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August 2012

Understanding the Clinical Research Process and Principles of Clinical Research. August 2012.

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August 2012

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  1. Understanding the Clinical Research Process and Principles of Clinical Research August 2012 This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272201200009C, entitled NIAID HIV and Other Infectious Diseases Clinical Research Support Services (CRSS).

  2. Housekeeping Instructions for: Fire drills Rest rooms Messages Breaks and Lunch Smoking Remember to: • Participate in all activities • Share what you know • Ask questions Understanding the Clinical Research Process and Principles of Clinical Research

  3. Agenda Morning Agenda • Introduction • Objectives • Community Advisory Boards (CABs) • Clinical Research • Break Afternoon • Elements and Principles of Clinical Research Clinical Research Process • Break Understanding the Clinical Research Process and Principles of Clinical Research

  4. Audience Response System (ARS) Respond to questions Change an answer Responses are anonymous Question cue is a on preceding slide Ensure remote is on by pressing and holding the “On/Off” button Choose your answer Send or change your answer Please leave remotes on the tables Understanding the Clinical Research Process and Principles of Clinical Research

  5. Clinical Trial Negotiation Process Informed Consent Process Voluntary Confirmation Process Audience Response System (ARS) • What is the ongoing processby which a person voluntarily confirms his/her willingness to participate in a trial? Choose your answer Send or change your answer Understanding the Clinical Research Process and Principles of Clinical Research

  6. Audience Response System (ARS) Name one type of stakeholder that can be represented on a Community Advisory Board (CAB). Type your answer Send or change your answer Please type your answer on the key pad Understanding the Clinical Research Process and Principles of Clinical Research

  7. Introduction This workshop will help you to collaborate with those who work to find: New Human Immunodeficiency Virus (HIV)/Acquired Immunodeficiency Virus (AIDS) prevention technologies Improved AIDS treatment regimens A vaccine against HIV A cure for AIDS In this workshop you will: Understanding the Clinical Research Process and Principles of Clinical Research

  8. In this workshop you will: Understanding the Clinical Research Process and Principles of Clinical Research

  9. Case Studies Case Study 3 Niran Case Study 1 Case Study 2 Alex Case Study 4 Lina Thembi and her daughter Sarah • Your table number matches the case study to which you have been assigned. • You will be reviewing various scenarios regarding your assigned case study throughout the day. Understanding the Clinical Research Process and Principles of Clinical Research

  10. What Do You Know? Answer eight questions about clinical research. Understanding the Clinical Research Process and Principles of Clinical Research

  11. What Do You Know? • A. Researchers • The CAB acts as a point of contact between the community and _________. • B. National Institute of Allergy and Infectious Diseases (NIAID) • C. Clinical Trials Networks • D. Sponsors Understanding the Clinical Research Process and Principles of Clinical Research

  12. What Do You Know? • A. Physicians • Clinical trials are sponsored or funded by various organizations or individuals including (select all that apply): • B. Foundations and voluntary groups • C. Medical institutions • D. Pharmaceutical companies • E. Government agencies • F. CAB • G. All of the above Understanding the Clinical Research Process and Principles of Clinical Research

  13. What Do You Know? • A. There are various routes of transmission • Why is HIV/AIDS a difficult disease to research? • B. There are known cures but people do not have access to them • C. Different treatment options lead to different outcomes • D. A and B only • E. A and C only • F. All of the above Understanding the Clinical Research Process and Principles of Clinical Research

  14. What Do You Know? • A. A job for scientists to identify the causes for disease • What is research? • B. Work in a laboratory to treat disease • C. A systematic investigation to establish fact • D. A study paid for by the United Nations Understanding the Clinical Research Process and Principles of Clinical Research

  15. What Do You Know? • A. Inclusion • Before someone can participate in a clinical trial, they need to meet which type of criteria? • B. Exclusion • C. Both A and B • C. Bot A and B Understanding the Clinical Research Process and Principles of Clinical Research

