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Clinical Trials and Research

Learn about clinical trials, phases, study structure, ethics, informed consent, and benefits. Discover how trials help HIV patients.

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Clinical Trials and Research

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  1. Clinical Trials and Research A Guide for Community Advisory Board Members Participant Manual

  2. PACTG Global Training Initiative This teaching tool was developed by the François-Xavier Bagnoud Center at the University of Medicine and Dentistry of New Jersey, with the support of the Pediatric AIDS Clinical Trials Group. Excerpts from this publication may be freely reproduced or adapted with acknowledgement of the source, provided the material reproduced is for non-profit distribution. Clinical Trials & Research

  3. Glossary • Clinical Trial: A way to test new medications • Eligibility: Deciding if a person is qualified to join a clinical trial • Phases: Stages • Placebo: Dummy tablet • Protocol: A written plan for the clinical trial • Study sample: People to be studied in the clinical trial • Volunteers: People willing to join the trial Clinical Trials & Research

  4. What is a Clinical Trial? Identify a health question. Develop a plan. Enroll volunteers and follow the plan. Study the information collected. Share the results with others. Improve treatment. Clinical Trials & Research

  5. Medicine “A” Medicine “B” Example of a Research Question • Is Medicine A more effective for preventing mother-to-child transmission thanMedicine B? Clinical Trials & Research

  6. Phases of Clinical Trials Clinical Trials & Research

  7. Structure of a Simple Trial Comparing Two Treatments Medicine “A” Result “A” Study Sample R Result “B” Medicine “B” Clinical Trials & Research R= Random assignment of patients to a treatment arm

  8. Randomisation Control Group Investigational Group Clinical Trials & Research

  9. Ethics Committees • The ethics committee reviews a protocol before the study is allowed to start. Their job is to ensure that the risks of being in the study are not greater than the potential benefit. Clinical Trials & Research

  10. Informed Consent • To make informed decisions, patients need to hear and understand specific information about the research. Clinical Trials & Research

  11. Purpose Medicine to be studied Procedures and schedule Risks Potential benefits Alternatives to participation Confidentiality Informed Consent Clinical Trials & Research

  12. Informed Consent • Participation in clinical trials is always voluntary. Yes, I would like to participate. No, thank you, I’d rather not participate. Clinical Trials & Research

  13. Research Protocol Clinical Trials & Research

  14. Medicine “A” Medicine “B” Objectives: Clear and Specific Statements • Which medicine is more effective in reducing mother-to-child transmission of HIV—Medicine “A” or Medicine “B”? Clinical Trials & Research

  15. X X X Eligibility • Who may participate in this study • Who may not (X) participate in this study X Clinical Trials & Research

  16. Data Safety and Monitoring Boards (DSMB) • The job of the DSMB is to monitor the study for any problems with the safety or effectiveness of the medicines. Clinical Trials & Research

  17. Safety • A protocol must describe known risks or side effects and exactly what will be done to protect and monitor patients. Clinical Trials & Research

  18. Schedule of Events • To evaluate the effect of the medicine on their health, all patients in a trial have certain tests or procedures at regularly scheduled intervals. Clinical Trials & Research

  19. + + + + + Endpoints • An endpoint is what researchers will measure to evaluate the results of a new medicine. + Clinical Trials & Research

  20. CAB: Part of the Research Team Clinical Trials & Research

  21. The Research Team • CAB members and volunteers who join clinical trials are part of the team dedicated to finding better ways to prevent and treat HIV. Clinical Trials & Research

  22. How Have Clinical Trials Helped People with HIV? • Clinical trials are critical in the effort to find better ways to treat HIV and AIDS. Clinical Trials & Research

  23. How Have Clinical Trials Helped People with HIV? • Antiretroviral medicines can greatly reduce the chance an infant will be HIV-infected during or after birth. Clinical Trials & Research

  24. How Have Clinical Trials Helped People with HIV? • They have greatly decreased sickness and death among patients who receive antiretroviral medicine. Clinical Trials & Research

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