# Presentation: 075464

## Cancer Clinical Trials:

- The Way We Make Progress Against Cancer

**Notes:**
Today I’m going to talk about cancer clinical trials, and why they are important for all of us.
I’m also going to review a little about:
 Different types of trials and how they work 
 How patients are protected
 Pros and cons of participating in clinical trials

Cancer affects everyone (you may want to ask for a show of hands to illustrate this point): 
 How many people know someone who has had cancer? 
 How many people are worried about someone they love getting cancer?

Each year in the United States:*
 About half a million people die of cancer—more than 1,500 people a day. It is the second leading cause of death, exceeded only by heart disease. 
 More than 1 million people are diagnosed with cancer. 

How many people find this surprising?

* American Cancer Society. (2001). Cancer facts and figures. Atlanta, GA.

## What Are Cancer Clinical Trials?

- Research studies to find better ways to prevent, detect, or treat cancer
- Help doctors find ways to improve cancer care

**Notes:**
Cancer clinical trials are research studies involving people. 

Each study tries to answer scientific questions and find better ways to prevent, diagnose, or treat cancer. 

Clinical trials contribute to knowledge about and progress against cancer.

## Why Are Cancer Clinical Trials Important?

- Why Are Cancer Clinical Trials Important?

- Most of the best cancer treatments we have today are based on what we learned from clinical trials

- People with cancer are living longer because of clinical trials

**Notes:**
Clinical trials translate results of basic scientific research into better ways to prevent, diagnose, or treat cancer.

Many of today’s most effective cancer treatments are based on previous studies done in the past. Because of progress made through clinical trials, many people treated for cancer are now living longer.

## Do Many People Take Part in  Cancer Clinical Trials?

- Few people take part
- The more people who take part, the faster we will find better ways to treat and prevent cancer

**Notes:**
We know that fewer than 5 percent of adult cancer patients in the U.S. participate in clinical trials. Why is this? 

There are many myths and fears about clinical trials. 

When people think about clinical trials, many imagine “guinea pigs”participants getting inferior treatment or a sugar pill (placebo) instead of actual medical treatment. Many people also think that clinical trials are for only the people who have no other treatment options available to them. Others are never offered the opportunity to participate.

The more people who participate in clinical trials, the faster we can answer the critical research questions that will lead us to better treatment, diagnosis, and prevention for all cancers. 

So, if more people learn about clinical trials and understand how they work, more people may be willing to participate. 

By learning the facts about clinical trials today, you can address the myths and fears, and help others who need to know this information.

## What Are the Different Types of Clinical Trials?

- Treatment
- Prevention
- Diagnostic
- Screening/early detection
- Quality of life

**Notes:**
It is important to know that there are different types of clinical trials.

Treatment trials test new treatments—like a new cancer drug, new approaches to surgery or radiation therapy, new combinations of treatments, or other new approaches.

Prevention trials test new approaches, such as medicines, vitamins, minerals, or other supplements that doctors believe may lower the risk of certain types of cancer. These trials look for the best ways to prevent cancer in people who have never had cancer.

Although I’m not going to be talking about them today, other types of trials look to find:
 The best ways to find cancer, especially in its early stages 
 Ways to improve comfort and quality of life for cancer patients

## Treatment Trials

- What new treatments can help people who have cancer?
- What is the most effective treatment for people who have cancer?

**Notes:**
Most cancer clinical trials are treatment trials. These clinical trials involve people who have cancer. 

These studies try to answer specific questions about the effectiveness of a new treatment or a new way of using an existing treatment. 

## Treatment Trials

- Many treatment trials compare two or more different approaches to treating cancer
- Participants will take either:
- The best accepted cancer treatment
- A new treatment

**Notes:**

Participants have an equal chance of being assigned to one of two or more groups receiving either:
 The best accepted treatment for the kind of cancer they have (standard treatment) 
 A new treatment that doctors have reason to believe will be better than the standard treatment

IT IS IMPORTANT TO REMEMBER that placebos—or sugar pills—are almost never used in cancer treatment trials. All patients are treated for their cancer.

But people who have cancers for which no standard treatment is available may take part in a trial that compares a new treatment with a placebo. Placebos or “sugar pills” are used only when there is no standard treatment available.

## Prevention Trials

- What approaches can prevent a specific type of cancer from developing in people who don’t have cancer?

**Notes:**
Unlike treatment trials, cancer prevention clinical trials are studies involving healthy people who are at high risk for developing cancer. These studies try to answer specific questions about and evaluate the effectiveness of ways to reduce the risk of cancer. 

