Presenter Instructions

1. Presenter Instructions • This slide presentation is designed to assist you with your education efforts about clinical trials. Each slide includes a note section to help guide the presenter. • To print slides with notes: • File, print, at the “print what box” select handouts, check pure black and white, OK (40 pages) • Please complete the Evaluation Form

2. Why Clinical Research is Important to Persons with HIV/AIDS Developed for the AIDS Clinical Trials Group by the Recruitment and Retention Subcommittee of the Patient Care Committee

3. What Does Research Do Why Participate? Lessons From the Past Protections for Study Volunteers How Trials Work Involving the Community in the Research Effort We will cover…….

4. What Does Research do? • Finds answers to difficult scientific or health questions • Finds out whether and how procedures, tests, or investigational medicines work • Determines how gender, age and race affect the effectiveness of investigational treatments • Uses nonexperimental observation – watching and measuring but not involving drug or procedure

5. Why HIV Clinical Trials? • Is the investigational treatment safe? • Do treatments work the same in women? In men? In children? • What about side effects?

6. I Found the Cure! If it sounds too good to be true . . . IT PROBABLY IS!

7. False cures “Compound Q” A Chinese herb which was believed to have “anti-HIV” properties and was used by underground buyers in the late 1980’s and early 1990’s

8. The Pressure Is On • Because HIV is life threatening and the epidemic continues to grow, there is great pressure to complete studies quickly and efficiently • Carefully designed, scientific studies set the standards for patient care

9. Advantages of Participation HEALTH • Frequent monitoring of health status and early detection of complications • Help with taking medicines correctly • Early access to investigational medicines and tests • Some studies show that people who participate in clinical trials do better than those who do not

10. Advantages of Participation OTHER • A chance to be part of the solution • Free lab work and some trial medicines • Personalized, friendly, confidential care • Partnership with primary care provider

11. Relationship With Primary Care Provider • Every volunteer must have a primary care provider. • The primary care provider will be kept informed of the status of the study and receive laboratory results with the volunteer’s consent.

12. Possible Concerns of Participation • Time and commitment • Discomfort from medical procedures • Side effects • Reminder of HIV-positive status

13. Possible Concerns of Participation (cont’d) • Feeling of being a guinea pig • Lack of treatment flexibility • May limit future treatment options • Privacy

14. Lessons Learned From the Past Tuskegee Experiment Thalidomide

15. The Tuskegee Experiment A 40 year government study of the effects of untreated syphilis in Black men in Tuskegee, Alabama, in which participants were offered free treatment and follow-up for “Bad Blood.” In fact, they were not treated, even when a cure became available in the 1940’s.

16. The Thalidomide Disaster A drug already approved for use in Europe and Canada (1957-1962) was later found to cause severe birth defects in the children of women who took it during pregnancy. Some of these birth defects included the absence of arms and legs in the babies born to these women.

17. Questions & Concerns Question: Could these kinds of things happen again?

18. Answer There are now several safety nets in place to protect volunteers. • Data Safety and Monitoring Board • Institutional Review Board

19. Is locally based Includes community representatives Ensures: A proper consent process Benefit potential outweighs risk Research is ethical Institutional Review Board (IRB)

20. Protecting the Rightsof Volunteers Question: How can the rights of volunteers be protected?

21. Protecting the Rightsof Volunteers Answer: • Carefully Read the informed consent document • Ask questions • Ask to speak with a study volunteer • Join the Community Advisory Board • The choice is the volunteer’s participation is always voluntary

22. What Is a Clinical Trial? A clinical trial is a planned experiment that involves volunteers and is designed to determine the most appropriate treatment for future patients with a given medical condition.

23. Phases of Clinical Trials • An investigational medication must go through different phases of clinical trials before Food and Drug Administration approval. • Laboratory studies first, then animal studies, then human studies

24. Clinical Trial Phases PHASE I PHASE II PHASE III Question Is the treatment safe? Does the treatment What are the long - work? term results in lots of people? Riskiest Moderate risk Lowest risk Risk - First trials in – – More humans. Performed in Some safety information about HIV+ and HIV – information about the safety and volunteers. Used to drug is known. effectiveness is determine doses. known. Shortest Medium Length Longest Length – A few – – May last weeks to a few Usually about a year. . for two to three years months. Number of Few participants About one hundred At least several participants hundred participants. participants Adapted from “Clinical Trials Explained - Community Initiative on AIDS (CRIA)

25. Phase I Clinical Trials • Look at drug safety and toxicity • Measure how the drug is absorbed and how much is found in the blood • Require small numbers of volunteers • Are a short duration • Close monitoring of volunteers

26. Phase II Clinical Trials • Continue to evaluate drug safety • Determine the dose that works the best with the least side effects • Involve a larger number of volunteers

27. Phase III Clinical Trials • Continue to evaluate drug safety • Compare investigational drug with current standard treatment • Monitor long-term effectiveness • Involve larger numbers of volunteers

28. Studies where a new drug is compared to a pill that has no harmful, nor helpful effects. The pill will look, feel, taste and smell like an actual medication Double-blinded: Neither the medical provider nor the study volunteer knows who is taking a placebo or not. In ACTG studies only the site pharmacist knows. Placebo-Controlled Trials

29. Assigned by chance, as if by a toss of the coin, to one or more “arms” (groups) of the study. Randomization

30. Access to Clinical Trials All HIV-positive individuals are welcome to be screened at the local Clinical Research Site clinic for possible participation.

31. Eligibility Criteria Every study has its own set of eligibility criteria • Inclusion Criteria - What it takes to get in • Exclusion Criteria - What may keep a person out

32. Who Can Participate?

33. Participation of Special Populations • Pregnant Women • Children • Prisoners • Other

34. Every Clinical Research Site should have an established CAB whose members reflect: Demographics of the HIV epidemic: Age, gender Racial and ethnic populations Multiple educational/literacy/language levels The various routes of HIV transmission: Sexual transmission (Gay/Bi/Straight) Injection drug users and their partners Mom to child; exposure to blood products Community Advisory Boards (CAB)

35. Role of the Community Advisory Board (CAB) • Members of the CAB assist the local Clinical Research Site in selection and implementation of trials • CABs are the liaison to the community • CABs help people with HIV better understand clinical trials • CABs improve access to trials so that everyone may benefit from the trial findings

36. JOIN! Community Advisory Board • (Place the Date, Time, and Location of meetings here) • Learn from researchers about investigational studies and the latest results in HIV treatment • Serve as a liaison between (name of Center) and HIV-positive communities

37. Clinical Trials Information Contact for clinical trials: 1-800-TRIALS-A (1-800-874-2572) www.actis.org

38. Local Clinical Research Site Contact Information • (Add site-specific info here • Address and phone numbers) • Name of Nurse Coordinator • Name of Principal Investigator • Others

39. What Does Research Do Why Participate Lessons From the Past Protections for Study Volunteers How Trials Work Involving the Community in the Research Effort Summary

40. The Importance Of Scientific Research A life is not important except in the impact it has on other lives… Jackie Robinson