Questions to ask if you participate in Clinical Research:
Why is this experiment being conducted?
Who is doing the study?
Will I be able to continue to see my own doctor?
Is there any cost to me or will I be paid to participate in this study?
Does anyone receive money for my enrollment in the study?
How long will this study last?
What tests or treatments will be used in the study?
What other options or choices do I have if I decide not to take part in this
study?
Can I stop participating in the study if I change my mind?
Could there be any danger to me if I stop participating?
Whom do I contact for answers to questions and information about the study?
Do you have any patient advocates independent of your institution that I can
talk to?
What will happen to me at the end of the study? Will I be told the results
of the study?
What at the differnet phases of clinical trials?
Phase I Trials: In these studies, a drug is given to
small groups of healthy people (typically 20 to 80) for the very first time to
determine and establish safety and tolerance of the drug in humans.
Phase II Trials: The drug is given to larger groups (typically
100 to 200 volunteers) with the disease/condition to further define and determine
an appropriate range of doses and learn more about drug safety and drug effectiveness.
Phase III Trials: The drug is now given to larger groups
(hundreds to thousands) of people to establish efficacy and expand what is known
about the drug’s safety with a selected dose in a broader subject sample.
Phase IV Trials: Studies done after a drug is approved. This
is a very large group (typically thousands) of subjects - larger than Phases
1-3 - to continue to monitor safety in larger populations.
What is a clinical trial?
Drugs and medical devices must be proven safe and effective in people before
the U.S. Food and Drug Administration (FDA) will approve them for general use.
A clinical trial is a study that tests a drug or medical device to see if it
is safe and effective for treating people. The government has strict rules for
clinical trials. These rules help to ensure that study participants are safe.
What is a protocol?
A protocol is a written plan that describes the goal of a research study and
how the study will be conducted. For example, it describes the type of people
needed to take part in the study. The protocol also outlines any procedures the
participants will undergo.
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