Clinical trials for colon cancer and rectal cancer, the types and FAQ
Types of Clinical Trials
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Work with high risk individuals to test interventions that might reduce risk of developing cancer. These interventions might include drugs or lifestyle changes. People in these studies are often followed for several years to determine the long-term effects on prevention.
Aim to determine the most effective method and frequency for screening the general public in order to better detect cancer, especially in the early stages. These studies also help uncover if finding cancer before it causes symptoms improves chances of survival. These trials involve people who do not have any symptoms of cancer.
Study procedures that could be used to identify cancer more accurately and at an earlier stage. Diagnostic trials usually include people who have signs or symptoms of cancer.
Conducted with people who have cancer. They are designed in phases to answer specific questions about, and evaluate the effectiveness of, a new treatment or a new way of using a standard treatment. These clinical trials test many types of cancer treatments, including new drugs, vaccines, approaches to surgery or radiation therapy and combinations of treatments.
Supportive Care Trials
Test new options for dealing with side effects of cancer and treatment. These options might include medicines to address chemo side effects, nutritional interventions or psychosocial options such as support groups or one-on-one support. These trials may be aimed at patients or caregivers needing help in coping with the disease.
Frequently Asked Questions
Clinical trials test cutting edge approaches for treating or diagnosing cancer. They give scientists important information about the effectiveness of new, unexplored treatments, leading to the development of more promising options for patients.
What is a clinical trial?
Clinical trials are the first point of testing new treatments in humans and the last point of testing treatments prior to FDA approval or disapproval. Prior to clinical trials, experimental methods are tested, generally for years, first in the lab and then on animals. Clinical trials first test these new methods outside the lab in a real-life environment to see if it is safe for humans, then determine if it works as well as or better than the existing approaches.
How do cancer clinical trials differ from other clinical trials?
Cancer trials differ slightly from other clinical trials because cancer trials ensure all participants get either the standard treatment (the already approved or accepted treatment) or the experimental treatment. Placebos are not given in cancer trials.
What are the risks?
Potential risks in a clinical trial include financial risks, potential insurance complications, physical risks and the possibility of unexpected side effects. Before being deterred by cost, keep in mind that the research sponsor generally pays for costs of the experimental drugs and tests that are specific to the study.
Are clinical trials safe?
“Informed consent” protects trial participants by ensuring investigators fully inform their patients about the benefits and risks of participation. The safeguarding procedures of every trial are carefully reviewed by the FDA and the participating cancer center’s Institutional Review Board.
As an experimental drug moves through the clinical trial process, safety, effectiveness and side effects are compared to the standard accepted treatment. Patients are watched closely and if any issues arise, the patient leaves the trial and resumes standard treatment. If a treatment shows negative results for most patients, it is discontinued. If a treatment is benefiting most patients, others in the trial will be switched to that beneficial treatment. Patients can leave the trial at any time for any reason and may resume the standard treatment or explore other clinical trials.
Why is participating in a clinical trial important?
Bottom line: More patients in trials can mean faster development of new and promising options. Patients participating in clinical trials are helping all cancer patients by moving research forward.
Are clinical trials only for people going through treatment?
No, clinical trials can be for prevention, screening, diagnostic, treatment and supportive care. Learn more about the types of clinical trials by visiting this page.
Best Available Standard Treatment
Also known as the control treatment, the best available standard treatment is the current treatment that has shown the best results in past trials. The standard is evolving as clinical trials identify new treatments with better results.
Phases for Cancer Trials
A phase for clinical trials defines the type of testing happening at a specific point; it is not necessarily related to the patient’s stage of cancer. Clinical trials for cancer-fighting drugs are conducted in three phases:
- Phase I trials test dosage levels and the best way to apply the treatment (pills or injections, frequency); side effects are monitored and used to determine the appropriate dosage levels for Phase II testing
- Phase II trials examine the effectiveness against selected types of cancers
- Phase III trials systematically compare the outcomes — the effectiveness and side effects — of the best available standard treatment and the experimental treatment(s)
A protocol is a blueprint for the trial which describes how the trial will proceed, what types of patients will be eligible, the number of patients required, the type of care participants will receive and so on. All protocols are reviewed by the sponsoring group (like the NCI or FDA) and the Institutional Review Board (IRB) of the institution where the research is being conducted to ensure patients are fully informed and risks are minimized.
Clinical trials can include multiple “arms.” Each arm is a study group of patients receiving a specific treatment or combination of treatments that is being compared to other treatment arms as well as to the control arm. The “control arm” is the best available standard treatment.
Institutional Review Board (IRB)
Each research institution has an Institutional Review Board. The IRB, which includes non-medical and medical professionals, reviews all protocols for patient safety. The board also reviews the consent information given to patients who are thinking about participating in the trial, to make sure it is written in clear, understandable language.
The principle of informed consent means that patients have the right to be fully informed about a trial before agreeing to participate in that trial. The patient receives complete trial information, including treatment specifics, potential risks, benefits and side effects. The patient must sign an “informed consent form” before he or she is allowed to participate. If the protocol changes during the trial, the informed consent process is repeated.
National Cancer Institute (NCI)
NCI is a federal agency that oversees the nation’s cancer research program. Many clinical trials are funded by and/or conducted with NCI. There are also NCI Cancer Centers around the country; these are clinical and research facilities that meet NCI criteria and standards for cancer research.
US Food and Drug Administration (FDA)
The FDA’s role is to oversee the pharmaceutical research conducted by drug companies, university research centers and physicians to make sure federal regulations governing this research are followed. The FDA oversees the testing and subsequent approval of any new pharmaceutical candidate.