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

Clinical Trials & Research2 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. PACTG Global Training Initiative

Clinical Trials & Research3 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 & Research4 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 & Research5 Example of a Research Question  Is Medicine A more effective for preventing mother-to- child transmission than Medicine B? Medicine “B” Medicine “A”

Clinical Trials & Research6 Phases of Clinical Trials

Clinical Trials & Research7 Structure of a Simple Trial Comparing Two Treatments Study Sample R= Random assignment of patients to a treatment arm R Medicine “A” Medicine “B” Result “A” Result “B”

Clinical Trials & Research8 Randomisation Investigational Group Control Group

Clinical Trials & Research9 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 & Research10 Informed Consent  To make informed decisions, patients need to hear and understand specific information about the research.

Clinical Trials & Research11 Informed Consent  Purpose  Medicine to be studied  Procedures and schedule  Risks  Potential benefits  Alternatives to participation  Confidentiality

Clinical Trials & Research12 Informed Consent  Participation in clinical trials is always voluntary. No, thank you, I’d rather not participate. Yes, I would like to participate.

Clinical Trials & Research13 Research Protocol Protocol WhoWhatWhenWhereWhyHow

Clinical Trials & Research14 Objectives: Clear and Specific Statements  Which medicine is more effective in reducing mother-to-child transmission of HIV—Medicine “A” or Medicine “B”? Medicine “B” Medicine “A”

Clinical Trials & Research15 Eligibility  Who may participate in this study  Who may not (X) participate in this study X X X X

Clinical Trials & Research16 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 & Research17 Safety  A protocol must describe known risks or side effects and exactly what will be done to protect and monitor patients.

Clinical Trials & Research18 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. MonTueWedThursFriSatSun

Clinical Trials & Research19 Endpoints  An endpoint is what researchers will measure to evaluate the results of a new medicine

Clinical Trials & Research20 CAB: Part of the Research Team

Clinical Trials & Research21 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 & Research22 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 & Research23 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 & Research24 How Have Clinical Trials Helped People with HIV?  They have greatly decreased sickness and death among patients who receive antiretroviral medicine.