Clinical trials are research studies that help find ways to improve health care. Researchers do cancer clinical trials to look for better ways to treat cancer. Each study tries to answer scientific questions and to find better ways to prevent, diagnose, or treat cancer. You may be able to help with the research by enrolling in a clinical trial.
There are several types of trials.
Most research that involves the testing of a new drug moves ahead in a series of steps called phases. There are usually 3 phases:
A phase I trial usually enrolls just a small number of people.
An important thing to know about cancer clinical trials is that they do not use placebos. Placebos are "blanks," that is, pills or injections that do not contain any medicine. Sometimes people worry that participating in a cancer clinical trial will mean that they will not be given any treatment. In cancer research new drugs and treatments are compared with known treatments, not with a lack of treatment.
If you decide to take part in a trial, you will work with a research team. Team members may include doctors and other healthcare providers. They will give you specific instructions about the study, provide your care, and check your health carefully during the study.
Participating in a trial may mean that you have more tests and doctor visits than you would if you were not in the study. To make the trial results as reliable as possible, you must follow the research team's instructions. That means carefully following the schedule for all doctor visits and tests, taking medicines on time, and completing logs or answering questionnaires.
Some of the possible benefits are:
Possible risks include:
The US government has a system for protecting people who take part in these studies. Before a government-funded clinical trial can start, the trial plan must be approved. During the trial, review committees make sure that the plan is being followed and participants are being protected from any unusual risks or side effects.
Regulations require researchers to tell you about a study's treatments, tests, and possible benefits and risks before you decide to join the trial. This process is called informed consent.
After a phase I or phase II trial is completed, the researchers look carefully at the data collected during the trial and decide whether to:
When the analysis of a trial is complete, the researchers will share the results with the medical community and the public. In most cases, the results of trials are published in scientific or medical journals.
Each study has guidelines for who can take part, called eligibility criteria. Eligibility criteria for a treatment trial might be:
To find out if you are eligible for a particular study, talk to your healthcare provider or the provider in charge of enrolling people in the study.
Only you can make the decision about whether or not to participate in a clinical trial. Before you make your decision:
When you talk with your healthcare provider, some of the questions you may want to ask are:
For more information, contact:
