What Are Clinical Trials?
Clinical trials are research studies that involve people. They are the final step in a long process that begins with research in a lab and animal testing. Many treatments used today are the result of past clinical trials.
In cancer research, clinical trials are designed to answer questions about new ways to:
- Treat cancer
- Find and diagnose cancer
- Prevent cancer
- Manage symptoms of cancer or its treatment
These studies are designed to answer questions about new treatments or new ways of using an old treatment and how well they work. These trials test many types of treatments, such as new:
- Drugs or vaccines
- Ways to do surgery or give radiation therapy
- Combinations of treatments
Clinical Trials Follow Strict Guidelines
The guidelines that clinical trials follow clearly state who will be able to join the study and the treatment plan. Every trial has a person in charge, usually a doctor, who is called the principal investigator. The principal investigator prepares a plan for the study, called a protocol, which is like a recipe for conducting a clinical trial.
The protocol explains what the trial will do, how the study will be carried out, and why each part of the study is necessary. It includes information on:
- The reason for doing the study
- Who can join the study
- How many people are needed for the study
- Any drugs they will take, the dose, and how often
- What medical tests they will have and how often
- What information will be gathered about them
Who Can Join a Clinical Trial?
Based on the questions the research is trying to answer, each clinical trial protocol clearly states who can or cannot join the trial.
- Common criteria for entering a trial:
- Having a certain type or stage of cancer
- Having received a certain kind of therapy in the past
- Being in a certain age group
- Criteria such as these help ensure that people in the trial are as alike as possible. This way doctors can be sure that the results are due to the treatment being studied and not other factors.
These criteria also help ensure:
Some people have health problems besides cancer that could be made worse by the treatments in a study. If you are interested in joining a trial, you will receive medical tests to be sure that you are not put at increased risk.
Accurate and meaningful study results
You may not be able to join some clinical trials if you already have had another kind of treatment for your cancer. Otherwise, doctors could not be sure whether your results were due to the treatment being studied or the earlier treatment.
Randomization is a process used in some clinical trials to prevent bias. Bias occurs when a trial's results are affected by human choices or other factors not related to the treatments being tested. Randomization helps ensure that unknown factors do not affect trial results.
In a randomized clinical trial, you will be assigned by chance to either a control group or an investigational group.
Randomization is used in all phase III and some phase II trials. These trials are called randomized clinical trials. If you participate in such a trial, you will be assigned by chance to either an investigational group or a control group. Your assignment will be determined with a computer program or table of random numbers.
If you are assigned to the control group, you will get the most widely accepted treatment (standard treatment) for your cancer.
If you are assigned to the investigational group, you will get the new treatment being tested.
Comparing these groups to each other often clearly shows which treatment is more effective or has fewer side effects. If you are thinking about joining a randomized clinical trial, you need to understand that you have an equal chance to be assigned to either one of the groups. The doctor does not choose the group for you.
Will I get a placebo?
A placebo is designed to look like the medicine being tested, but it is not active. Placebos are almost never used in cancer treatment trials. In some cases, a study may compare standard treatment plus a new treatment, to standard treatment plus a placebo. You will be told if the study uses a placebo.