  16. What Do You Know? • A. How treatments are administered to study participants • What is included in a research protocol? • B. Important facts potential participants should know about the clinical trial before deciding to participate • C. Instructions for assigning participants to study arms • D. Both A and B Understanding the Clinical Research Process and Principles of Clinical Research

  17. What Do You Know? • A. The conduct of research • Ethical principles guide clinical research activities, including (select all that apply): • B. The analysis of research data • C. The building of new research facilities • D. The design of research studies • E. The formation of research questions Understanding the Clinical Research Process and Principles of Clinical Research

  18. What Do You Know? • A. Social stigma for participating in a trial about a sexually transmitted disease • Which of the following are risks of participating in an HIV/AIDS Phase I clinical trial? • B. The severity of the side effects that might occur • C. The potential for a participant to become HIV-positive during the trial • D. All of the above Understanding the Clinical Research Process and Principles of Clinical Research

  19. The Role of a CAB • In this section, we will describe and discuss the role of a CAB in the research process, including: Understanding the Clinical Research Process and Principles of Clinical Research

  20. What Is the Role of a CAB in the Research Process? • National Community • Larger Community • Participant’s Family and Close Friends • Global Community • Surrounding Community Understanding the Clinical Research Process and Principles of Clinical Research

  21. What Is a Community? • A community shares common: • Geography • Racial or ethnic makeup • Values, culture, beliefs and interests People can belong to many communities at the same time. Communities and the demographics of a target population are always changing. Understanding the Clinical Research Process and Principles of Clinical Research

  22. Group Brainstorm and Discussion • Who is in YOUR community? • Why is it important to have different kinds of people in a community? Understanding the Clinical Research Process and Principles of Clinical Research

  23. Purpose of CABs Understanding the Clinical Research Process and Principles of Clinical Research

  24. What Is the History of CABs? • AIDS activists in the U.S. and Europe: Demanded that researchers and regulatory authorities move more quickly to find medications to fight HIV Looked for opportunities to review trial proposals Protested by letter-writing, and lobbying the U.S. Government they succeeded Understanding the Clinical Research Process and Principles of Clinical Research

  25. What Is the History of CABs?(cont’d) This process resulted in the creation of CABs made up of non-scientists. These non-scientistsreview protocols, monitor trials, and help educate and inform the rest of the community. Understanding the Clinical Research Process and Principles of Clinical Research

  26. Who Participates on a CAB? Volunteers with a broad range of backgrounds • Religious groups • Schools or universities • Media • Non-governmental organizations / community-based organizations Understanding the Clinical Research Process and Principles of Clinical Research

  27. Who Participates on a CAB? (cont’d) Members often have an interest in HIV prevention and treatment Ideally 50% of the CAB’s members are from the target population of a site’s trials Some CAB members are paid, but usually they are not Over time, members can better understand the discussions and contribute to the conversations about the clinical trial Understanding the Clinical Research Process and Principles of Clinical Research

  28. Does this individual exhibit the characteristics of a CAB member? What Do You Know? A 24-year-old female teacher at a community school A. YES B. NO Understanding the Clinical Research Process and Principles of Clinical Research

  29. Does this individual exhibit the characteristics of a CAB member? What Do You Know? A 30-year-old female who is known to be disruptive and disrespectful of others’ opinions A. YES B. NO Understanding the Clinical Research Process and Principles of Clinical Research

  30. How Are CABs Involved in the Community? CAB • Community • ResearchTeam Understanding the Clinical Research Process and Principles of Clinical Research

  31. How Do Researchers and CABs Interact? • Researchers • Protocol development • Protocol implementation • Site preparedness • Community preparedness • Trial operations • Site monitoring/data analysis • Human subject safety/liability • CAB • Participatory communications • Community education • Advice on recruitment and retention • Representative voice for participants Ethical Research Information During Trial Issues Management Understanding the Clinical Research Process and Principles of Clinical Research

  32. Group Brainstorm and Discussion How do you think a person’s community affects his/her health options and accessibility to research opportunities? Discuss issues of confidentiality. In what ways will community and CAB support help Sarah be more likely to successfully complete the research she is part of? Understanding the Clinical Research Process and Principles of Clinical Research

