Clinical Trials
You may have had to make a lot of decisions since you've been told you have cancer. One of the most important decisions you will make is deciding which treatment is best for you. You may have heard about clinical trials being done for your type of cancer. Or maybe someone on your health care team has mentioned a clinical trial to you. Clinical trials are one way to get state-of-the art cancer care. Still, they are not right for everyone.
Here we will give you a brief review of clinical trials. Talking to your health care team, your family, and your friends can help you make the best treatment choice for you.
What are clinical trials?
Clinical trials are carefully controlled research studies that are done with patients. These studies test whether a new treatment is safe and how well it works in patients, or they may test new ways to diagnose or prevent a disease. Clinical trials have led to many advances in cancer prevention, diagnosis, and treatment.
The purpose of clinical trials
Clinical trials are done to get a closer look at promising new treatments or procedures in patients. A clinical trial is only done when there is good reason to believe that the treatment, test, or procedure being studied may be better than the one used now. Treatments used in clinical trials are often found to have real benefits and may go on to become tomorrow's standard treatment.
Clinical trials can focus on many things, such as:
* new uses of drugs that are already approved by the US Food and Drug Administration (FDA)
* new drugs that have not yet been approved by the FDA
* non-drug treatments (such as radiation therapy)
* medical procedures (such as types of surgery)
* herbs and vitamins
* tools to improve the ways medicines or diagnostic tests are used
* medicines or procedures to relieve symptoms or improve comfort
* combinations of treatments and procedures
Researchers conduct studies of new treatments to try to answer the following questions:
* Is the treatment helpful?
* What's the best way to give it?
* Does it work better than other treatments already available?
* What side effects does the treatment cause?
* Are there more or fewer side effects than the standard treatment used now?
* Do the benefits outweigh the side effects?
* In which patients is the treatment most likely to be helpful?
Phases of clinical trials
There are 4 phases of clinical trials, which are numbered I, II, III, and IV. We will use the example of testing a new cancer treatment drug to look at what each phase is like.
Phase I clinical trials: The purpose of a phase I study is to find the best way to give a new treatment safely to patients. The cancer care team closely watches patients for any harmful side effects.
For phase I studies, the drug has already been tested in lab and animal studies, but the side effects in patients are not fully known. Doctors start by giving very low doses of the drug to the first patients and increase the doses for later groups of patients until side effects appear or the desired effect is seen. Doctors are hoping to help patients, but the main purpose of a phase I trial is to test the safety of the drug.
Phase I clinical trials are often done in small groups of people with different cancers that have not responded to standard treatment, or that keep coming back (recurring) after treatment. If a drug is found to be reasonably safe in phase I studies, it can be tested in a phase II clinical trial.
Phase II clinical trials: These studies are designed to see if the drug works. Patients are given the best dose as determined from phase I studies. They are closely watched for an effect on the cancer. The cancer care team also looks for side effects.
Phase II trials are often done in larger groups of patients with a specific cancer type that has not responded to standard treatment. If a drug is found to be effective in phase II studies, it can be tested in a phase III clinical trial.
Phase III clinical trials: Phase III studies involve large numbers of patients -- most often those who have just been diagnosed with a specific type of cancer. Phase III clinical trials may enroll thousands of patients.
Often, these studies are randomized. This means that patients are randomly put in one of two (or more) groups. One group (called the control group) gets the standard, most accepted treatment. Another group (or more than one group) will get the new treatment being studied. All patients in phase III studies are closely watched. The study will be stopped early if the side effects of the new treatment are too severe or if one group has much better results than the others.
Phase III clinical trials are usually needed before the FDA will approve a treatment for use by the general public.
Phase IV clinical trials: Once a drug has been approved by the FDA and is available for all patients, it is still studied in other clinical trials (sometimes referred to as phase IV studies). This way more can be learned about short-term and long-term side effects and safety as the drug is used in larger numbers of patients with many types of diseases. Doctors can also learn more about how well the drug works, and if it might be helpful when used in other ways (such as in combination with other treatments).
What it will be like to be in a clinical trial
If you are in a clinical trial, you will have a team of experts taking care of you and watching your progress very carefully. Depending on the phase of the clinical trial, you may receive more attention (such as having more doctor visits and lab tests) than you would if you were treated outside of a clinical trial. Clinical trials are specially designed to pay close attention to you.
However, there are some risks. No one involved in the study knows in advance whether the treatment will work or exactly what side effects will occur. That is what the study is designed to find out. While most side effects go away in time, some may be long-lasting or even life threatening. Keep in mind, though, that even standard treatments have side effects. Depending on many factors, you may decide to enter (enroll in) a clinical trial.
