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Clinical Trials and Research

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Clinical Trials and Research A Guide for Community Advisory Board Members Trainer Manual * Researchers assign participants to a medicine group at random. – PowerPoint PPT presentation

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Title: Clinical Trials and Research


1
Clinical Trials and Research
  • A Guide for Community Advisory Board Members
  • Trainer Manual

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.

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

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

6
Phases of Clinical Trials
7
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
8
Randomisation
Control Group
Investigational Group
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.

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

11
Informed Consent
  • Purpose
  • Medicine to be studied
  • Procedures and schedule
  • Risks
  • Potential benefits
  • Alternatives to participation
  • Confidentiality

12
Informed Consent
  • Participation in clinical trials is always
    voluntary.

Yes, I would like to participate.
No, thank you, Id rather not participate.
13
Research Protocol
14
Objectives Clear and Specific Statements
  • Which medicine is more effective in reducing
    mother-to-child transmission of HIVMedicine A
    or Medicine B?

15
Eligibility
  • Who may participate in this study
  • Who may not (X) participate in this study

X
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.

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

18
Schedule of Events
Mon Tue Wed Thurs Fri Sat Sun
1 2 3 4 5 6 7
8 9 10 11 12 13 14
15 16 17 18 19 20 21
22 23 24 25 26 27 28
29 30
  • To evaluate the effect of the medicine on their
    health, all patients in a trial have certain
    tests or procedures at regularly scheduled
    intervals.

19
Endpoints
  • An endpoint is what researchers will measure to
    evaluate the results of a new medicine.


20
CAB Part of the Research Team
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.

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.

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.

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