1. Cancer Clinical Trials:
What they are and why Minorities need to be involved
Whether you are a cancer survivor, someone who is touched by cancer, or someone who works with people with cancer, this presentation will help answer some of the most important questions you may have about clinical trials.  
The presentation will include a discussion about:
Why cancer clinical trials are important
How clinical trials work
How clinical trials advance cancer care
How participants are protected
Some of the barriers to participating in clinical trials
And finally, I’ll talk about ways you can find clinical trials in your community.
Sara Horton, M.D.
Assistant Professor, Division Hematology/Oncology
Director of Clinical Trials
Howard University Cancer Center

2. What Are Cancer Clinical Trials?
Research studies involving people
Try to answer scientific questions and find better ways to prevent, diagnose, or treat cancer
Clinical trials are research studies involving people. Clinical trials are the final step in a long research process that includes preliminary laboratory research and animal testing.
Clinical trials try to answer specific scientific questions to find better ways to prevent, detect, or treat diseases, or to improve care for people with diseases.
In cancer research, a clinical trial is designed to show how a certain anticancer approach—for instance, a promising drug, a new surgical procedure, a new diagnostic test, or a possible way to prevent cancer—affects the people who receive it.

3. Why Are Cancer Clinical Trials Important?
Cancer affects all of us
Each year in the U.S.A:
More than half a million people are expected to die of cancer — more than 1,500 people a day
1 of 4 deaths is from cancer
More than 1 million new cancer cases are expected to be diagnosed
It is important to understand that cancer affects us all, whether we have it, care about someone who does, or worry about getting it in the future.
Each year in the United States:*
About half a million people are expected to 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.

4. Why Are Cancer Clinical Trials Important?
Clinical trials translate results of basic scientific research into better ways to prevent, diagnose, or treat cancer
It is important to understand what clinical trials do to fight cancer:
·         Clinical trials translate results of basic scientific research into better ways to prevent, diagnose, or treat cancer.
·         Clinical trials contribute to knowledge and progress against cancer. Many of today’s most effective cancer treatments are based on previous study results. Because of progress made through clinical trials, many people treated for cancer are now living longer.
·         The more people that participate in clinical trials, the faster we can answer the critical research questions that will lead us to better treatment and prevention options for all cancers.
     
The more people that take part, the faster we can:
Answer critical research questions
Find better treatments and ways to prevent cancer

5. Do Many People Participate in Cancer Clinical Trials?
Only 3 percent of U.S. adults with cancer participate in clinical trials
Fewer than 5 percent of U.S. adults with cancer participate in clinical trials—far fewer than the number needed to answer the most pressing cancer questions quickly.
We’ll talk more later about why so few participate.

6. Types of Cancer Clinical Trials
Treatment trials
Prevention trials
Early-detection trials/screening trials
Diagnostic trials
Quality-of-life studies/supportive care studies
There are at least 5 types of cancer clinical trials:
1. Treatment trials seek to find out:
·         What new treatment approaches can help people who have cancer
·         What is the most effective treatment for people who have cancer
2. Prevention trials seek to find out what approaches can prevent a specific type of cancer from developing in people who have not previously had cancer
3. Early-detection/screening trials seek to discover new ways of finding cancer in people before they have any cancer symptoms
4. Diagnostic trials seek to find out how new tests or procedures can better identify cancer in people when we think it is there
5. Quality-of-life/supportive care trials seek to find out what kinds of new approaches can improve the comfort and quality of life of people who have cancer

7. Clinical Trial Phases at a Glance
Study Question: Is the new treatment (or new use of a treatment) better than current practice?
Participants: Varies; many receive 1st-line treatment through phase 3 trials
n = 100s to 1000s
Phase 2
Study Questions: Does the treatment do what it is supposed to do for a particular cancer? How does the treatment affect the human body?
Participants: People with few, if any, treatment options
n = <100
Phase 1
Study Questions: How does the treatment affect the human body? How should the treatment be given? What dosage is safe?
Participants: People with no other treatment options
n = 15–30
Reference: National Cancer Institute (2002a)

8. Randomization
Participants have an equal chance to be assigned to one of two or more groups:
One gets the most widely accepted treatment (standard treatment)
The other gets the new treatment being tested, which researchers hope and have reason to believe will be better than standard treatment
Explain slide