## Prevention Trials

- 	Two kinds, that ask participants to either:
- 1.  Do something
- 2.  Take something

**Notes:**
There are two kinds of prevention trials:
 One kind focuses on finding out whether actions people take, such as exercising more or quitting smoking, can prevent cancer. 
The other kind focuses on finding out whether taking certain medicines, vitamins, minerals, or food supplements (or a combination of them) may lower the risk of a certain type of cancer. 

Placebos are used in prevention trials when we don’t yet have a known approach (standard agent) for cancer prevention. 

## Protecting Patients’ SafetyInformed Consent

- Before agreeing to take part, patients have the right to understand all that is involved in a clinical trial:
- Procedures and treatments
- Tests
- Possible risks and benefits

**Notes:**
Many people think that participant rights are not protected in clinical trials. They may remember past abuses of research participants, such as those that occurred during the infamous Tuskegee Syphilis Study. 

Today, Federal regulations help ensure that all Government-sponsored clinical trials are run in an ethical manner.

One of the most important ways patients are protected is through informed consent, which is required by law.

Before someone joins a clinical trial, a doctor or nurse will explain why the trial is being done, and what will happen during the trial. Potential participants can ask any questions they have about the trial.

Potential participants are also given an informed consent form to read. The informed consent form includes written details about the information that was discussed, and also describes the confidentiality of the participant’s records.

If the person decides to join the trial, he or she is asked to sign the informed consent form.

Even after participants sign the consent form, they can still change their minds, and stop at any time. They  will have the chance to discuss other treatments or care with a doctor from the trial. 

## Protecting Patients’ SafetyInstitutional Review Boards

- Committee made up of experts

**Notes:**
Each clinical trial is reviewed by a group of experts to make sure that it is going to be conducted in a safe and ethical way. This group is called an institutional review board (IRB).

IRBs are made up of people who are qualified to evaluate new and ongoing clinical trials on the basis of scientific, legal, and ethical merit. The board members determine whether the risks involved in a trial are reasonable with respect to the potential benefits. IRBs also monitor the ongoing progress of trials from beginning to end.

## Benefits of Taking Part

- Possible benefits:
- Patients will receive, at a minimum, the best standard treatment
- If the new approach is proven to work, patients may be among the first to benefit
- Patients have a chance to help others and improve cancer care

**Notes:**
Making a decision about taking part in a clinical trial is a very personal one. This is a question that only the person with cancer (or at high risk for cancer) can answer for him or herself.

Some of the possible benefits of participating in a clinical trial are:
 Participants are closely monitored for any side effects and may stop their participation at any time. 
 Participants have an opportunity to make a valuable contribution to cancer research.
 Participants have access to new anticancer approaches before they are widely available. 

## Risks of Taking Part

- Possible risks:
- Unknown side effects or other risks
- New treatment may not help every participant
- Costs

**Notes:**
While a clinical trial is a good choice for some people, there are possible risks. People need to consider these as they think about joining a trial.

Some of the possible risks of participating in a clinical trial are:
 New approaches may have side effects or risks that are unknown.  
 Even if a new treatment under study has benefits, it may not work for every participant. Even standard treatments proven effective for many people do not help everyone.
 Health insurers and managed care providers do not always cover all the care costs in a clinical trial. Participants may have to deal with the costs of travel, childcare, lost work hours, and meals.

## Where to Find Clinical Trial Information

- Where to Find Clinical Trial Information

- Your doctor or nurse
- National Cancer Institute** **
- _[www.cancer.](http://www.cancer.gov/)__[gov](http://www.cancer.gov/)_
- Cancer Information Service
- 1-800-4-CANCER
- TTY- 1-800-332-8615

**Notes:**
You can ask your health care provider about local clinical trials.

You can look on NCI’s Web site, www.cancer.gov, which has the latest information about cancer treatment, screening, prevention, genetics, supportive care, and complementary and alternative medicine, as well as a registry of cancer clinical trials.

You can call NCI’s Cancer Information Service for information on clinical trials.

NCI’s Cancer Information Service is a national information and education network for patients, the public, and health professionals. Staff can respond to calls in either English or Spanish. 

The toll-free number is 1-800-4-CANCER (1-800-422-6237). For deaf and hard of hearing callers with TTY equipment, the number is 1-800-332-8615. Hours of operation are Monday through Friday, 9:00 a.m. to 4:30 p.m., local time. Callers also have the option of listening to recorded information about cancer 24 hours a day, 7 days a week.