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Minority Recruitment and Adherence in Clinical Trials

Minority Recruitment and Adherence in Clinical Trials. Doris Browne, MD, MPH Program Director Breast and Gynecologic Cancer Research Group Division of Cancer Prevention National Cancer Institute. What Are Cancer Clinical Trials?. Research studies involving people

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Minority Recruitment and Adherence in Clinical Trials

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  1. Minority Recruitment and Adherence in Clinical Trials Doris Browne, MD, MPH Program Director Breast and Gynecologic Cancer Research Group Division of Cancer Prevention National Cancer Institute

  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

  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

  4. Why Are Cancer Clinical Trials Important? • Clinical trials translate results of basic scientific research into better ways to prevent, diagnose, or treat cancer • The more people that take part, the faster we can: • Answer critical research questions • Find better treatments and ways to prevent cancer

  5. Cancer Prevention Trials • Evaluate the effectiveness of ways to reduce the risk of cancer • Enroll healthy people at high risk for developing cancer

  6. Today’s Standard Treatment Was Yesterday’s Clinical Trial

  7. Minority Recruitment to Clinical Trials • Few minority patients and physicians participate in clinical trials • Most drugs are approved without minority participation • Using genetics to make targeted medicines • Drugs approved based on foreign data • Expectation that approved drugs will work for all (including minorities)

  8. The Past Abuses • Pre- and post- Civil War Medical Experimentation • Tuskegee Syphilis Experiments • “Student or Night Doctors”

  9. Barriers to, Benefits of, and Risks of Participation in Clinical Trials

  10. Barriers to Participation in Clinical Trials Physicians and other health providers may: • Be unaware of appropriate trials • Be unwilling to lose control of patient’s care • Believe that standard therapy is best • Believe that clinical trials are more work • Harbor concerns about the patient’s care or how the person will react to suggestion of clinical trial participation

  11. Barriers to Participation in Clinical Trials Patients may: • Be unaware of clinical trials • Lack access to trials • Fear, distrust, or be suspicious of research • Have practical or personal obstacles • Face insurance or cost problems • Be unwilling to go against their physicians’ wishes

  12. Reasons Minorities Don’t Participate in Clinical Trials • Unaware of clinical trials • No access to healthcare • The doctor didn’t recommend it • Distrust of medical research • Negative past experiences with the healthcare system • Cultural beliefs or myths • Racial and ethnic discrimination

  13. Benefits of Participation Possible benefits: • Subjects will receive, at a minimum, the best standard treatment • If the new treatment or intervention is proven to work, subjects may be among the first to benefit • Subjects have a chance to help others and improve cancer care

  14. Benefits of Minority Participation • Better targeted medicines • Access to, and experience with the newest treatments before they are available to others • Very carefully watched health • Most study treatment at no cost • Providing scientific help to others

  15. 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 subjectt • Health insurance and managed care providers do not always cover clinical trials

  16. Possible Risks & Inconveniences for Minorities • Potential or unexpected side effects • Placebo treatment • May not work for you • Unknown risks • Time; additional cost • May have to stop taking other medications • Transportation

  17. Protection of Participants • Nuremberg • National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research • Belmont Report • National Research Act

  18. Who is Watching Out for the Subject’s Interest • The National Institutes of Health • The Food and Drug Administration • The Institutional Review Board • The Clinical Investigator • Health Care Provider • Subject’s knowledge of the process

  19. Government Oversight of Safeguards for Participants • Office for Human Research Protections (OHRP) • The Common Rule • FDA Regulations

  20. Protecting Participants Before a Trial • Scientific review by sponsoring organization • Institutional review board approval • Informed consent

  21. Protecting Participants During a Clinical Trial • Institutional review boards (IRBs) • Data and safety monitoring boards (DSMBs) • Minimize risks • Ensure integrity of data • Can stop study if necessary

  22. Questions: Ask & Answered • What is the study about? • Who put the study together? • Where is the trial being conducted? • What will the patient get out of the study? • What are the risks? • How long will the study last? • What tests are involved?

  23. Questions: Ask & Answered • How will I be protected from harm? • Do I have to pay for any part of the trial? • Who should be contacted for problems or questions? • What do I have to do in this study? • What are the other options?

  24. Subject’s Decision & Rights • The decision to participate is the subject’s • Informed Consent is more than a signature - it is a process that your health care provider should walk you through • All the facts about a study must be given before the patient decides to participate • Including details about the treatments and test(s) they may receive and the benefits and risks • Patient rights should be fully explained

  25. How to Find Clinical Trials • The Internet • National Library of Medicine • http://www.ClinicalTrials.gov • Centerwatch Clinical Trials • http://www.centerwatch.com • NCI/CancerNet • http://cnetdb.nci.nih.gov/trials.html • Your healthcare provider • CIS:1-800-4-CANCER (1-800-422-6237) • Newspaper, radio, or television

  26. NCI Information Resources • NCI Web sitewww.cancer.gov • Cancer Information Service • 1-800-4-CANCER • TTY- 1-800-332-8615 • www.cancer.gov/cis : (

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