presenter instructions this slide presentation is designed to assist you with your education efforts...
TRANSCRIPT
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Presenter Instructions
• This slide presentation is designed to assist you with your education efforts about clinical trials. Each slide includes a note section to help guide the presenter.
• To print slides with notes: – File, print, at the “print what box” select
handouts, check pure black and white, OK (40 pages)
• Please complete the Evaluation Form
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Why Clinical Research is Important to Persons with
HIV/AIDSDeveloped for the
AIDS Clinical Trials Group
by the
Recruitment and Retention Subcommittee
of the Patient Care Committee
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We will cover…….
• What Does Research Do
• Why Participate?
• Lessons From the Past
• Protections for Study Volunteers
• How Trials Work
• Involving the Community in the Research Effort
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What Does Research do?
• Finds answers to difficult scientific or health questions
• Finds out whether and how procedures, tests, or investigational medicines work
• Determines how gender, age and race affect the effectiveness of investigational treatments
• Uses nonexperimental observation – watching and measuring but not involving drug or procedure
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Why HIV Clinical Trials?
• Is the investigational treatment safe?
• Do treatments work the same in women? In men? In children?
• What about side effects?
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I Found the Cure!
If it sounds
too good to be true . . .
IT PROBABLY IS!
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False cures
“Compound Q”A Chinese herb which was believed to have “anti-HIV” properties and
was used by underground buyers in the late 1980’s and early 1990’s
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The Pressure Is On• Because HIV is life threatening and the
epidemic continues to grow, there is great pressure to complete studies quickly and efficiently
• Carefully designed, scientific studies set the
standards for patient care
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Advantages of Participation
HEALTH
• Frequent monitoring of health status and early detection of complications
• Help with taking medicines correctly
• Early access to investigational medicines and tests
• Some studies show that people who participate in clinical trials do better than those who do not
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Advantages of Participation
OTHER
• A chance to be part of the solution
• Free lab work and some trial medicines
• Personalized, friendly, confidential care
• Partnership with primary care provider
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Relationship With Primary Care Provider
• Every volunteer must have a primary care
provider.
• The primary care provider will be kept
informed of the status of the study and
receive laboratory results with the
volunteer’s consent.
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Possible Concerns of Participation
• Time and commitment
• Discomfort from medical procedures
• Side effects
• Reminder of HIV-positive status
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Possible Concerns of Participation (cont’d)
• Feeling of being a guinea pig
• Lack of treatment flexibility
• May limit future treatment options
• Privacy
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Lessons Learned From the Past
Tuskegee Experiment
Thalidomide
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The Tuskegee Experiment
A 40 year government study of the effects of untreated syphilis in Black men in Tuskegee, Alabama, in which participants were offered free treatment and follow-up for “Bad Blood.” In fact, they were not treated, even when a cure became available in the 1940’s.
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The Thalidomide Disaster
A drug already approved for use in Europe and Canada (1957-1962) was later found to cause severe birth defects in the children of women who took it during pregnancy. Some of these birth defects included the absence of arms and legs in the babies born to these women.
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Questions & Concerns
Question:
Could these kinds of
things happen again?
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Answer
There are now several safety nets in place to protect volunteers.
• Data Safety and Monitoring Board
• Institutional Review Board
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Institutional Review Board (IRB)
• Is locally based• Includes community representatives• Ensures:
– A proper consent process– Benefit potential outweighs risk– Research is ethical
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Protecting the Rightsof Volunteers
Question:
How can the rights of
volunteers be protected?
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Protecting the Rightsof Volunteers
Answer:
•Carefully Read the informed consent document•Ask questions•Ask to speak with a study volunteer•Join the Community Advisory Board•The choice is the volunteer’s participation is always voluntary
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What Is a Clinical Trial?
A clinical trial is a planned experiment that
involves volunteers and is designed to
determine the most appropriate treatment for
future patients with a given medical
condition.
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Phases of Clinical Trials
•An investigational medication must go
through different phases of clinical trials
before Food and Drug Administration
approval.
•Laboratory studies first, then animal studies, then human studies
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Clinical Trial Phases PHASE I
PHASE II PHASE III
Question Is the treatment safe? Does the treatment work?
What are the long-term results in lots of people?
Risk Riskiest-First trials in humans. Performed in HIV+ and HIV – volunteers. Used to determine doses.
Moderate risk – Some safety information about the drug is known.
Lowest risk – More information about safety and effectiveness is known.
Length Shortest – A few weeks to a few months.
Medium Length – Usually about a year.
Longest – May last for two to three years.
Number of participants
Few participants About one hundred participants
At least several hundred participants.
Adapted from “Clinical Trials Explained - Community Initiative on AIDS (CRIA)
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Phase I Clinical Trials
• Look at drug safety and toxicity
• Measure how the drug is absorbed and
how much is found in the blood
• Require small numbers of volunteers
• Are a short duration
• Close monitoring of volunteers
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Phase II Clinical Trials
• Continue to evaluate drug safety
• Determine the dose that works the best with the least side effects
• Involve a larger number of volunteers
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Phase III Clinical Trials
• Continue to evaluate drug safety
• Compare investigational drug with current standard treatment
• Monitor long-term effectiveness
• Involve larger numbers of volunteers
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• Studies where a new drug is compared to a pill that has no harmful, nor helpful effects.
• The pill will look, feel, taste and smell like an actual medication
• Double-blinded: Neither the medical provider nor the study volunteer knows who is taking a placebo or not. In ACTG studies only the site pharmacist knows.
Placebo-Controlled Trials
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Randomization
Assigned by chance, as if by a toss of the coin, to one or more “arms” (groups) of the study.
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Access to Clinical Trials
All HIV-positive individuals are welcome to be screened at the local Clinical Research Site
clinic for possible participation.
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Eligibility CriteriaEvery study has its own set of
eligibility criteria
Inclusion Criteria
- What it takes to get in
Exclusion Criteria
- What may keep a person out
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Who Can Participate?
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Participation of Special Populations
• Pregnant Women
• Children
• Prisoners
• Other
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Community Advisory Boards (CAB)
Every Clinical Research Site should have an established CAB whose members reflect:
Demographics of the HIV epidemic:
– Age, gender
– Racial and ethnic populations
– Multiple educational/literacy/language levels
The various routes of HIV transmission:
– Sexual transmission (Gay/Bi/Straight)
– Injection drug users and their partners
– Mom to child; exposure to blood products
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Role of the Community Advisory Board (CAB)
• Members of the CAB assist the local Clinical Research Site in selection and implementation of trials
• CABs are the liaison to the community
• CABs help people with HIV better understand clinical trials
• CABs improve access to trials so that everyone may benefit from the trial findings
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JOIN!Community Advisory Board• (Place the Date, Time, and Location of meetings
here)
• Learn from researchers about investigational studies and the latest results in HIV treatment
• Serve as a liaison between (name of Center) and HIV-positive communities
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Clinical Trials Information
Contact for clinical trials:
1-800-TRIALS-A
(1-800-874-2572)
www.actis.org
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Local Clinical Research Site Contact Information
• (Add site-specific info here– Address and phone numbers)
• Name of Nurse Coordinator
• Name of Principal Investigator
• Others
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Summary
• What Does Research Do
• Why Participate
• Lessons From the Past
• Protections for Study Volunteers
• How Trials Work
• Involving the Community in the Research Effort
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The Importance Of Scientific Research
A life is not important except in the impact it has on other lives…
Jackie Robinson