Transcript Physician Contracting - University of Tennessee Health

How to Find and Access
Clinical Trials
New Treatments, No Tricks
A Seminar on Minority Participation in Clinical Trials
June 15, 2010
Before You Start:
Understanding Clinical Trials
(What they are, Why they are important, The risks
and benefits to participating)
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What Is a Clinical Trial?
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Clinical trials are an important part of the
research process.
A clinical trial is a research study
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Conducted with people
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To answer specific health or health-related questions
That follows a study plan called a Protocol
The majority of clinical trials conducted in the
U.S. test new drugs.
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As compared to laboratory research or animal studies (preclinical)
Source: National Medical Association
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Stages in the Development of Drugs
Laboratory Research
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Animal Studies
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Clinical Trials
Source: National Medical Association
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What is a Protocol?
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Clinical trials are conducted according to a
plan called a Protocol.
A Protocol is a study plan that describes,
among other things:
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The types of individuals that may or may not enter the study
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Age, gender, the type and stage of a disease, previous
treatment history, and other medical conditions
The schedule of services and procedures, drugs, dosages,
and length of the study
How the outcomes of the study will be measured
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Why Are Clinical Trials Important?
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Clinical trials are an important step in
discovering new treatments for conditions and
diseases
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As well as new ways to detect, diagnose, and reduce the risk
of disease.
Clinical trials help determine what does and
does not work in people.
Many people have been helped and are alive
because other people (you!) chose to
participate in a trial that resulted in a new,
more effective treatment.
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Do Many People Take Part in Clinical
Trials?
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Few people participate.
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One 2008 study showed that less than 1% of the American
population participate in clinical trials.
In addition, women, older people, minorities,
disabled individuals, and rural populations
have been underrepresented in clinical trials
for decades.
Why?
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Who Sponsors Clinical Trials?
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Clinical trials are sponsored or funded by a
variety of organizations:
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Federal agencies
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Pharmaceutical companies
Device companies
Foundations
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National Institutes of Health (NIH)
Department of Defense (DoD)
Department of Veteran’s Affairs (VA)
A type of nonprofit corporation that may either donate funds
and/or provide support to other organizations for charitable
activities.
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What Types of Clinical Trials are There?
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The NIH organizes trials into five (5) types:
1.
Prevention
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2.
Screening
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3.
Tests the best ways to detect certain diseases or health
conditions
Diagnostic
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Looks for better ways to prevent disease in people who have
never had the disease or prevent the disease from returning
Tests the best ways to detect certain diseases or health
conditions
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What Types of Clinical Trials are There?
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The NIH five (5) types continued:
4.
Treatment
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5.
Quality of Life
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Tries to find better tests and procedures for diagnosing a
particular disease or condition
Studies options for improving the quality of life for people
who have certain medical conditions
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What are the Phases of Clinical Trials of
New Drugs?
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Phase I
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Researchers test an experimental drug or treatment in a
small group of people (20-80) for the first time to evaluate
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Phase II
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The experimental study drug or treatment is given to a
larger group of people (100-300) to see if it is
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safety,
determine safe dose range, and
identify side effects.
effective and to
further evaluate its safety.
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What are the Phases of Clinical Trials of
New Drugs?
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Phase III
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The experimental drug or treatment is given to a large
group of people (1,000-3,000) to confirm
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effectiveness,
monitor side effects,
compare it to commonly used treatments, and
collect information that will allow the experimental drug or
treatment to be used safely.
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What are the Phases of Clinical Trials of
New Drugs?
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Phase IV
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Post marketing studies (drug has been approved by the
Food and Drug Administration) that
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gather additional information, including the drug’s risks,
benefits, and optimal use.
Source: ClinicalTrials.gov
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Potential Benefits of Taking Part
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Opportunity to get actively involved in your
health care
Potentially receive free health screenings and
exams
Gain access to potentially new research
treatments
Access to expert medical care for the condition
being studied and close monitoring
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Since investigators are often specialists in study area
Have the chance to help others and improve
medical care
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Potential Risks of Taking Part
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Unpleasant and serious side effects
Treatment may not be effective for all study
subjects
Protocol may require more time and attention
than standard treatment
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For some trials, there may be expenses not
covered by the sponsor of the trial.
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May need to visit the study site on a regular basis
More treatments than normal
Possible costs are discussed during the informed consent
process and documented in the informed consent form.
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Finding a Clinical Trial:
The Next Steps
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Finding Clinical Trials
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Your healthcare provider
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Remember – your best starting point is your doctor and
other members of your healthcare team
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The newspaper, radio, television
Local universities, health providers, and
hospitals
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They can help you determine whether a clinical trial is a good
option.
