Clinical Trial
Clinical Trial
Clinical Trial
•Pelatihan GCP
•RS Dr. Kariadi, Semarang; 28 -29 Sept. 2015
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INTRODUCTION
What are Clinical Trials and Why Investigate Them?
• Scientific discoveries are providing more and more insights
into the causes of diseases. Many of these successes are
limited to the laboratory and have yet to be translated into
improved care for people with diseases.
• A clinical trial is a test of a new treatment in patients.
Medicine is extremely conservative in nature, and it takes
many years for a treatment to become generally available
even after it has shown promising results in patients.
• Clinical trials are a critical part of the research process.
Clinical trials help to move basic scientific research from the
laboratory into treatments for people. By evaluating the
results of these trials, we can find better treatments and
ways to prevent, detect, and treat diseases. 7/19/2019
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INTRODUCTION
• Clinical trials are research studies involving
people.They seek to answer specific scientific
questions to find better ways to prevent,
detect, and treat diseases, and to improve care
for people with diseases.
• Clinical trials differ by type of trial and phase
of trial. Each clinical trial follows a set of strict
scientific guidelines called a protocol.
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Why Do Clinical Trial?
• To answer clinical problems
• To gain new knowledge about a new
or established treatment
• To support “claim”
– For gaining government regulatory
approval
– For marketing drug, device or technique
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LEARNING OBJECTIVES
By reading this section and completing the
exercises, you will be able to:
• Define clinical trials
• Name the different types and phases of
clinical trials
• Describe how participants are assigned to
groups in "randomized" clinical trials
• Review the purpose of a clinical trial protocol
and its importance.
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TYPES CLINICAL TRIALS
• Treatment trials
– What new treatment approaches can help
people who have cancer?
– What is the most effective treatment for
people who have cancer?
• Prevention trials
– What approaches can prevent a specific type
of cancer from developing in people who have
not previously had cancer?
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TYPES OF CLINICAL TRIALS
• Early-detection/screening trials
– What are new ways of finding cancer in people before
they have any symptoms?
• Diagnostic trials
– How can new tests or procedures identify cancer more
accurately and at an earlier stage?
• Quality-of-life/supportive care trials
– What kind of new approaches can improve the comfort
and quality of life of people who have cancer?
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PHASES CLINICAL TRIALS
• Phase 1 Trials
• Phase 2 Trials
• Phase 3 Trials
• Phase 4 Trials
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PHASES CLINICAL TRIALS
Phase 1 Phase 2 Phase 3 Phase 4
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RANDOMIZATION
How Participants Are Assigned in Randomized Trials
• Phase 3 studies are randomized clinical trials. Some phase
2 trials may also be randomized.
• Randomization is used to prevent bias in research.
Participants are assigned to either the investigational
group or the control group by chance, via a computer
program, or with a table of random numbers.
Randomization ensures that unknown factors do not
influence the trial results.
– The control group is made up of people who will get the
standard treatment for their disease.
– The investigational group is made up of people who will get
the new drug being tested.
• Anyone who is considering participation in a randomized
clinical trial needs to understand that she or he has 7/19/2019
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equal chance to be assigned to one of the groups. 18
RANDOMIZATION
Why Is Randomization Important?
• If participants or doctors choose a particular group
based on what they think is best, then one of the
groups would likely be very different than the
other, making comparison between the groups
difficult.
• Randomization eliminates this bias because
participants have an equal chance of being
assigned to either group are as similar as possible.
• Comparing similar groups of people taking different
treatments for the same type of disease is a way to
ensure that the study results are caused by the
treatments rather than by chance or other factors.
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GUIDING PRINCIPLES
• Ethics
• Scientific validity and integrity
• Medical relevance
• Regulatory and medicolegal
issues
• Cost
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WHAT IS STEP ONE?
• Start it with hypothesis
– Must be in the form of statement
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