Deciding to enter a clinical trial
If you would like to take part in a clinical trial, you should begin by asking your doctor if your clinic or hospital conducts clinical trials. There are requirements you must meet to take part in any clinical trial. But whether or not you enter (enroll in) a clinical trial is completely up to you.
Your doctors and nurses will explain the study to you in detail. They will go over the possible risks and benefits and give you a form to read and sign. The form says that you understand the clinical trial and want to take part in it. This process is known as giving your informed consent. Even after reading and signing the form and after the clinical trial begins, you are free to leave the study at any time, for any reason. Taking part in a clinical trial does not keep you from getting any other medical care you may need.
To find out more about clinical trials, talk to your cancer care team. Here are some questions you might ask:
* Is there a clinical trial that I could take part in?
* What is the purpose of the study?
* What kinds of tests and treatments does the study involve?
* What does this treatment do? Has it been used before?
* Will I know which treatment I receive?
* What is likely to happen in my case with, or without, this new treatment?
* What are my other choices and their pros and cons?
* How could the study affect my daily life?
* What side effects can I expect from the study? Can the side effects be controlled?
* Will I have to stay in the hospital? If so, how often and for how long?
* Will the study cost me anything? Will any of the treatment be free?
* If I am harmed as a result of the research, what treatment would I be entitled to?
* What type of long-term follow-up care is part of the study?
* Has the treatment been used to treat other types of cancers?
How can I find out more about clinical trials that might be right for me?
The American Cancer Society offers a clinical trials matching service for patients, their family, and friends. You can reach this service at 1-800-303-5691 or on our Web site at http://clinicaltrials.cancer.org.
Based on the information you give about your cancer type, stage, and previous treatments, this service can put together a list of clinical trials that match your medical needs. The service will also ask where you live and whether you are willing to travel so that it can look for a treatment center that you can get to.
You can also get a list of current clinical trials by calling the National Cancer Institute's Cancer Information Service toll free at 1-800-4-CANCER (1-800-422-6237) or by visiting the NCI clinical trials Web site at www.cancer.gov/clinicaltrials.
For even more information on clinical trials, see our document Clinical Trials: What You Need to Know. You can have it sent to you by calling 1-800-ACS-2345.
You may have had to make a lot of decisions since you've been told you have cancer. One of the most important decisions you will make is deciding which treatment is best for you. You may have heard about clinical trials being done for your type of cancer. Or maybe someone on your health care team has mentioned a clinical trial to you. Clinical trials are one way to get state-of-the art cancer care. Still, they are not right for everyone.
Here we will give you a brief review of clinical trials. Talking to your health care team, your family, and your friends can help you make the best treatment choice for you.
What are clinical trials?
Clinical trials are carefully controlled research studies that are done with patients. These studies test whether a new treatment is safe and how well it works in patients, or they may test new ways to diagnose or prevent a disease. Clinical trials have led to many advances in cancer prevention, diagnosis, and treatment.
The purpose of clinical trials
Clinical trials are done to get a closer look at promising new treatments or procedures in patients. A clinical trial is only done when there is good reason to believe that the treatment, test, or procedure being studied may be better than the one used now. Treatments used in clinical trials are often found to have real benefits and may go on to become tomorrow's standard treatment.
Clinical trials can focus on many things, such as:
* new uses of drugs that are already approved by the US Food and Drug Administration (FDA)
* new drugs that have not yet been approved by the FDA
* non-drug treatments (such as radiation therapy)
* medical procedures (such as types of surgery)
* herbs and vitamins
* tools to improve the ways medicines or diagnostic tests are used
* medicines or procedures to relieve symptoms or improve comfort
* combinations of treatments and procedures
Researchers conduct studies of new treatments to try to answer the following questions:
* Is the treatment helpful?
* What's the best way to give it?
* Does it work better than other treatments already available?
* What side effects does the treatment cause?
* Are there more or fewer side effects than the standard treatment used now?
* Do the benefits outweigh the side effects?
* In which patients is the treatment most likely to be helpful?
Phases of clinical trials
There are 4 phases of clinical trials, which are numbered I, II, III, and IV. We will use the example of testing a new cancer treatment drug to look at what each phase is like.
Phase I clinical trials: The purpose of a phase I study is to find the best way to give a new treatment safely to patients. The cancer care team closely watches patients for any harmful side effects.
