1. How to Find and Access Clinical Trials New Treatments, No Tricks A Seminar on Minority Participation in Clinical Trials June 15, 2010

2. Before You Start: Understanding Clinical Trials (What they are, Why they are important, The risks and benefits to participating) July 15, 20102

3. What Is a Clinical Trial? Clinical trials are an important part of the research process. A clinical trial is a research study Conducted with people As compared to laboratory research or animal studies (pre- clinical) To answer specific health or health-related questions That follows a study plan called a Protocol The majority of clinical trials conducted in the U.S. test new drugs. Source: National Medical Association July 15, 20103

4. Stages in the Development of Drugs Laboratory Research  Animal Studies  Clinical Trials July 15, 20104 Source: National Medical Association

5. What is a Protocol? Clinical trials are conducted according to a plan called a Protocol. A Protocol is a study plan that describes, among other things: The types of individuals that may or may not enter the study Age, gender, the type and stage of a disease, previous treatment history, and other medical conditions The schedule of services and procedures, drugs, dosages, and length of the study How the outcomes of the study will be measured July 15, 20105

6. Why Are Clinical Trials Important? Clinical trials are an important step in discovering new treatments for conditions and diseases As well as new ways to detect, diagnose, and reduce the risk of disease. Clinical trials help determine what does and does not work in people. Many people have been helped and are alive because other people (you!) chose to participate in a trial that resulted in a new, more effective treatment. July 15, 20106

7. Do Many People Take Part in Clinical Trials? Few people participate. One 2008 study showed that less than 1% of the American population participate in clinical trials. In addition, women, older people, minorities, disabled individuals, and rural populations have been underrepresented in clinical trials for decades. July 15, 20107 Why?

8. Who Sponsors Clinical Trials? Clinical trials are sponsored or funded by a variety of organizations: Federal agencies National Institutes of Health (NIH) Department of Defense (DoD) Department of Veteran’s Affairs (VA) Pharmaceutical companies Device companies Foundations A type of nonprofit corporation that may either donate funds and/or provide support to other organizations for charitable activities. July 15, 20108

9. What Types of Clinical Trials are There? The NIH organizes trials into five (5) types: 1. Prevention Looks for better ways to prevent disease in people who have never had the disease or prevent the disease from returning 2. Screening Tests the best ways to detect certain diseases or health conditions 3. Diagnostic Tests the best ways to detect certain diseases or health conditions July 15, 20109

10. What Types of Clinical Trials are There? The NIH five (5) types continued: 4. Treatment Tries to find better tests and procedures for diagnosing a particular disease or condition 5. Quality of Life Studies options for improving the quality of life for people who have certain medical conditions July 15, 201010

11. What are the Phases of Clinical Trials of New Drugs? Phase I Researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate safety, determine safe dose range, and identify side effects. Phase II The experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety. July 15, 201011

12. What are the Phases of Clinical Trials of New Drugs? Phase III The experimental drug or treatment is given to a large group of people (1,000-3,000) to confirm effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely. July 15, 201012

13. What are the Phases of Clinical Trials of New Drugs? Phase IV Post marketing studies (drug has been approved by the Food and Drug Administration) that gather additional information, including the drug’s risks, benefits, and optimal use. Source: ClinicalTrials.gov July 15, 201013

14. Potential Benefits of Taking Part Opportunity to get actively involved in your health care Potentially receive free health screenings and exams Gain access to potentially new research treatments Access to expert medical care for the condition being studied and close monitoring Since investigators are often specialists in study area Have the chance to help others and improve medical care July 15, 201014

15. Potential Risks of Taking Part Unpleasant and serious side effects Treatment may not be effective for all study subjects Protocol may require more time and attention than standard treatment May need to visit the study site on a regular basis More treatments than normal For some trials, there may be expenses not covered by the sponsor of the trial. Possible costs are discussed during the informed consent process and documented in the informed consent form. July 15, 201015

16. Finding a Clinical Trial: The Next Steps July 15, 201016

17. Finding Clinical Trials Your healthcare provider Remember – your best starting point is your doctor and other members of your healthcare team They can help you determine whether a clinical trial is a good option. The newspaper, radio, television Local universities, health providers, and hospitals Examples - The University of Tennessee Health Science Center, Methodist Foundation, The Regional Medical Center at Memphis, UT Medical Group, Inc. The Internet July 15, 201017

