phases. Each phase has a different purpose. Treatments being tested must go through the testing phases in order, including:
Phase I Research
This is the first step in testing in humans. At this stage researchers study:
- How much of the treatment to give
- How much the human body reacts to the treatment
- How much can be given safely
- The best way to give the treatment
- Any harmful effects
Earlier studies have often only been done in animals, so the approach may pose some risks when first tried in humans. Researchers try to minimize these risks by starting with very small doses, and then increasing the dosage only if no or minimal side effects occur. Only a limited number of people who would not be helped by existing treatments are included in these trials. Between 20 and 80 volunteers typically participate in Phase I studies, which usually last several months. About 70 percent of the drugs tested in Phase I are successful and move on to the second phase of research.
Phase II Research
This phase focuses on determining whether a new approach works the way it's intended. For example, does it shrink a tumor or improve the results of cancer-related blood tests? Researchers also monitor you for common short-term side effects that occur with the therapy. Some things aren't yet known about the treatment, so risks are still present. Several hundred people may participate in these studies, which can last from several months to years. On average, 33 percent of the drugs tested in Phase II are successful and move on to the third phase of research.
Phase III Research
This phase usually begins only after a treatment shows promise in phases I and II. At this stage, you're often assigned randomly to receive either the experimental treatment or the standard treatment. This helps to avoid bias in the results.
When no standard treatment exists for a cancer, some studies compare a potential new treatment with a placebo - a pill or liquid that looks like the new treatment but has no active ingredients. Before you participate in any trial, you'll be told whether a placebo will be involved. If you agree to participate, you must be willing to take a chance that you'll get the placebo and not the active treatment. Neither you nor your doctor can control which you will receive.
Phase III trials provide more information about the safety of the experimental treatment and demonstrate whether the standard or the experimental treatment group has better survival rates and fewer side effects. These trials usually include several hundred to several thousand people and last from one to four years. Large trials make it easier to estimate what would happen if the experimental treatment were available to everyone with the condition. About 25 percent to 30 percent of drugs tested in Phase III are successful and go on to the government for approval.
What Happens to the Treatment After the Clinical Trials?
After the first three phases have been completed, the company or researcher studying the treatment submits an application to the Food and Drug Administration (FDA) asking permission to make the experimental treatment available to the public. On average, about 20 percent of treatments successfully make it through all phases of research and are approved. Put another way, for every 100 ideas for new treatments, 20 eventually become standards of care.
On average the approval process takes about a year, but it can take several more. Some drugs are approved in a matter of months. These drugs are considered priority drugs - drugs that provide a significant advance in treatment for a life-threatening condition. The FDA's goal is to rule on these drugs no more than six months after they've been submitted for approval.
To Learn More About Clinical Trials
To learn more about your rights as a clinical trial participant:
To find a clinical trial:
To learn more about National Cancer Institute Sponsored Research Groups: