What Are Clinical Trials?
Clinical trials are research studies involving people.
Who Organizes a Clinical Trial?
Organizations or individuals looking for better treatments for cancer or new ways to prevent or detect cancer may sponsor clinical trials. Individual doctors at cancer centers or other medical institutions can also conduct trials.
How Are Clinical Trials Conducted?
Clinical trials testing new treatments are carried out in phases.
Phase I — Is the Treatment Safe?
As the first step in testing the research, doctors gather information about the side effects of the treatment and decide on the safe dose. Only a few patients in a few places take part in a Phase I trial.
Phase II — Does the Treatment Work?
In this step, doctors test the treatment to see how well it works. Most of the time, fewer than 100 patients are involved in Phase II trials.
Phase III — Is the Treatment Better?
Phase III trials compare the new treatment against the current standard therapy and randomly assign patients into one of the two groups. Many people from all over the country take part in these trials.
Phase IV — Are There Better Ways to Use the Treatment?
In this final step, treatments are tested to make sure they are safe and work well over a long period of time. This phase most often occurs once the new treatment has been approved for standard use. Anywhere from several hundred to several thousand people are enrolled in a Phase IV trial.
Where Are Clinical Trials Conducted?
Clinical trials are available through oncologists everywhere — not just in major cities or in large hospitals.
What Are the Types of Clinical Trials?
These trials test new approaches that doctors believe may reduce your chance of developing cancer. Most involve healthy people who have not had cancer. Some studies are conducted with people who have had cancer in the past to try to find ways to prevent second cancers.
Since cancer is often easier to cure when it is found early, screening trials test methods to better detect cancer, especially in the early stages. These studies also help find out whether finding cancer before it causes symptoms will lessen a patient's chances of dying from the disease.
Diagnostic trials help answer whether or not there are new approaches that could be used to find certain types of cancer and at an earlier stage.
The purpose of these trials is to find out if a new treatment or technique is better than the standard treatment. This can include new approaches to radiation therapy, new drugs, vaccines and different combinations of treatment.
Supportive Care/Quality of Life
These studies explore ways to improve the comfort and quality of life of people with cancer or survivors. These trials also study ways to better combat the side effects of some treatments.
These are generally done with another clinical trial and focus on how genetic makeup can affect detection, diagnosis or response to cancer treatment.
Who Can Participate in a Clinical Trial?
Each clinical trial calls for certain criteria that a patient must meet to be included in that trial.
It’s important to remember that clinical trials are completely voluntary. Patients can leave a trial at any time.
What Is Informed Consent?
Informed consent is the process by which you agree to take part in a clinical trial after receiving information about the purpose of the study, the treatment that will be given, the tests that will be taken, and the risks and benefits of treatment.
What Are the Benefits?
Although there are risks with any treatment, there are also many benefits of taking part in a clinical trial. For example:
What Are the Risks?
Before taking part in a clinical trial, talk to your doctor about some of the risks involved with your treatment. For example:
Questions to Ask Your Doctor
Before joining a clinical trial, you may want to ask your doctor questions about the study and your treatment.
How Can I Join a Clinical Trial?
If you are interested in joining a clinical trial, talk to your doctor. He or she can help you find out if a trial is right for you.
Who Pays for a Clinical Trial?
Before taking part in a clinical trial, it's important to ask what your costs will be.
Facts About Clinical Trials