How You Can Be an Advocate for Clinical Trials in Your Community

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Objectives

Define cancer clinical trials, including how they work and their risks and benefits

Identify common patient barriers to participation in cancer clinical trials

Discuss barriers faced by health-care providers to making referrals, and explore ways in which these barriers can be overcome

Name at least two sources of additional information about clinical trials

Identify at least two key messages about cancer clinical trials that you can share with peers

Cancer Clinical Trials

Key Things for Advocates to Know

Why Should We Care About Cancer Clinical Trials?We all benefit from finding better ways to treat or prevent cancer

Some Quotes to Consider

Cancer Clinical Trials

How They Work

Cancer Clinical Trials…

Are research studies to find better ways to prevent, detect, or treat cancer

Help doctors find ways to improve cancer care

Who Benefits?

Less than 5% of all adults with cancer participate in clinical trials

And, even fewer among racial and ethnic minority and low-income groups

The results of many trials help change the way cancer care is provided for everyone, but…

Some Are More Likely to Die from Cancer than Others

* Hispanic is not mutually exclusive from whites, African Americans, Asian/Pacific Islanders, and American Indians/Alaska Natives.SEER Program, 1975–2002, Division of Cancer Control and Population Sciences, National Cancer Institute (2005)

There’s a Lot of Myths About Cancer Research

Only the researchers benefit!

You get a sugar

pill.

Not the way for people like

me to get good care!

It’s a treatment of last resort!! They treat

you like a “guinea

pig”

Do Patients Get a Placebo?

In cancer treatment trials, people get treated for their cancerNo one gets a placebo (sugar pill)

instead of appropriate treatment Placebos may be used in prevention

trials

Reasons Why People Don’t Participate in Clinical Trials

Don’t trust “the system” Believe the myths Aren’t aware Have a different cultural

perspective Don’t qualify Don’t have insurance Face other problems

More Reasons Why People Don’t Participate in Clinical Trials

Community doctors (primary care)

Aren’t aware

Don’t refer patients to clinical trials

Participating doctors (oncologists)

May not ask all patients who are eligible

There Are Different Types of Cancer Clinical Trials Treatment

Prevention

Diagnostic

Screening/early detection

Quality of life

Three Phases of Clinical Trials Phase I: is it safe? Phase II: does it work? Phase III: is it better than what is used

now to treat this cancer?

1. Preclinical research

2. File Investigational New Drug Application with FDA

6. File New Drug Application or Biologics License Application with FDA

3. Phase I

4. Phase II

5. Phase III

7. Review by FDA and approval

8. Postmarketing surveillance

In Many Clinical Trials, Participants Are Placed into Different Groups

One group gets the most widely accepted treatment

The other group(s) gets the new treatment being tested, which doctors hope will be better

All participants in the trial have an equal chance to be assigned to one of two or more groups:

Randomization

There Are Benefits …

In most trials, patients get at least the best treatment available

Patients are closely followed by doctors and nurses

If the new treatment is proven to work, patients may be among the first to benefit

… And There Are Risks

Even if a new treatment has benefits, it may not work for all patients

New treatments are not always better than what is already being used to treat the cancer

There may be unexpected side effects

Other Concerns

Clinical trials may have added costs that aren’t covered by insurance

Not everyone is able to join a clinical trial

There Are Laws Protecting Patients’ SafetyFederal regulations

ensure that people are told about the benefits, risks, and purpose of research before they agree to participate

We Have Protections Today Because of Abuses in the Past

In German concentration camps

In the Tuskegee Syphilis Study

With retarded children and with the elderly

20th Century abuses of human rights…

Protections Today: Informed Consent Process

The purpose of the trial What will happen during

the trial The risks and potential

benefits Their individual rights

Participants must be told about…

Protections Today: Three Other Ways

Scientific review Institutional

Review Boards (IRBs)

Data Safety Monitoring Boards(DSMBs)

How Would You Respond?

Patients never get a placebo (sugar pill) instead of appropriate treatment

They have rights that are protected under the law

They also have the right to leave a clinical trial at any time, for any reason

Aren't people who join cancer

clinical trials just "guinea

pigs" for research?

How Would You Respond?

Clinical trials are not only for those with the most advanced disease

Clinical trials can be a good treatment option for many types of cancer patients

They are not the “last resort” for patients who have no other treatment choices

Cancer treatment

clinical trials are the

treatment of “last resort.”

Serving as a Cancer Clinical Trials Advocate

in Your Community: What You Can Do

Spreading the Word

One on one Community

activities

Levels of Cancer Clinical Trials: Awareness and Acceptance

Not aware of cancer clinical trials

General “awareness” of cancer clinical trials

» Looking for options for treatment, not aware

» Exploring clinical trials

» Actively participating in a cancer clinical trial

» Past participant of a cancer clinical trial

General public Cancer patient

Things You Can Share with Anyone About Cancer Clinical Trials

Cancer clinical trials are studies with people looking at ways to better prevent, diagnose, and treat cancer

The only way we can make progress in fighting cancer is through clinical trials

Most people with cancer aren’t told that clinical trials are a quality treatment option

More Things You Can Share with Anyone About Cancer Clinical Trials Taking part is voluntary, and participants

can leave the clinical trial at any time There are federal laws that protect the

rights of research participants Clinical trials are not appropriate for

everyone

4 Things You Can Share About Cancer Clinical Trials with Every Patient

Ask your doctor about all your treatment options, including clinical trials

Patients on cancer clinical trials receive high quality care

All patients get treated for their cancer No one gets a placebo (sugar pill)

instead of appropriate treatment

Ask, Assess, Assist

Offer appropriate information and support about cancer clinical trials

Adapted from Tobacco Cessation 5. A Model Clinical Practice Guideline: Treating Tobacco Use and Dependence.

Ask

» Assess where they stand in terms of awareness level to reply appropriately

» Ask open questions to help understand someone’s current knowledge and attitudes about clinical trials

Assess

Assist

How Would You Respond? Julie, a fellow co-worker, joins you at the

office cafeteria for lunch. As you both sit down, Julie picks up the local newspaper on the table and runs across an article reporting findings from a recent breast cancer treatment trial. She turns to you, commenting ,“I’d never want to be on one of these trials if I had cancer. That’s only for people as a last resort.”

Three Things You Can Do

Practice talking about cancer clinical trials with family and friends

Look for recent examples about clinical trials in the media as a means of initiating a conversation

Share what you’ve learned today with your fellow cancer advocates and how you can make cancer clinical trials education more of a priority within the services you provide

Thank you!