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

2. Terms and Conditions of Use All uses of these training materials are subject to the copyright and trademark notices contained in the Training Materials and the Terms and Conditions for Use of Copyrighted Materials posted on ENACCT’s Web site, www.enacct.org

3. 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

4. Cancer Clinical Trials Key Things for Advocates to Know

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

6. Some Quotes to Consider

7. Cancer Clinical Trials How They Work

8. Cancer Clinical Trials…  Are research studies to find better ways to prevent, detect, or treat cancer  Help doctors find ways to improve cancer care

9. 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…

10. 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)

11. 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”

12. Do Patients Get a Placebo?  In cancer treatment trials, people get treated for their cancer  No one gets a placebo (sugar pill) instead of appropriate treatment  Placebos may be used in prevention trials

13. 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

14. 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

15. There Are Different Types of Cancer Clinical Trials  Treatment  Prevention  Diagnostic  Screening/early detection  Quality of life

16. 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

17. 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:

18. Randomization

19. 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

20. … 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

21. Other Concerns  Clinical trials may have added costs that aren’t covered by insurance  Not everyone is able to join a clinical trial

22. There Are Laws Protecting Patients’ Safety  Federal regulations ensure that people are told about the benefits, risks, and purpose of research before they agree to participate

23. 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 20 th Century abuses of human rights…

24. 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…

25. Protections Today: Three Other Ways  Scientific review  Institutional Review Boards (IRBs)  Data Safety Monitoring Boards (DSMBs)

26. 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?

27. 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.”

28. Serving as a Cancer Clinical Trials Advocate in Your Community: What You Can Do

29. Spreading the Word  One on one  Community activities

30. 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

31. 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

32. 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

33. 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

34. 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

35. 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.”

36. 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

37. Thank you!