What is a cancer clinical trial?
Clinical trials look at new ways to prevent, detect, or treat cancer.
- New drugs, new combinations of drugs,
- New surgical methods, or
- New ways to use already proven treatments.
Who participates in a cancer clinical trial?
A health care provider identifies patients for clinical trials based on the type and stage of cancer.
If your doctor does not ask you about trials participation, you should ask if you are eligible for a trial and discuss the potential benefits and risks of participating.
Who conducts a clinical trial?
Every clinical trial has a principal investigator, a doctor who is in charge of all aspects of the trial.
All trials are monitored by an Institutional Review Board to ensure safety and protect the rights of patients.
How are participants protected?
The safety of patients participating in clinical trials is protected by the:
- Informed consent process
- Institutional Review Board (IRB)
- U.S. Food and Drug Administration.
What is informed consent?*
Informed consent is a process that includes:
- Telling (or get information in some way) about the possible risks and benefits of the treatment.
- Discussing the risks and benefits of other options, including not getting treatment
- Providing a chance to ask questions and get answers
- Giving time (if needed) to discuss the plan with family or advisors
- Sharing your decision with your doctor or treatment team.
What are the rights of patients who participate in clinical trials?
During the informed consent process, patients will be informed of rights. These include:
- Participation is voluntary. No one can force a person to participate.
- A person can withdraw at any time.
- If a person withdraws, his/her medical care will not be affected.
- Participants will be told about new findings and any changes in a study as they occur.
- Participant’s privacy is protected.
How are clinical trials carried out?
Clinical trials are completed in phases. Each phase of a trial has a different purposeand helps researchers answer scientific questions.
|Phase I Trials||Testing a new drug or treatment for the first time with a small group of people (20-80). Evaluates safety, determines how much to give, and identifies side effects.|
|Phase II Trials||Drug or treatment is given to a larger group of people (100-300). Measures its effectiveness and further evaluates its safety.|
|Phase III Trials||Drug or treatment is given to large groups of people (1,000-3,000). Confirms its effectiveness, monitors side effects, compares it to commonly used treatments, and collects information that will allow the drug or treatment to be used safely.|
|Phase IV trials||Monitors ongoing safety and effectiveness of a drug after it is approved by the U.S. Food and Drug Administration.|
What is randomization and why is it important?
To compare a new treatment to the usually given treatment in Phase III trials, participants are assigned to two groups. This process is called randomization. One group receives the standard treatment. The other group receives the new treatment. This allows researchers to compare the effectiveness.
Some people are concerned about receiving a placebo. A placebo is a pill, liquid or powder that looks like the treatment being studied, but has no effect. Most cancer related trials do NOT use placebos.
Who pays for the costs of a clinical trial?
The study sponsor often pays for the cost of new treatment, any special testing or extra doctor visits, and research costs. A patient’s medical insurance may pay for some or all of the costs, depending on the type of clinical trial. Patients should work with their doctor and insurer to make sure all costs are covered.
What happens when a trial is over?
The researchers review the data carefully before making decisions about the meanings of the findings and further testing. Clinical trials are often published in peer-reviewed journals. Once a new approach has been proven safe and replicated, then is may become a standard of care.