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Raising Awareness. Funding Research.
Supporting Patients. Achieving the DREAM!
www.DebbiesDream.org
New York Stomach Cancer Education Symposium
Clinical Trials
Lecturer – Lakshmi Rajdev, MD, MS
Albert Einstein Cancer Center
Bronx, NY
Debbie’s Dream Foundation Medical Advisory Board Member
Bridging the Gap Between
Laboratory Science and
Human Health
What Is a Clinical Trial?
o Clinical trials are research studies that involve people.
o Through clinical trials, doctors find new ways to improve
treatments and the quality of life for people with disease.
Clinical Trials
Researchers design cancer clinical trials to test new ways
to:
o Find and diagnose cancer
o Treat cancer
o Prevent cancer
o Manage symptoms of cancer and side effects from its
treatment
Clinical Trials
These studies are designed to answer questions about
new treatments or ways of using existing treatments better.
These trials test many types of treatments such as new:
o Drugs or vaccines
o Ways to do surgery or give radiation therapy
o Combinations of treatments
Many treatments used today are the results of
past clinical trials!!
Clinical Trials Advancing
Cancer Care
o Basic research findings demonstrated the anti-tumor
effects of tamoxifen in lab animals.
o Clinical researchers showed that tamoxifen shrank
breast tumors in afflicted women and reduced the risk of
tumor recurrence.
o Clinical researchers also demonstrated that healthy women treated with
tamoxifen were less likely to develop breast cancer.
o Tamoxifen is now widely used as a breast cancer treatment and
prevention.
Clinical Trial Phases
o Clinical trials take place in phases.
o For a treatment to become standard, it must first go
through 3 or 4 clinical trial phases. The early phases
make sure the treatment is safe. Later phases show if
it works better than the standard treatment. You do not
have to take part in all phases.
o Phase I, II, III, IV
Phase I and II
Phase I
Purpose:
o To find a safe dose
o To decide how the new treatment should be given
o To see how the new treatment affects the human body
Number of people taking part: 15–30
Phase II
Purpose:
o To determine if the new treatment has an effect on a certain cancer
o To see how the new treatment affects the human body
Number of people taking part: Fewer than 100
Phase III and IV
Phase III
Purpose:
o To compare the new treatment (or new use of a treatment) with the
current standard treatment
Number of people taking part: From 100 to several thousand
Phase IV
Purpose:
o To further assess the long-term safety and effectiveness of a new
treatment
Number of people taking part: Several hundred to several thousand
Clinical Trials Follow Strict Guidelines.
o Every trial has a person in charge, usually a doctor, who is called the
principal investigator. The principal investigator prepares a plan for the
study, called a protocol, which is like a recipe for conducting a clinical
trial.
o The protocol explains what the trial will do; how the study will be carried
out; why each part of the study is necessary; the reason for doing the
study; who can join the study; how many people are needed for the
study; any drugs they will take, the dose, and how often; what medical
tests they will have and how often; and what information will be gathered
about them.
http://clinicaltrials.gov/ct/info/whatis#types
Clinical Trial Procedure
Who can join a clinical trial?
o Based on the questions the research is trying to answer, each clinical
trial protocol clearly states who can or cannot join the trial.
o Common criteria for entering a trial include: having a certain type or
stage of cancer or having received a certain kind of therapy in the
past.
o Criteria such as these help ensure that people in the trial are as alike
as possible.
Clinical Trial Criteria
These criteria also help ensure:
o Safety: Some people have health problems besides cancer that could
be made worse by the treatments in a study. If you are interested in
joining a trial, you will receive medical tests to be sure that you are not
put at increased risk.
o Accurate and meaningful study results: You may not be able to join
some clinical trials if you already have had another kind of treatment for
your cancer. Otherwise, doctors could not be sure whether your results
were due to the treatment being studied or other factors.
Randomization
o Randomization is used in all phase III and some phase II trials. These trials
are called randomized clinical trials.
o Comparing these groups to each other often clearly shows which treatment
is more effective or has fewer side effects. If you are thinking about joining a
randomized clinical trial, you need to understand that there is an equal
chance you will be assigned to either group. Neither you nor your doctor
chooses which group you will be in.
Placebo
o A placebo is designed to look like the medicine being
tested, but it is not active. Placebos are almost never used
in cancer treatment trials. In some cases, a study may
compare standard treatment plus a new treatment to
standard treatment plus a placebo. You will be told if the
study uses a placebo.
