clinical trials and research a guide for community advisory board members participant manual
TRANSCRIPT
Clinical Trials and Research
A Guide for Community Advisory Board Members
Participant Manual
Clinical Trials & Research 2
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
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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?
Medicine “B”
Medicine “A”
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Phase I:Safety
(15–30 people)
Phase II: Safety and Effectiveness(Fewer than 100 people)
Phase III: Effectiveness compared to standard of care; Safety
(More than 100 to a few thousand)
A A A
A
A A A
A
A A A
A
A A A
A
A A A
A
A A A
A
A A A
A
A A A
A
Phases of Clinical Trials
A A A
A
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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”
A A A
A
B
B
B B
B
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RandomisationA A
A A
B
B
B B
B
Investigational Group
Control 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.
No, thank you, I’d rather not participate.
Yes, I would like to
participate.
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Research Protocol
How
Why
Where
When
What
Who
Protocol
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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”
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Eligibility Who may participate in this study Who may not (X) participate in this
study
X X
X
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
To evaluate the effect of the medicine on their health, all patients in a trial have certain tests or procedures at regularly scheduled intervals.
Mon Tue Wed Thurs Fri Sat Sun
1 2 3 4 5 6 7
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15 16 17 18 19 20 21
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29 30
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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.