  33. In this section we will describe and discuss: KeyPartnerships The Clinical Trials Network The Community Partners Organization Understanding the Clinical Research Process and Principles of Clinical Research

  34. The Clinical Trials Networks The HIV Vaccine Trials Network (HVTN) The AIDS Clinical Trials Group (ACTG) The HIV Prevention Trials Network (HPTN) International Material PediatricAdolescent AIDS Clinical Trials (IMPAACT) The Microbicide Trials Network (MTN) International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) Understanding the Clinical Research Process and Principles of Clinical Research

  35. IMPAACT HVTN INSIGHT HPTN MTN ACTG What Are Community Partners? Community Partners organized through the HIV/AIDS NetworkCoordination Office Community Partners organized through the HIV/AIDS NetworkCoordination Office Understanding the Clinical Research Process and Principles of Clinical Research

  36. What are Cross-Network Activities? Community Input Data Management Evaluation Measures Training Development of Staff Scientific Leadership and Collaboration Laboratory Processing Site Management Understanding the Clinical Research Process and Principles of Clinical Research

  37. Who Supports and Partners withClinical Trial Networks Organizations that provide support include: Division of AIDS (DAIDS) HIV/AIDS Network Coordination (HANC) Statistical and operation centers Central laboratories Contract Research Organization (CRO) • Partners within the NIH include: • Nation Institute of Child Health and Human Development • National Institute of Mental Health • National Cancer Institute • National Institute on Drug Abuse • National Institute of Dental and Craniofacial Research • Office of AIDS Research Understanding the Clinical Research Process and Principles of Clinical Research

  38. Who are Other Partners? Understanding the Clinical Research Process and Principles of Clinical Research

  39. The Importance of Worldwide AIDS Research A person who is infected with HIV develops antibodies to fight the infection. Someone with the antibodies in their blood is “HIV-positive.” HIV disease becomes AIDS when a person’s immune system is highly compromised by the effects of the virus. Understanding the Clinical Research Process and Principles of Clinical Research

  40. What Is the History of AIDS? There were cases of AIDS in the 1950s. AIDS cases grew during the late 1970s and 1980s AIDS is now a global epidemic. AIDS has become one of the greatest threats to human health and development. Understanding the Clinical Research Process and Principles of Clinical Research

  41. What Are the DAIDS’ Top Scientific Priorities for HIV/AIDS Research Worldwide? • Unravel the fundamental processes governing host/virus interactions DAIDS (Division of AIDS) has identified six important areas of research to: Understanding the Clinical Research Process and Principles of Clinical Research

  42. How Serious is AIDS? Understanding the Clinical Research Process and Principles of Clinical Research

  43. Why Is Worldwide HIV Research Important? HIV is transmitted by different routes, in different people, at different intervals, with different treatment options that lead to different outcomes No single organization has the resources to complete the needed HIV/AIDS research Understanding the Clinical Research Process and Principles of Clinical Research

  44. What Are theMillennium Development Goals (MDGs)? • The United Nations identified an action agenda for this millennium — eight millennium development goals. One of the MDGs focuses on HIV/AIDS. • It calls on the world community to halt and begin to reverse the spread of HIV by 2015. Understanding the Clinical Research Process and Principles of Clinical Research

  45. Clinical Research August 2012 This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272201200009C, entitled NIAID HIV and Other Infectious Diseases Clinical Research Support Services (CRSS).

  46. Clinical Research Understanding the Clinical Research Process and Principles of Clinical Research

  47. What Is Clinical Research? Understanding the Clinical Research Process and Principles of Clinical Research

  48. What Is a Clinical Trial? Understanding the Clinical Research Process and Principles of Clinical Research

  49. What Is a Clinical Trial? (cont’d) • Trials cannot be conducted if the outcome is already known from a previous study. Trials can only be conducted if there is an uncertainty about the outcome. Understanding the Clinical Research Process and Principles of Clinical Research

  50. Why Is Research Important? Understanding the Clinical Research Process and Principles of Clinical Research

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