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Should You Join a Clinical Trial?

Clinical trials, or research studies, are studies of new or experimental treatments in patients, and they are a critical component in expanding treatment options for people with all types of cancer.
Clinical trials rely on patient volunteers to investigate different ways to treat disease, using investigational drugs — also called study drugs — and experimental ways of giving drugs to determine if they are safe and effective.

Since all new therapies must be evaluated through clinical trials, the greater the number of people who participate, the faster emerging anti-cancer therapies can be brought to market. These trials also provide patients with access to therapies that are still in development, but might offer specific advantages for their particular type of cancer.


In addition, here is a downloadable list of questions to ask your doctor about clinical trials:
       
Questions to Ask Your Doctor about Clinical Trials
  
Note: This tool and more are also available in the Patient Resources section.

Why Are Clinical Trials Important?
Clinical trials contribute to the overall knowledge and progress made in developing new therapies. If you agree to participate in a clinical trial, you may benefit from the research study, while receiving the best current standard treatment as well.

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Here are some frequently asked questions about clinical trials:
 
Why Are Clinical Trials Important?
How Do Clinical Trials Work?
What Is a Trial Like for Patients?
Why Do Cancer Patients Choose
  to Participate in Clinical Trials?
How Do I Know If I Should
  Participate in a Clinical 
  Trial?
Are There Risks Involved in
  Participating?
How Do I Learn about Specific
  Clinical Trials?


How Do Clinical Trials Work?
Clinical trials are structured into four phases:
  
• In Phase I clinical trials, researchers test a study drug in a small group of people (20 to 80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
• In Phase II clinical trials, the study drug is tested in a larger group of people (100 to 300) to measure its effectiveness and further evaluate its safety.
• In Phase III clinical trials, the study drug is tested in large groups of people (1,000 to 3,000) to confirm its effectiveness, monitor side effects, compare it to approved standard treatments, and collect information that will allow the study drug to be used safely.
• In Phase IV clinical trials, the drug is tested after it has been marketed to collect information about its effect in various populations and about any side effects associated with long-term use.
 
 
What Is a Trial Like for Patients?
If you are eligible and agree to participate, you are assigned randomly either to a group that receives the current standard treatment for your cancer or a group that receives the current standard treatment and the study drug. If no current standard treatment exists, one trial group receives the study drug and one receives a placebo — for example, a sugar pill — that is similar to the study drug but contains no active ingredient.

During the trial, a healthcare team monitors all of the patients and gives you specific instructions and information about the trial and about additional tests and doctor visits that might be required along with any related costs.

Throughout the trial, patients come first. If your disease does not improve or you have intolerable side effects, you and your doctor can decide to stop participating in the trial and go back to other treatment options. If you decide to leave the trial, your decision will be respected, and it will have no effect on your future treatment plan.

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Why Do Cancer Patients Choose to Participate in Clinical Trials?
Some hope to assist in finding a cure or seek a longer life or a way to feel better. Others find that the current standard therapies are not working well for their cancer and want to be among the first to participate in a research study and receive an investigational drug.

Whatever the reason, participation could make a difference in a patient’s future as well as in the lives of future cancer patients.

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How Do I Know If I Should Participate in a Clinical Trial?
The decision to participate in a clinical trial is one that only you can make, with the help of your doctor and the people close to you. Before you decide to join the trial, you will learn the key facts about the trial in a process called “informed consent.” Your doctor will explain the purpose and requirements of the study, including any potential drawbacks and benefits. If you agree to join the trial, you will be asked to review and sign a form that outlines the study's objectives, risks, and financial details prior to participating.

If the investigational drug is proven to be effective, you may be among the first to benefit. In addition, through your participation in a research study, you will be helping future cancer patients.

Back to Top 
 
Are There Risks Involved in Participating?
Because clinical trials are research studies, study drugs may be no better than current standard drugs or treatments. In addition, you may experience side effects that are worse than those of current standard drugs and treatments. Also, your health insurance company may not cover all of the costs associated with a clinical trial, some of which could be serious or life-threatening. You should discuss all of these factors thoroughly with your doctor and those close to you before deciding whether to participate in a clinical trial.

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How Do I Learn about Specific Clinical Trials?
Clinical trials may be available right in your own community. Ask your physician for trial information or use the US Oncology trial search tool to find a current US Oncology trial in your region.

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How Do Clinical Trials Work?
Clinical trials are structured into four phases: 

• In Phase I clinical trials, researchers test a study drug in a small group of people (20 to 80) for the first time to evaluate its safety, determine a safe dosage range and identify side effects.
• In Phase II clinical trials, the study drug is tested in a larger group of people (100 to 300) to measure its effectiveness and further evaluate its safety.
• In Phase III clinical trials, the study drug is tested in large groups of people (1,000 to 3,000) to confirm its effectiveness, monitor side effects, compare it to approved standard treatments and collect information that will allow the study drug to be used safely.
• In Phase IV clinical trials, the drug is tested after it has been marketed to collect information about its effect in various populations and about any side effects associated with long-term use.

Back to Top

What Is a Trial Like for Patients?
If you are eligible and agree to participate, you are assigned randomly either to a group that receives the current standard treatment for your cancer or a group that receives the current standard treatment and the study drug. If no current standard treatment exists, one trial group receives the study drug and one receives a placebo — for example, a sugar pill — that is similar to the study drug but contains no active ingredient.

During the trial, a healthcare team monitors all of the patients and gives you specific instructions and information about the trial and about additional tests and doctor visits that might be required along with any related costs.

Throughout the trial, patients come first. If your disease does not improve or you have intolerable side effects, you and your doctor can decide to stop participating in the trial and go back to other treatment options. If you decide to leave the trial, your decision will be respected, and it will have no effect on your future treatment plan.

Back to Top 
 
Why Do Cancer Patients Choose to Participate in Clinical Trials?
Some hope to assist in finding a cure or seek a longer life or a way to feel better. Others find that the current standard therapies are not working well for their cancer and want to be among the first to participate in a research study and receive an investigational drug.

Whatever the reason, participation could make a difference in a patient’s future as well as in the lives of future cancer patients.

Back to Top 
 
How Do I Know If I Should Participate in a Clinical Trial?
The decision to participate in a clinical trial is one that only you can make, with the help of your doctor and the people close to you. Before you decide to join the trial, you will learn the key facts about the trial in a process called “informed consent.” Your doctor will explain the purpose and requirements of the study, including any potential drawbacks and benefits. If you agree to join the trial, you will be asked to review and sign a form that outlines the study's objectives, risks and financial details prior to participating.

If the investigational drug is proven to be effective, you may be among the first to benefit. In addition, through your participation in a research study, you will be helping future cancer patients.

Back to Top 
 
Are There Risks Involved in Participating?
Because clinical trials are research studies, study drugs may be no better than current standard drugs or treatments. In addition, you may experience side effects that are worse than those of current standard drugs and treatments. Also, your health insurance company may not cover all of the costs associated with a clinical trial, some of which could be serious or life-threatening. You should discuss all of these factors thoroughly with your doctor and those close to you before deciding whether to participate in a clinical trial.

Back to Top
   
How Do I Learn about Specific Clinical Trials?
Clinical trials may be available right in your own community. Ask your physician for trial information or use the US Oncology Research trial search tool to find a current US Oncology Research trial in your region.

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