Clinical trials test new medical approaches in patients with cancer, and are important to developing new treatments for cancer. The standard treatments that patients receive today were developed and tested in clinical trials.
What are the different phases of clinical trials?
Treatments progress through trial phases before they become standard treatments.
- Phase I trials test how safe a new treatment is.
- Phase II trials test how well, or if, a treatment works.
These first two phases together are considered 'early phase' clinical trials. Norris Cotton Cancer Center has an Early Phase Clinical Trials Program focused on bringing these important and innovative clinical trials to our patients.
If treatments show promise during these early phases, then they go through more phases to continue testing safety and effectiveness with more patients.
Who can participate in a clinical trial?
There are many factors that define who may participate in a clinical trial. To answer a specific question about a new approach to cancer care, certain things are kept the same for all participants, such as:
- Medical history
- Stage of cancer
- Type of cancer
These common characteristics help researchers achieve accurate and meaningful results and may also minimize the risk of a person's condition becoming worse by participating in the study.
Why should I participate in a clinical trial?
Clinical trials help advance treatment in different ways. They may help determine:
- If a drug is effective in treating cancer
- If a drug that treats one kind of cancer will be effective in treating another kind of cancer
- What kind of diet or activities will help patients feel better
- What we can do to prevent cancer
What are the risks in participating in a clinical trial?
A new treatment or medical approach becomes a clinical trial because it has shown strong promise in laboratory studies. Results in the clinic may be different than in laboratory studies.
The new therapy may not be better than the standard treatment patients receive outside of the clinical trial, or it may have unexpected or different side effects. Clinical trials help highlight these differences. If the study compares different treatments, participants are often randomly assigned to one treatment or the other.
Participants do not get to choose which treatment they receive. Patients should also consider the costs of trial participation and determine what costs will be covered by their insurance or the study sponsor. Speak with your cancer doctor or the clinical trial team for more information about how services will be billed.
Are clinical trials safe?
Clinical trials have a strict set of policies and practices they must follow. Every clinical trial has a plan, called a protocol, which describes what will happen in the study and why it is necessary.
Before a clinical trial begins, local scientific review and human subject protection committees review the protocol and only approve it if the clinical trial meets all the applicable requirements and standards. Additionally, the U.S. Food and Drug Administration (FDA) reviews all trials that involve Investigational New Drugs and Devices. These groups can stop a clinical trial that is not following the protocol or is causing unexpected harm to participants.
Finally, participants can choose to leave a study at any time—before the clinical trial starts or at any time over the course of the trial.
What is informed consent and why is it important?
The process of informed consent gives patients the information they need to decide if they want to participate in a clinical trial. In the informed consent process, a doctor or a research nurse will explain the purpose of the study, the tests and procedures involved, and the known possible risks and benefits.
During the informed consent process, you are encouraged to ask questions to be sure you understand all aspects of participation in the clinical trial. If you agree to participate, you will be asked to sign an informed consent document. You also may be asked to sign a new consent form as new benefits, risks, or side effects are discovered.
How can I get more information about clinical trials?
The following organizations provide general information about clinical trials online:
You can talk to your provider to find out if a clinical trial at Norris Cotton Cancer Center is right for you. We also have cancer research nurses who can answer your questions about clinical trials. They can be reached by calling (800) 639-6918 or emailing email@example.com.
In addition, you can search this website for clinical trials currently being conducted at Norris Cotton Cancer Center. You can search by cancer type, principal investigator, study number, or word or phrase.