Patient Safety
Federal rules help ensure that clinical trials are run in an ethical manner.
Your rights and safety are protected through:
Informed consent
Careful review and approval of the clinical trial protocol by:
o Scientific experts
o An institutional review board (IRB)
Ongoing monitoring of the trial by:
o The IRB
o Data and Safety Monitoring Boards (DSMBs) for phase 3 trials
o The organization sponsoring the trial
o The research team
Informed Consent
Informed consent is a process through which you learn details about the trial before
deciding whether to take part.
The team explains the trial's:
o Purpose
o Procedures
o Risks and benefits
You can:
o Make a decision about participating
o Leave the study at any time
o Learn about all your treatment options
o Learn all that is involved in the trial including all details about treatment, tests,
and possible risks and benefits
o Discuss the trial with the principal investigator and other members of the
research team
o Both hear and read the information in language you can understand
Ending Trials Early
In some cases, a trial might be stopped because:
o It is going very well. If there is clear evidence early-on that a new
treatment or intervention is effective, then the trial may be halted so
that the new treatment can be made widely available as soon as
possible.
o If participants are experiencing unexpected and severe side effects
or if there is clear evidence that the harms are outweighing the
benefits
o Enough patients cannot be recruited.
o The results of other trials are published that answer the question or
make it irrelevant.
Possible Benefits Of Clinical Trials
o You will have access to a new treatment that is not
available to people outside the trial.
o The research team will watch you closely.
o If the treatment being studied is more effective than the
standard treatment, you may be among the first to
benefit.
o The trial may help scientists learn more about cancer
and help people in the future.
Possible Risks Of Clinical Trials
o The new treatment may not be better than, or even as good as, the
standard treatment.
o New treatments may have side effects that doctors do not expect or
that are worse than those of the standard treatment.
o You may be required to make more visits to the doctor than if you
were receiving standard treatment. You may have extra expenses
related to these extra visits such as travel and childcare costs.
o You may need extra tests. Some of the tests could be uncomfortable
or time consuming.
o Even if a new treatment has benefits in some patients, it may not
work for you.
o Health insurance may not cover all patient care costs in a trial.
Paying for Clinical Trials
Patient care costs:
o Doctor visits
o Hospital stays
o Standard cancer treatments
o Treatments to reduce or eliminate symptoms of cancer or side
effects from treatment
o Lab tests
o X-rays and other imaging tests
Research costs:
o The study drug
o Lab tests performed purely for research purposes
o Additional x-rays and imaging tests performed solely for the trial
Insurance Coverage and Clinical Trials
Federal law requires most health insurance plans to cover routine patient
care costs in clinical trials under certain conditions. Such conditions
include:
o You must be eligible for the trial.
o The trial must be an approved clinical trial.
Which costs are not covered?
o Health plans are not required to cover the research costs of a clinical
trial. Examples of these costs include extra blood tests or scans that
are done purely for research purposes. Often, the trial sponsor will
cover such costs.
o Plans are also not required to cover the costs of out-of-network doctors
or hospitals if the plan does not usually do so. But if your plan does
cover out-of-network doctors or hospitals, they are required to cover
these costs if you take part in a clinical trial.
Who Funds Clinical Research?
o Federal Government
– National Institutes of Health
– Department of Veterans Affairs
– Department of Defense
o State and Local Governments
o Private Organizations
– Foundations and other not-for-profits
– Industry
How to Join a Cancer Clinical Trial
o Step 1: Gather Details about Your Cancer
o Step 2: Find Clinical Trials
o Step 3: Take a Closer Look at the Trials
that Interest You
o Step 4: Contact the Team Running the
Trial
o Step 5: Ask Questions
o Step 6: Make an Appointment
Finding Clinical Trials
o The National Cancer Institute, drug companies, medical institutions,
and other organizations sponsor clinical trials. Clinical trials take place
in many settings such as cancer centers, large medical centers, small
hospitals, and doctors’ offices.
o The National Cancer Institute maintains a list of thousands of cancer
clinical trials. Contact us to see which ones you might be eligible for.
o To reach the National Cancer Institute: Call: 1-800-4-CANCER (1-800422-6237) Visit: http://www.cancer.gov Chat:
http://www.cancer.gov/livehelp E-mail: [email protected]
o https://clinicaltrials.gov/
o Clinical Advocacy Groups
Thank You!!