Download Phases of Clinical Trials - AIDS Clinical Trials Group

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Why Clinical Research is
Important to Persons with
HIV/AIDS
Developed for the
AIDS Clinical Trials Group
by the
Recruitment and Retention Subcommittee
of the Patient Care Committee
We will cover…….
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What Does Research Do
Why Participate?
Lessons From the Past
Protections for Study
Volunteers
• How Trials Work
• Involving the
Community in the
Research Effort
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
Why HIV Clinical Trials?
• Is the investigational treatment safe?
• Do treatments work the same in
women? In men? In children?
• What about side effects?
I Found the Cure!
If it sounds
too good to be true . . .
IT PROBABLY IS!
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
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
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
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
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.
Possible Concerns of
Participation
• Time and commitment
• Discomfort from medical procedures
• Side effects
• Reminder of HIV-positive status
Possible Concerns of
Participation (cont’d)
• Feeling of being a guinea pig
• Lack of treatment flexibility
• May limit future treatment options
• Privacy
Lessons Learned From the Past
Tuskegee Experiment
Thalidomide
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.
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.
Questions & Concerns
Question:
Could these kinds of
things happen again?
Answer
There are now several safety nets in place
to protect volunteers.
• Data Safety and Monitoring Board
• Institutional Review Board
Institutional Review Board
(IRB)
• Is locally based
• Includes community representatives
• Ensures:
– A proper consent process
– Benefit potential outweighs risk
– Research is ethical
Protecting the Rights
of Volunteers
Question:
How can the rights of
volunteers be protected?
Protecting the Rights
of 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
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.
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
Clinical Trial Phases
PHASE I
Question
Risk
Length
Number of
participants
Is the treatment safe?
PHASE II
Does the treatment
work?
PHASE III
What are the longterm results in lots of
people?
Riskiest-First trials in Moderate risk –
Lowest risk – More
humans. Performed in Some safety
information about
HIV+ and HIV –
information about the safety and
volunteers. Used to
drug is known.
effectiveness is
determine doses.
known.
Shortest – A few
Medium Length –
Longest – May last
weeks to a few
Usually about a year. for two to three years.
months.
Few participants
About one hundred
At least several
participants
hundred participants.
Adapted from “Clinical Trials Explained - Community Initiative on AIDS (CRIA)
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
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
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
Placebo-Controlled Trials
• 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.
Randomization
Assigned by chance, as if by a toss
of the coin, to one or more “arms”
(groups) of the study.
Access to Clinical Trials
All HIV-positive individuals are welcome to be
screened at the local Clinical Research Site
clinic for possible participation.
Eligibility Criteria
Every study has its own set of
eligibility criteria
Inclusion Criteria
- What it takes to get in
Exclusion Criteria
- What may keep a person out
Who Can Participate?
Participation of Special
Populations
• Pregnant Women
• Children
• Prisoners
• Other
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
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
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
Clinical Trials Information
Contact for clinical trials:
1-800-TRIALS-A
(1-800-874-2572)
www.actis.org
Local Clinical Research Site
Contact Information
• (Add site-specific info here
– Address and phone numbers)
• Name of Nurse Coordinator
• Name of Principal Investigator
• Others
Summary
• What Does Research • How Trials Work
Do
• Involving the
• Why Participate
Community in the
Research Effort
• Lessons From the
Past
• Protections for Study
Volunteers
The Importance Of
Scientific Research
A life is not important except in the impact
it has on other lives…
Jackie Robinson