9. Cancer Treatment Clinical Trials and Minority Accrual:
Facts and Myths

10. Disparities in Cancer Morbidity and Mortality
African Americans and medically underserved groups are more likely to1-7—
Be diagnosed with and die from preventable cancers
Be diagnosed with late-stage disease for cancers that are detectable at an early stage
Receive either no treatment or treatment that does not meet current standards of care
Die of cancers that are generally curable
References: 1Shavers VL, Brown ML (2002); 2Tammemagi CM (2007); 3Edwards BK, et al (2005); 4Clegg LX, et al. (2002); 5Bach PB, et al. (2004); 6Jemal A, et al. (2004); 7Gross CP, et al. (2008).

11. Myth 1
Clinical trials have nothing to do with me or my medical condition

12. Yesterdays Trials Are Today’s Treatments
Standard treatment options today are based on the results of past clinical trials, resulting in—
Changes in clinical practice
Decreasing morbidity and mortality
Additional treatment options
Improved quality of life for people diagnosed with cancer

13. Improved Treatments = Better Survival Rates
Reference: American Cancer Society (2009)

14. Unequal Benefits
Reference: American Cancer Society (2009)

15. Participation in Clinical Trials
About 20% of cancer patients are medically eligible for a clinical trial1; however—
Trial participation among adult cancer patients remains at about 2.5–3%2‒4
This rate is even lower among people of color and the medically underserved5‒7
References: 1U.S. Department of Health and Human Services (2004); 2Sateren et al. (2002); 3Christian and Trimble (2003); 4National Cancer Institute (2002b); 5Brawley (2000); 6Murthy, Krumholz, and Gross (2004); 7Stewart et al. (2007)

16. Clinical Trial Enrollment by Race and Ethnicity1
Reference: 1National Patient Advocate Foundation (2006).

17. Most Patients do not want to participate in clinical trials
Myth 2
Most Patients do not want to participate in clinical trials

18. Your Recommendation is Key
A physician’s recommendation is often the primary factor influencing patients’ decisions to enroll in a trial1, 2; however—
Only 2% of PCPs routinely discuss oncology clinical trials; 41% prefer to leave these discussions to oncologists3
37% of PCPs are unaware of local clinical trials that might be available for their patients3
References: 1Comis et al. (2000); 2Comis et al. (2003); 3Crosson (2001)

19. Willing, But Not Invited
Most patients would consider a clinical trial if their doctors recommended they do so1
Only 2% of PCPs routinely discuss oncology clinical trials; 41% prefer to leave these discussions to oncologists3
37% of PCPs are unaware of local clinical trials that might be available for their patients3
Sources: 1Harris Interactive (2002); 2Comis et al. (2000); 3Comis et al. (2003); 4Sateren et al (2002); 5Simon & Du (2004)

20. Willing, But Not Invited
All who are eligible are not offered the opportunity to participate by their treating physician
15% or fewer of all cancer patients are ever told about the option of receiving treatment through a clinical trial2, 3
People from minority groups even less likely to be offered participation4, 5
Sources: 1Harris Interactive (2002); 2Comis et al. (2000); 3Comis et al. (2003); 4Sateren et al (2002); 5Simon & Du (2004)

21. A Commonly Held Belief
Many believe that minorities are not interested in participating in research
A recent meta-analysis found that minorities are—
As willing to participate in health research as whites
Less likely to be invited to participate
Reference: Wendler et al. (2005)

22. Myth 3
Clinical trials are only for people who have run out of other treatment options

23. Clinical Trial Phases at a Glance
Study Question: Is the new treatment (or new use of a treatment) better than current practice?
Participants: Varies; many receive 1st-line treatment through phase 3 trials
n = 100s to 1000s
Phase 2
Study Questions: Does the treatment do what it is supposed to do for a particular cancer? How does the treatment affect the human body?
Participants: People with few, if any, treatment options
n = <100
Phase 1
Study Questions: How does the treatment affect the human body? How should the treatment be given? What dosage is safe?
Participants: People with no other treatment options
n = 15–30
Reference: National Cancer Institute (2002a)

24. Myth 4
Patients will be treated like “guinea pigs” if they participate in a clinical trial

25. Past Research Abuses
There have, unfortunately, been past abuses in patient protection
German Concentration Camps
Tuskegee Syphilis Study
Willowbrook Institution
Jewish Chronic Disease Hospital