18. Using the Internet to Find A Clinical Trial ClinicalTrials.gov ClinicalTrials.gov is maintained by the National Library of Medicine and is a service of the National Institutes of Health. It is a registry of federally and privately supported clinical trials conducted in the United States and around the world. Internet address: http://clinicaltrials.gov Will provide you with information on a trial such as: The trial’s purpose Who may participate Locations Phone numbers for more details July 15, 201018

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23. Using the Internet to Find a Clinical Trial CenterWatch CenterWatch is a third-party clinical trial website that is not operated by funders, sponsors, or organizations carrying out clinical trials. It offers information on clinical trials, news and analysis, study grants, and trial listings to professions and patients. Internet address: http://www.centerwatch.com/ Can search clinical trials by: Medical condition Therapeutic area July 15, 201023

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29. Using the Internet to Find a Clinical Trial Industry-Sponsored Sites If you are aware of a treatment and know the company that manufactures it, locate the Website of the company. Try a search engine like Google Some of largest pharmaceutical companies: Johnson & Johnson - http://www.jnj.com/ Pfizer - http://www.pfizer.com/ Roche – http://www.roche.com/ GlaxoSmithKline - http://www.gsk.com/ Find company’s customer service telephone number When you call, ask to speak to the company’s clinical trial department Tell them that you are looking for a trial that you might be eligible to join July 15, 201029

30. After Finding a Clinical Trial: Whether or Not to Participate July 15, 201030

31. Make a List of Potential Trials Trial objective Make sure the trial’s main objective matches your goals Eligibility criteria Does your diagnosis and current overall state of health match the eligibility criteria? This may tell you whether you qualify for the trial. Trial location Is the location of the trial manageable for you? Is parking available? Look carefully at how often you will be required to go to the trial site and decide how far and often you are willing to travel. Study duration Will the time commitment work for you and your family? July 15, 201031

32. Contact the Clinical Trial Team Contact the team directly Through your research, you should have the name and telephone number of someone you can contact for more information. Ask to speak with the study coordinator A study coordinator works under the direction of the principal investigator and is responsible for the organization and coordination of a research project. For example - Screening, recruiting, and enrolling participants, consenting, collecting data, and scheduling The study coordinator can answer questions about a trial. The trial coordinator may also be responsible for determining whether you are likely eligible to join the trial. July 15, 201032

33. Questions To Ask 1. Is the trial still open? 2. What is the purpose of the trial? 3. Am I eligible for the trial? 4. Who is sponsoring the trial? 5. How long will the trial last? 6. What kind of tests, procedures, or treatments will be performed? How many? How often? July 15, 201033

34. Questions to Ask 9. What costs will I be responsible for? Service and/or procedures 10. Will I be paid for childcare, travel, and other expenses? 11. What are the risks and benefits? How do the risks and benefits compare to my current treatment? 12. Can I leave the trial at anytime? 13. How will participating in the trial affect my everyday life? July 15, 201034

35. After Finding a Clinical Trial: Final Steps July 15, 201035

36. Discuss and Review Options It is helpful to talk with your doctor, family members, and/or friends before joining a trial. Be sure to know all the various treatment options and understand possible risks and benefits You may decide that joining a trial is your best option or you may decide not to join. It is your choice July 15, 201036

37. Schedule an Appointment If you decide that the clinical trial is the best option for you, schedule an appointment with the study coordinator. July 15, 201037

38. Learn as Much as You Can about the Clinical Trial Before Deciding to Participate July 15, 201038

39. For More Information National Institutes of Health An agency of the Department of Health and Human Services and is the primary Federal agency for conducting and supporting medical research. http://www.nih.gov/ ClinicalTrials.gov can be accessed through the National Institutes of Health website Food and Drug Administration An agency of the Department of Health and Human Services responsible for protecting and promoting public health through the regulation and supervision of many areas, including pharmaceutical drugs and medical devices. http://www.fda.gov/ July 15, 201039

40. How to Find and Access Clinical Trials Alisa M. Firehock, MHA, FACHE Executive Director Tennessee Clinical Trials Network alisa.firehock@tctn.org 901-448-6977 office 901-448-1512 fax Please visit the Tennessee Clinical Trials website at: http://www.tctn.org