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How to Find and Access Clinical Trials
New Treatments, No TricksA 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?
Clinical trials are an important part of the research process.
A clinical trial is a research study Conducted with people
As compared to laboratory research or animal studies (pre-clinical)
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.
Source: National Medical Association
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Stages in the Development of Drugs
Laboratory Research
Animal Studies
Clinical Trials
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Source: National Medical Association
What is a Protocol?
Clinical trials are conducted according to a plan called a Protocol.
A Protocol is a study plan that describes, among other things:
The types of individuals that may or may not enter the study
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?
Clinical trials are an important step in discovering new treatments for conditions and diseases
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?
Few people participate. 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.
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Why?
Who Sponsors Clinical Trials?
Clinical trials are sponsored or funded by a variety of organizations:
Federal agencies National Institutes of Health (NIH) Department of Defense (DoD) Department of Veteran’s Affairs (VA)
Pharmaceutical companies Device companies Foundations
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?
The NIH organizes trials into five (5) types: 1. Prevention
• Looks for better ways to prevent disease in people who have never had the disease or prevent the disease from returning
2. Screening• Tests the best ways to detect certain diseases or
health conditions
3. Diagnostic• Tests the best ways to detect certain diseases or
health conditions
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What Types of Clinical Trials are There?
The NIH five (5) types continued: 4. Treatment
• Tries to find better tests and procedures for diagnosing a particular disease or condition
5. Quality of Life• 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?
Phase I Researchers test an experimental drug or treatment
in a small group of people (20-80) for the first time to evaluate
safety, determine safe dose range, and identify side effects.
Phase II The experimental study drug or treatment is given to
a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
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What are the Phases of Clinical Trials of New Drugs?
Phase III The experimental drug or treatment is given to a
large group of people (1,000-3,000) to confirm 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?
Phase IV Post marketing studies (drug has been approved by
the Food and Drug Administration) that gather additional information, including the drug’s
risks, benefits, and optimal use.
Source: ClinicalTrials.gov
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Potential Benefits of Taking Part
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
Since investigators are often specialists in study area Have the chance to help others and
improve medical careJuly 15, 2010 14
Potential Risks of Taking Part
Unpleasant and serious side effects Treatment may not be effective for all
study subjects Protocol may require more time and
attention than standard treatment May need to visit the study site on a regular basis More treatments than normal
For some trials, there may be expenses not covered by the sponsor of the trial.
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
Your healthcare provider Remember – your best starting point is your doctor
and other members of your healthcare team They can help you determine whether a clinical trial is a
good option.
The newspaper, radio, television Local universities, health providers, and
hospitals Examples - The University of Tennessee Health
Science Center, Methodist Foundation, The Regional Medical Center at Memphis, UT Medical Group, Inc.
The InternetJuly 15, 2010 17
Using the Internet to Find A Clinical Trial
ClinicalTrials.gov 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:
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
CenterWatch 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:
Medical condition Therapeutic area
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Note the different
pages listed by letters of
the alphabet!
Using the Internet to Find a Clinical Trial
Industry-Sponsored Sites If you are aware of a treatment and know the company
that manufactures it, locate the Website of the company.
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 joinJuly 15, 2010 29
After Finding a Clinical Trial:Whether or Not to
Participate
July 15, 2010 30
Make a List of Potential Trials
Trial objective Make sure the trial’s main objective matches your
goals Eligibility criteria
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 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 Will the time commitment work for you and your
family?July 15, 2010 31
Contact the Clinical Trial Team
Contact the team directly 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 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. Is the trial still open?2. What is the purpose of the trial?3. Am I eligible for the trial?4. Who is sponsoring the trial?5. How long will the trial last?6. What kind of tests, procedures, or
treatments will be performed? 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
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
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
National Institutes of Health An agency of the Department of Health and Human
Services and is the primary Federal agency for conducting and supporting medical research.
http://www.nih.gov/ ClinicalTrials.gov can be accessed through the National
Institutes of Health website Food and Drug Administration
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, FACHEExecutive Director
Tennessee Clinical Trials Network
[email protected] office901-448-1512 fax
Please visit the Tennessee Clinical Trials website at: http://www.tctn.org