Examples - The University of Tennessee Health Science
Center, Methodist Foundation, The Regional Medical Center
at Memphis, UT Medical Group, Inc.
The Internet
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Using the Internet to Find A Clinical Trial
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ClinicalTrials.gov
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ClinicalTrials.gov is maintained by the National Library of
Medicine and is a service of the National Institutes of Health.
It is a registry of federally and privately supported clinical
trials conducted in the United States and around the world.
Internet address: http://clinicaltrials.gov
Will provide you with information on a trial such as:
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The trial’s purpose
Who may participate
Locations
Phone numbers for more details
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Fill in as
much or as
little as
you wish!
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Using the Internet to Find a Clinical Trial
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CenterWatch
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CenterWatch is a third-party clinical trial website that is not
operated by funders, sponsors, or organizations carrying out
clinical trials.
It offers information on clinical trials, news and analysis,
study grants, and trial listings to professions and patients.
Internet address: http://www.centerwatch.com/
Can search clinical trials by:
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Medical condition
Therapeutic area
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Note the
different
pages listed
by letters of
the alphabet!
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Using the Internet to Find a Clinical Trial
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Industry-Sponsored Sites
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If you are aware of a treatment and know the company that
manufactures it, locate the Website of the company.
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Try a search engine like Google
Some of largest pharmaceutical companies:
 Johnson & Johnson - http://www.jnj.com/
 Pfizer - http://www.pfizer.com/
 Roche – http://www.roche.com/
 GlaxoSmithKline - http://www.gsk.com/
Find company’s customer service telephone number
When you call, ask to speak to the company’s clinical trial
department
Tell them that you are looking for a trial that you might be
eligible to join
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After Finding a Clinical Trial:
Whether or Not to Participate
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Make a List of Potential Trials
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Trial objective
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Eligibility criteria
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Does your diagnosis and current overall state of health
match the eligibility criteria? This may tell you whether you
qualify for the trial.
Trial location
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Make sure the trial’s main objective matches your goals
Is the location of the trial manageable for you? Is parking
available? Look carefully at how often you will be required
to go to the trial site and decide how far and often you are
willing to travel.
Study duration
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Will the time commitment work for you and your family?
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Contact the Clinical Trial Team
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Contact the team directly
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Through your research, you should have the name and
telephone number of someone you can contact for more
information.
Ask to speak with the study coordinator
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A study coordinator works under the direction of the principal
investigator and is responsible for the organization and
coordination of a research project.
 For example - Screening, recruiting, and enrolling
participants, consenting, collecting data, and scheduling
The study coordinator can answer questions about a trial.
The trial coordinator may also be responsible for determining
whether you are likely eligible to join the trial.
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Questions To Ask
1.
2.
3.
4.
5.
6.
Is the trial still open?
What is the purpose of the trial?
Am I eligible for the trial?
Who is sponsoring the trial?
How long will the trial last?
What kind of tests, procedures, or
treatments will be performed?
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How many?
How often?
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Questions to Ask
9. What costs will I be responsible for?
•
Service and/or procedures
10.Will I be paid for childcare, travel, and other
expenses?
11.What are the risks and benefits?
•
How do the risks and benefits compare to my current
treatment?
12.Can I leave the trial at anytime?
13.How will participating in the trial affect my
everyday life?
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After Finding a Clinical Trial:
Final Steps
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Discuss and Review Options
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It is helpful to talk with your doctor, family
members, and/or friends before joining a trial.
Be sure to know all the various treatment
options and understand possible risks and
benefits
You may decide that joining a trial is your best
option or you may decide not to join.
It is your choice
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Schedule an Appointment
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If you decide that the clinical trial is the best
option for you, schedule an appointment with
the study coordinator.
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Learn as Much as You Can about the
Clinical Trial Before Deciding to
Participate
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For More Information
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National Institutes of Health
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http://www.nih.gov/
ClinicalTrials.gov can be accessed through the National
Institutes of Health website
Food and Drug Administration
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An agency of the Department of Health and Human Services
and is the primary Federal agency for conducting and
supporting medical research.
An agency of the Department of Health and Human Services
responsible for protecting and promoting public health
through the regulation and supervision of many areas,
including pharmaceutical drugs and medical devices.
http://www.fda.gov/
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How to Find and Access
Clinical Trials
Alisa M. Firehock, MHA, FACHE
Executive Director
Tennessee Clinical Trials Network
[email protected]
901-448-6977 office
901-448-1512 fax
Please visit the Tennessee Clinical Trials website at:
http://www.tctn.org