Clinical Trials and Research

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Clinical Trials and Research

• A Guide for Community Advisory Board Members
• Trainer Manual

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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.

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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

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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.
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Example of a Research Question

• Is Medicine A more effective for preventing
  mother-to-child transmission thanMedicine B?

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Phases of Clinical Trials
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Structure of a Simple Trial Comparing Two
Treatments
Medicine A
Result A
Study Sample
R
Result B
Medicine B
R Random assignment of patients to a treatment
arm
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Randomisation
Control Group
Investigational Group
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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.

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Informed Consent

• To make informed decisions, patients need to hear
  and understand specific information about the
  research.

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Informed Consent

• Purpose
• Medicine to be studied
• Procedures and schedule

• Risks
• Potential benefits
• Alternatives to participation
• Confidentiality

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Informed Consent

• Participation in clinical trials is always
  voluntary.

Yes, I would like to participate.
No, thank you, Id rather not participate.
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Research Protocol
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Objectives Clear and Specific Statements

• Which medicine is more effective in reducing
  mother-to-child transmission of HIVMedicine A
  or Medicine B?

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Eligibility

• Who may participate in this study
• Who may not (X) participate in this study

X
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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.

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Safety

• A protocol must describe known risks or side
  effects and exactly what will be done to protect
  and monitor patients.

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Schedule of Events
Mon Tue Wed Thurs Fri Sat Sun
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• To evaluate the effect of the medicine on their
  health, all patients in a trial have certain
  tests or procedures at regularly scheduled
  intervals.

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Endpoints

• An endpoint is what researchers will measure to
  evaluate the results of a new medicine.

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CAB Part of the Research Team
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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.

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How Have Clinical Trials Helped People with HIV?

• Clinical trials are critical in the effort to
  find better ways to treat HIV and AIDS.

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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.

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How Have Clinical Trials Helped People with HIV?

• They have greatly decreased sickness and death
  among patients who receive antiretroviral
  medicine.