For phase I studies, the drug has already been tested in lab and animal studies, but the side effects in patients are not fully known. Doctors start by giving very low doses of the drug to the first patients and increase the doses for later groups of patients until side effects appear or the desired effect is seen. Doctors are hoping to help patients, but the main purpose of a phase I trial is to test the safety of the drug.
Phase I clinical trials are often done in small groups of people with different cancers that have not responded to standard treatment, or that keep coming back (recurring) after treatment. If a drug is found to be reasonably safe in phase I studies, it can be tested in a phase II clinical trial.
Phase II clinical trials: These studies are designed to see if the drug works. Patients are given the best dose as determined from phase I studies. They are closely watched for an effect on the cancer. The cancer care team also looks for side effects.
Phase II trials are often done in larger groups of patients with a specific cancer type that has not responded to standard treatment. If a drug is found to be effective in phase II studies, it can be tested in a phase III clinical trial.
Phase III clinical trials: Phase III studies involve large numbers of patients -- most often those who have just been diagnosed with a specific type of cancer. Phase III clinical trials may enroll thousands of patients.
Often, these studies are randomized. This means that patients are randomly put in one of two (or more) groups. One group (called the control group) gets the standard, most accepted treatment. Another group (or more than one group) will get the new treatment being studied. All patients in phase III studies are closely watched. The study will be stopped early if the side effects of the new treatment are too severe or if one group has much better results than the others.
Phase III clinical trials are usually needed before the FDA will approve a treatment for use by the general public.
Phase IV clinical trials: Once a drug has been approved by the FDA and is available for all patients, it is still studied in other clinical trials (sometimes referred to as phase IV studies). This way more can be learned about short-term and long-term side effects and safety as the drug is used in larger numbers of patients with many types of diseases. Doctors can also learn more about how well the drug works, and if it might be helpful when used in other ways (such as in combination with other treatments).
What it will be like to be in a clinical trial
If you are in a clinical trial, you will have a team of experts taking care of you and watching your progress very carefully. Depending on the phase of the clinical trial, you may receive more attention (such as having more doctor visits and lab tests) than you would if you were treated outside of a clinical trial. Clinical trials are specially designed to pay close attention to you.
However, there are some risks. No one involved in the study knows in advance whether the treatment will work or exactly what side effects will occur. That is what the study is designed to find out. While most side effects go away in time, some may be long-lasting or even life threatening. Keep in mind, though, that even standard treatments have side effects. Depending on many factors, you may decide to enter (enroll in) a clinical trial.
Deciding to enter a clinical trial
If you would like to take part in a clinical trial, you should begin by asking your doctor if your clinic or hospital conducts clinical trials. There are requirements you must meet to take part in any clinical trial. But whether or not you enter (enroll in) a clinical trial is completely up to you.
Your doctors and nurses will explain the study to you in detail. They will go over the possible risks and benefits and give you a form to read and sign. The form says that you understand the clinical trial and want to take part in it. This process is known as giving your informed consent. Even after reading and signing the form and after the clinical trial begins, you are free to leave the study at any time, for any reason. Taking part in a clinical trial does not keep you from getting any other medical care you may need.
To find out more about clinical trials, talk to your cancer care team. Here are some questions you might ask:
* Is there a clinical trial that I could take part in?
* What is the purpose of the study?
* What kinds of tests and treatments does the study involve?
* What does this treatment do? Has it been used before?
* Will I know which treatment I receive?
* What is likely to happen in my case with, or without, this new treatment?
* What are my other choices and their pros and cons?
* How could the study affect my daily life?
* What side effects can I expect from the study? Can the side effects be controlled?
* Will I have to stay in the hospital? If so, how often and for how long?
* Will the study cost me anything? Will any of the treatment be free?
* If I am harmed as a result of the research, what treatment would I be entitled to?
* What type of long-term follow-up care is part of the study?
* Has the treatment been used to treat other types of cancers?
How can I find out more about clinical trials that might be right for me?
The American Cancer Society offers a clinical trials matching service for patients, their family, and friends. You can reach this service at 1-800-303-5691 or on our Web site at http://clinicaltrials.cancer.org.
Based on the information you give about your cancer type, stage, and previous treatments, this service can put together a list of clinical trials that match your medical needs. The service will also ask where you live and whether you are willing to travel so that it can look for a treatment center that you can get to.
You can also get a list of current clinical trials by calling the National Cancer Institute's Cancer Information Service toll free at 1-800-4-CANCER (1-800-422-6237) or by visiting the NCI clinical trials Web site at www.cancer.gov/clinicaltrials.
For even more information on clinical trials, see our document Clinical Trials: What You Need to Know. You can have it sent to you by calling 1-800-ACS-2345.
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