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About Clinical Trials
Advanced Prostate Cancer Clinical Trial >> About Clinical Trials
What is a clinical trial?
Why are there different trial phases?
What are the benefits and risks of participating in a trial?
Why are placebos used?
How do you qualify for a clinical trial?
Can you leave a clinical trial after it starts?
What is a clinical trial?
A clinical trial is a research study involving human volunteers.
Some clinical trials test the effectiveness and safety of new,
experimental treatments; others study existing treatments used
in new ways.
Why are there different trial phases?
Before any new product can be sold, it has to go through a series of
rigorous testing phases. If a product completes one phase successfully,
it can proceed to the next.
- Phase 1: Focus is on safety, dosage and side effects. Phase 1 trials usually
involve a small group of participants (20 - 80 people).
- Phase 2: Focus is on effectiveness; safety issues continue to be studied also.
Involves a larger group of study participants (100 - 300 people).
- Phase 3: Aims to confirm effectiveness, side effects and comparison to
other treatments. Involves an even larger group of participants, in some cases,
more than 1,000.
After completing Phase 3 studies, a trial sponsor can collect the findings
and apply for FDA (Food and Drug Administration) approval to sell its treatment.
For many treatments, there are also Phase 4 trials that take place after product
approval.
What are the benefits and risks of participating in a trial?
Benefits/Opportunities
- Take an active role in your own health care.
- Get expert medical care at leading healthcare facilities.
- Help others by contributing to medical research.
Risks
- The possibility of unpleasant, serious or even life-threatening
side effects.
- The possibility that treatment may not be effective for you.
- In some cases, study rules or procedures that require more
time or effort than you may want to give (e.g. travel to study sites, hospital
stays, number of treatments).
- You may receive a placebo (inactive product).
Why are placebos used?
A placebo is an inactive substance (e.g., pill, liquid or powder) that does not have any treatment
value. In clinical trials, experimental treatments are often compared with placebos
so that researchers can assess the treatment's effectiveness. In some studies, one group
of participants(the "control group") receives the placebo while another group receives
the treatment being studied.
How do you qualify for a clinical trial?
Each clinical trial has its own specific guidelines about who can participate. Guidelines help ensure that
the trial will produce scientifically reliable results. Guidelines may include such factors
as a specific type or stage of an illness, treatment history, age, gender and other medical conditions.
Some clinical trials need healthy participants as well as people with the disease or condition.
It is important to note that the guidelines are not used to reject people personally. The guidelines
are used to identify appropriate participants and keep them safe and, again, to ensure that the
results will be scientifically sound.
Can you leave a clinical trial after it starts?
Yes. A participant can leave a clinical trial at any point. If deciding to withdraw from a trial, the participant
should inform the study team of the reasons for leaving.