26. Patient Protection
Federal regulations ensure that people are told about the benefits, risks, and purpose of research before they agree to participate
Although we now have strong safeguards for protecting those who participate in research, these protections have resulted from notorious abuses of human rights in the past.
The first formal statement of protection for individuals in research emerged from the Nuremberg trial in Germany where Nazi scientists and physicians who conducted experiments on World War II concentration camp victims were convicted. The Nuremberg Code outlined broad concepts for the protection of human subjects and forms the basis of today’s international code of ethics for the conduct of research.
In the United States, several controversial research studies alerted us to the critical need for protection for those participating in clinical trials. None of these studies sought to inform the participants about the research or gain their consent for participating.
·         From 1932 to 1972, the infamous Tuskegee Syphilis Study followed poor African American men with syphilis but did not treat them. During the study, the men were offered free medical care and were told that they would be treated for “bad blood.”
·         In the 1960s, two other research studies received major public attention. The first was a series of experiments with mentally retarded children; another involved debilitated elderly participants.
In response to these tragedies, regulations and policies were developed to ensure that people are told about the benefits, risks, and purpose of research for which they volunteer.

27. How Are Patients’ Rights Protected?
Informed consent
Scientific review
Institutional review boards (IRBs)
Data safety and monitoring boards
Participant rights and safety are protected in four main ways.

28. Use of Placebos is Rare in Cancer Treatment Clinical Trials
No patient receives a placebo instead of appropriate treatment
In Phase 3 randomized studies, patients receive either the standard treatment or the new treatment being tested
In earlier phase studies, all patients receive the same agent

29. Risks of Participation
Possible risks:
New treatments or interventions under study are not always better than, or even as good as, standard care
Even if a new treatment has benefits, it may not work for every patient
Health insurance and managed care providers do not always cover clinical trials
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 listed here.

30. Benefits of Participation
Possible benefits:
Patients will receive, at a minimum, the best standard treatment
Patients are closely monitored
If the new treatment or intervention is proven to work, patients may be among the first to benefit
Patients have a chance to help others and improve cancer care
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 listed here.

31. Why Do So Few Cancer Patients Participate in Clinical Trials?
Sometimes patients:
Don’t know about clinical trials
Don’t have access to trials
May be afraid or suspicious of research
Can’t afford to participate
May not want to go against physician’s wishes
Many people with cancer do not participate in clinical trials. Common barriers include:
Lack of awareness
Lack of access
Fear, distrust, or suspicion of research
Financial and personal concerns

32. NCI Information Resources
NCI Web site
Clinical Trials Information
Cancer Information Service
CANCER
NCI’s Web site, provides access to NCI’s clinical trial registry, which contains more than 1,800 ongoing clinical trials, with information about studies around the world. All clinical trials undergo review prior to inclusion.
Although no single resource lists every cancer clinical trial being conducted in the United States and abroad, NCI’s registry is the most comprehensive, and contains information about trials sponsored by NCI, the pharmaceutical industry, and some international groups.
You can narrow your search by looking at stage of disease, phase of trial, treatment modality, and geographic location—so it is possible for us to locate trials going on here in our community.
(You may want to mention local information sources for clinical trials in your community.)
Another resource is the CIS toll-free telephone service (1–800–4–CANCER). Through this service, callers speak with knowledgeable, caring staff who are experienced at explaining medical information in terms the public can easily understand. CIS information specialists answer calls in English and Spanish. They also answer calls from the deaf and hard of hearing through the toll-free TTY number (1–800–332–8615) . CIS staff have access to comprehensive, accurate information from the NCI on a range of cancer topics, including the most recent advances in cancer treatment. They take as much time as each caller needs, provide thorough and personalized attention, and keep all calls confidential. Calls are answered 9:00 a.m. to 4:30 p.m. local time, Monday through Friday.
The CIS also provides live, online assistance to users of NCI Web sites through LiveHelp, an instant messaging service that is available from 9:00 a.m. to 5:00 p.m. Eastern time, Monday through Friday. Through LiveHelp, information specialists provide answers to questions about cancer and help in navigating NCI Web sites.
The CIS also provides recorded information 24 hours a day, 7 days a week, through 1–800–4–CANCER. Callers can select option 4 to hear recorded information at any time.